Modular Study to Evaluate CT7001 Alone in Cancer Patients... | NCT03363893 | Trialant
NCT03363893
Sponsor
Carrick Therapeutics Limited
Status
Completed
Last Update Posted
Jun 23, 2026Actual
Enrollment
124Actual
Phase
Phase 1Phase 2
Conditions
Advanced Solid Malignancies
Interventions
CT7001
Fulvestrant
Countries
United States
United Kingdom
Protocol Section
Identification Module
NCT ID
NCT03363893
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
CT7001_001
Secondary IDs
ID
Type
Description
Link
2017-002026-20
EudraCT Number
Brief Title
Modular Study to Evaluate CT7001 Alone in Cancer Patients With Advanced Malignancies
Official Title
A Modular, Multipart, Multiarm, Open-label, Phase I/II Study to Evaluate the Safety and Tolerability of CT7001 Alone and in Combination With Anti-cancer Treatments in Patients With Advanced Malignancies
Acronym
Not provided
Organization
Carrick Therapeutics LimitedINDUSTRY
Status Module
Record Verification Date
May 2026
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Nov 14, 2017Actual
Primary Completion Date
Dec 15, 2022Actual
Completion Date
Dec 15, 2022Actual
First Submitted Date
Nov 27, 2017
First Submission Date that Met QC Criteria
Nov 30, 2017
First Posted Date
Dec 6, 2017Actual
Results Waived
Not provided
Results First Submitted Date
Dec 10, 2025
Results First Submitted that Met QC Criteria
May 26, 2026
Results First Posted Date
Jun 23, 2026Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Dec 13, 2023
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Jun 23, 2026Actual
Last Update Submitted Date
May 26, 2026
Last Update Posted Date
Jun 23, 2026Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Carrick Therapeutics LimitedINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
This is a modular, Phase I/II, multicentre study to investigate CT7001 monotherapy in advanced solid malignancies and to further investigate CT7001 as monotherapy or in combination with standard therapy in specific participant groups with Triple Negative Breast Cancer (TNBC), Castrate Resistant Prostate Cancer (CRPC) and in combination with fulvestrant for patients with hormone receptor-positive (HR+ve) / human epidermal growth factor-2 negative (HER2-ve) breast cancer.
Detailed Description
Module 1 comprises two sequential parts:
Part A: First-in-human (FiH) dose escalation investigating the safety and tolerability of CT7001 to identify the minimum biologically active dose (MBAD) and maximum tolerated dose (MTD). Part A also includes a cohort expansion for breast cancer participants only: this includes sequential tumour biopsies for evaluation of pharmacokinetic (PK), pharmacodynamic (PD) and tumour responses. The module is completed.
Part B: To refine the safety, tolerability, and PK and PD profiles of CT7001 monotherapy in participants with advanced solid malignancies from up to four tumour- specific cohorts, which may include, but is not limited to, triple-negative breast cancer, ovarian cancer, small-cell lung cancer and prostate cancer.
Part B, Cohort 1, Triple-Negative Breast Cancer (M1B-1 TNBC) treated with CT7001 as monotherapy. The module is completed.
Part B, Cohort 2, Prostate Cancer (M1B-2 CRPC) treated with CT7001 as monotherapy. The module is completed.
Module 2 is a Phase Ib/II, 3-part safety and efficacy study in participants with hormone- receptor positive (HR+ve) and human epidermal growth factor-2 negative (HER2-ve) breast cancer. This module includes dosing CT7001 in combination with fulvestrant. Module 2 was planned to comprise of 3 parts; Part A (open-label, single-arm, ascending dose study), Part B (double blinded, randomised, placebo-controlled study) and Part C (crossover from Part B). However, only Module 2 Part A was initiated and completed. Therefore, further sections of this record only reflect Module 2 Part A information.
Module 4 is a study investigating the effect of food on the PK of CT7001 monotherapy in participants with advanced solid malignancies. The module is completed.
Module 6 was planned as a Phase 1 study to explore the tolerability of, and the total and peak exposure of, an enteric capsule formulation of CT7001 [CT7001(EC)], when given as monotherapy to patients with advanced solid malignancies. Module 6 was not initiated.
Conditions Module
Conditions
Advanced Solid Malignancies
Keywords
Neoplasms
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 1Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
124Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Module 1 Part A Multiple ascending dose cohort and Paired Biopsy Breast Cancer Expansion Cohort
Experimental
Module 1 Part A Multiple ascending dose cohort: Participants with advanced solid tumours receive CT7001 (samuraciclib) as oral monotherapy, in ascending dose cohorts, to identify the maximum tolerated dose (MTD), minimally biologically active dose (MBAD) and recommended dose for Phase II testing (RP2D).
Following completion of the dose escalation part of Module 1A, participants to receive safe, tolerable and MBAD of CT7001 for the paired biopsy expansion cohort.
Module 1 Part A Paired Biopsy Breast Cancer Expansion Cohort: Participants with locally advanced or metastatic breast cancer will receive CT7001 (samuraciclib) as oral monotherapy at the minimally biologically active dose (MBAD) and recommended dose for Phase II testing (RP2D).
Drug: CT7001
Module 1 Part B-1 Triple-negative breast cancer (TNBC) Expansion
Experimental
Participants with locally advanced or metastatic triple-negative breast cancer (TNBC) will receive CT7001(samuraciclib) as oral monotherapy at the dose, frequency and schedule recommended from Module 1 Part A.
Drug: CT7001
Module 1 Part B-2 Castrate resistant prostate Cancer (CRPC) Expansion
Experimental
Participants with castrate resistant prostate cancer will receive CT7001(samuraciclib) as oral monotherapy at the dose, frequency and schedule recommended from Module 1 Part A.
Drug: CT7001
Module 2 Part A
Experimental
Participants with locally advanced or metastatic HR+ve and HER2-ve breast cancer will receive CT7001 (samuraciclib) at the dose, frequency and schedule recommended from Module 1 part A and will receive Fulvestrant solution in pre-filled syringe for intramuscular (IM) injection
Interventions
Name
Type
Description
Arm Group Labels
Other Names
CT7001
Drug
Cyclin-dependent kinase 7 (CDK7) inhibitor given orally once daily until disease progression
Module 1 Part A Multiple ascending dose cohort and Paired Biopsy Breast Cancer Expansion Cohort
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Treatment-Emergent Adverse Events and Laboratory Abnormalities (Safety and Tolerability)
Treatment-emergent adverse events (TEAEs) are defined as those AEs which occur from Cycle 0 Day 1/Cycle 1 Day 1 of the study module to 28 days after the last dose of CT7001 in a module.
Results reported below for Participants with one or more related TEAEs.
Screening to end of study (28-35 calendar days after end of treatment). End of treatment at disease progression, unacceptable toxicity or withdrawal of consent. Average time on study 142.6 days (range 9 - 1135 days)
Secondary Outcomes
Measure
Description
Time Frame
Maximum Plasma Concentration of CT7001 (Cmax)
Cmax is the maximum observed plasma concentration of CT7001 following oral dosing.
After the first dose and during the dosing period (from the time of dose administration to 24 hours) for Module 1A cohorts. Pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 24, 48, 72, 120 and 168 hours post dose for Module 4 Cohorts.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Core Inclusion Criteria:
ECOG performance status 0 or 1 with no deterioration over the previous 2 weeks
Estimated life expectancy of greater than 12 weeks
Ability to swallow and retain oral medication
Women either of non-childbearing potential or of childbearing potential willing to practice effective contraception for the duration of the study and for 6 months (Module 1, Module 4) and 24 months (Module 2) after the last dose of CT7001
Sexually active male patients must be willing to use condoms with all sexual partners for the duration of the study and for 3 months after the last dose of CT7001.
Provision of signed and dated, written informed consent
Core Exclusion Criteria:
Any other malignancy that has been active or treated within the past 3 years, with the exception of cervical intraepithelial neoplasia and non-melanoma skin cancer
Any unresolved toxicity (except alopecia) from prior therapy of ≥ CTCAE Grade 2
Spinal cord compression or brain metastases, unless asymptomatic, stable, and not requiring steroids for at least 4 weeks before the first dose of investigational product (IP)
Refractory nausea and vomiting, chronic gastrointestinal (GI) disease or previous significant bowel resection, with clinically significant sequelae that would preclude adequate absorption of CT7001
Uncontrolled seizures
Active infection requiring systemic antibiotic, antifungal, or antiviral medication
Severe or uncontrolled medical condition or psychiatric condition
Active bleeding diatheses
Renal transplant
Known hepatitis B, hepatitis C, or human immunodeficiency virus infection
Breastfeeding or pregnancy
Receipt of systemic cytotoxic treatment for the malignancy within 28 days or ≤ 5 half-lives, whichever is shorter before the first dose of IP
Receipt of non-cytotoxic treatment for the malignancy within 5 half-lives of the drug before the first dose of IP
Receipt of corticosteroids (at a dose > 10 mg prednisone/day or equivalent) within 14 days before the first dose of IP
Receipt of any small-molecule investigational medicinal product (IMP) within 28 days or ≤ 5 half-lives, whichever is shorter before the first dose of IP
Receipt of any biological IMP (e.g., immune checkpoint blockers, antibodies, nanoparticles) within 42 days before the first dose of IP
Receipt of St John's Wort within 21 days before the first dose of IP or of another concomitant medication, herbal supplement, or food that is a strong inhibitor or inducer of CYP3A4, CYP2C19, CYP2D6, or P-glycoprotein (PGP) activity within 14 days before the first dose of CT7001
Receipt of a blood transfusion (blood or blood products) within 14 days before the first dose of IP
Known hypersensitivity to CT7001 or any excipient of the product
Impaired hepatic or renal function as demonstrated by any of the following laboratory values:
Albumin < 30 g/L
Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 2.5 × the upper limit of normal (ULN)
> 5.0 × ULN for patients with liver metastases
Total bilirubin > 1.5 × ULN
Serum creatinine > 1.5 × ULN
Liver function deteriorating in a manner that would likely make the participant meet the AST, ALT, or bilirubin levels specified above at the time of the first dose of IP
Other evidence of impaired hepatic synthesis function
Inadequate bone marrow reserve or organ function as demonstrated by any of the following laboratory values:
Absolute neutrophil count (ANC) < 1.5 × 10^9/L
Platelet count < 100 × 10^9/L
Haemoglobin < 90 g/L
Persistent (> 4 weeks) severe pancytopenia due to previous therapy rather than to disease (ANC < 0.5 × 10^9/L or platelets < 50 x 10^9/L)
Cardiac dysfunction (defined as myocardial infarction within 6 months of study entry, New York Heart Association Class II/III/IV heart failure, unstable angina, unstable cardiac arrhythmias, or left ventricular ejection fraction < 55 percent)
Mean resting QT interval corrected for heart rate by the Fridericia formula (QTcF) > 470 msec obtained from 3 electrocardiograms (ECGs) obtained within 5 minutes of each other prior to the first dose
Any clinically important abnormalities in rhythm, conduction, or morphology on resting ECG (e.g., complete left bundle branch block, third degree heart block). Controlled atrial fibrillation (AF) is permitted
Any factor that increases the risk of QTc prolongation or of arrhythmic events (e.g., heart failure, hypokalaemia, congenital long QT syndrome, immediate family history of long QT syndrome or unexplained sudden death under 40 years of age)
In the opinion of the Investigator, unlikely to comply with study procedures, restrictions, or requirements
A history of haemolytic anaemia or marrow aplasia
Has received a live-virus vaccination within 28 days or less of planned treatment start
Additional Module 1A Inclusion Criteria:
Histological, radiological or cytological confirmation of an advanced non-haematological malignancy not considered to be appropriate for further standard treatment
Module 1A biopsy cohort only : at least one tumour suitable for repeat biopsy
Additional Module 1A Exclusion Criteria:
1. International normalised ratio (INR) ≥1.5
Additional Module 1B Inclusion Criteria
Histological or cytological confirmation of metastasis or locally advanced tumour
Histologically-confirmed carcinoma of breast not expressing oestrogen receptor (ER) or progesterone receptor (PR) and negative for human epidermal growth factor receptor 2 (HER2)
Documented disease progression on or within 6 months of most recent cytotoxic prior cytotoxic chemotherapy
Disease measurable by RECIST v1.1
Must have received at least one cytotoxic chemotherapy for metastatic/locally advanced disease
No more than three lines of cytotoxic chemotherapy for metastatic/locally advanced disease
No advanced, symptomatic visceral metastases
No known symptomatic central nervous system (CNS) metastases, carcinomatous meningitis or leptomeningeal disease
Prior exposure to CT7001
Patients who are investigational site staff members directly involved in the conduct of the trial and their family members, site staff members otherwise supervised by the Investigator, or patients who are Carrick employees directly involved in the conduct of the trial
Additional Module 2A Inclusion Criteria:
Women only
Pre- or peri-menopausal women must have initiated LHRHa at least 28 days prior to first dose of CT7001/placebo
Histologically-confirmed, metastatic or locally advanced, ER+ve and/or PGR+ve and HER2-ve breast cancer
Disease measurable by RECIST v1.1
Documented objective disease progression while on, or within 6 months after the end of, the most recent therapy
Must have received an aromatase inhibitor together with a CDK4/6 inhibitor in the same line of therapy for locally advanced or metastatic disease or for treatment of early breast cancer if the disease-free interval was <12 months.
Ability to receive intramuscular injections.
Additional Module 2A Exclusion Criteria:
Prior therapy with fulvestrant
More than 2 lines of endocrine treatment for locally advanced or metastatic disease
Prior treatment with more than one line of cytotoxic chemotherapy for locally advanced or metastatic breast cancer.
Patients with liver metastasis will be limited to approximately 30-40% of the enrolled patients. l
Known hypersensitivity to CT7001, fulvestrant or any excipient of the investigational products
Patients who are investigational site staff members directly involved in the conduct of the trial and their family members, site staff members otherwise supervised by the Investigator, or patients who are Carrick employees directly involved in the conduct of the trial
Additional Module 4 Inclusion Criteria:
Patients must be able to eat a high-fat meal, as provided by the study site, within a 30-minute period
Histological, radiological or cytological confirmation of an advanced non-haematological malignancy not considered to be appropriate for further standard treatment
Additional Module 4 Exclusion Criteria:
1. Patients who were unable to fast for at least 10 hours
Coombes RC, Howell S, Lord SR, Kenny L, Mansi J, Mitri Z, Palmieri C, Chap LI, Richards P, Gradishar W, Sardesai S, Melear J, O'Shaughnessy J, Ward P, Chalasani P, Arkenau T, Baird RD, Jeselsohn R, Ali S, Clack G, Bahl A, McIntosh S, Krebs MG. Dose escalation and expansion cohorts in patients with advanced breast cancer in a Phase I study of the CDK7-inhibitor samuraciclib. Nat Commun. 2023 Jul 24;14(1):4444. doi: 10.1038/s41467-023-40061-y.
A total of 174 participants were recruited, of which 124 participants were enrolled and went on to receive study treatment with CT7001. Of the 174 participants screened, 50 participants did not receive study treatment, of which 46 participants did not meet the study enrolment criteria and 4 participants withdrew from the study.
Recruitment Details
This study recruited participants at least 18 years of age with histological or cytological confirmation of an advanced malignancy, with an Eastern Cooperative Oncology Group (ECOG) status of 0 or 1 and an estimated life expectancy greater than 12 weeks.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Module 1 Part A-Cohort 1 120mg OD
Dose Escalation Phase-Participants received a single dose of CT7001 on Day 1 of Cycle 0 (C0D1) followed by a 2-day washout period (C0D2), before receiving cycles of 21 continuous days dosing of CT7001 capsules. Dosing was continued until the participant was no longer gaining clinical benefit or another treatment discontinuation criterion was met, at which time an end of treatment visit was conducted.
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Not provided
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Not provided
Uploaded Document Information
Type
Includes Protocol
Includes SAP
Includes ICF
Document Label
Document Date
Document Uploaded Date
Document File Name
Prot
Yes
No
No
Study Protocol
Jun 14, 2021
Dec 10, 2025
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
Estimated Results First Submitted Date
Not provided
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Modular design
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
None (Open Label)
Masking Description
Not provided
Who Masked
Not provided
Drug: CT7001
Drug: Fulvestrant
Module 4
Experimental
Participants with advanced solid tumours will receive CT7001(samuraciclib) oral monotherapy in a randomized, balanced, single-dose, two-treatment (fed v fasting), two-period, two-sequence crossover study followed by once daily continuous dosing.
Drug: CT7001
Module 1 Part B-1 Triple-negative breast cancer (TNBC) Expansion
Module 1 Part B-2 Castrate resistant prostate Cancer (CRPC) Expansion
Module 2 Part A
Module 4
Samuraciclib
Fulvestrant
Drug
Administered as 2 x 250mg intramuscular (IM) gluteal injections on Day 1, Day 15, Day 28 and every 28 days thereafter.
Module 2 Part A
Faslodex
Area Under the Curve (AUC)
Area under the plasma concentration-time curve representing the total drug exposure over time.
After the first dose and during the dosing period (from the time of dose administration to 24 hours) for Module 1A. Pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 24, 48, 72, 120 and 168 hours post dose for Module 4 Cohorts.
Mean Trough Plasma Pharmacokinetic Concentrations for CT7001
Mean Trough Plasma Pharmacokinetic Concentrations is the lowest concentration of a drug in the bloodstream during a dosing interval.
Timeframe: On study sampling: M1A - Day 1, 8, 15, 22, 29, 43, 50, every 21 days thereafter and EOT. M1B-1 and M1B-2: Day1, 8, 22, every 21 days thereafter and EOT. M2A: Day1, 15, 29, 57, every 56 days thereafter and EOT. M4: Day 1, 8, 15, 22, 29, 36, every 21 days thereafter and EOT.
From enrolment (Day 1) through to disease progression, unacceptable toxicity or withdrawal of consent, whichever came first (EOT). Assessed up to 1135 days. On study pre-dose sampling for all modules (see outcome measure description).
Mean Trough Plasma Pharmacokinetic Concentrations for Fulvestrant (Module 2A)
Mean trough plasma PK concentrations refer to the lowest concentration of a drug in the bloodstream during a dosing interval.
From enrolment through to disease progression, unacceptable toxicity or withdrawal of consent, whichever came first (EOT). Pre-dose sampling at Day 1, 15, 29, 57 and every 56 days thereafter and EOT. Assessed up to 848 days.
Anti-tumour Activity According to RECIST v1.1-Best Objective Response
Antitumour activity endpoints were analysed using the evaluable for Response population (any patient with at least one post baseline RECIST assessment).
Best objective response is defined as the best response recorded from the start of study treatment to the end of treatment, including any assessments for confirmation after the end of treatment. Percentage of participants with each response calculated was based on the total number of participants with a baseline RECIST assessment.
Timeframe: Scan frequency - Modules 1A and 4 (every 6 weeks); Modules 1B-1 and 2A (every 8 weeks first year, every 12 weeks thereafter); Module 1B-2 (every 8 weeks for the 6 months, every 12 weeks thereafter).
From enrolment (Day 1) until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 1135 days (162 weeks). Frequency in outcome measure description.
Anti-tumour Activity According to RECIST v1.1-Progression Free Survival
Antitumour activity endpoints were analysed using the evaluable for Response population based on RECIST assessment.
Progression free survival is defined as the time from start of treatment until the date of objective disease progression or death (by any cause in the absence of progression) regardless of whether the participant had withdrawn from therapy or had received another anti-cancer therapy prior to progression. Participants who had not progressed or died at the time of analysis were censored at the time of the latest date of assessment from their last evaluable RECIST assessment.
From enrolment (Day 1) until the date of first documented progression or date of death from any cause, whichever came first. Modules 1B-1 and 2A: every 8 weeks first year, every 12 weeks thereafter) assessed up to 848 days (121 weeks).
Anti-tumour Activity According to RECIST v1.1-Clinical Benefit Rate (CBR)
Antitumour activity endpoints were analysed using the evaluable for Response population based on RECIST assessment.
Clinical Benefit Rate (CBR) is defined as the percentage of subjects with a confirmed objective response of complete response or partial response, or stabilisation of disease for at least 24 weeks.
From enrolment (Day 1) until the date of first documented progression or date of death from any cause, whichever came first. Module 2A: every 8 weeks first year, every 12 weeks thereafter) assessed up to 848 days (121 weeks).
Beverly Hills
California
90211
United States
Research Site 37
Tampa
Florida
33612
United States
Research Site 38
Chicago
Illinois
60611
United States
Research Site 34
Boston
Massachusetts
02215
United States
Research Site 47
Cincinnati
Ohio
45236
United States
Research Site 39
Columbus
Ohio
43212
United States
Research Site 36
Portland
Oregon
97239
United States
Research Site 44
Austin
Texas
78705
United States
Research Site 46
Dallas
Texas
75246
United States
Research Site 48
Salt Lake City
Utah
84112
United States
Research Site 33
Salem
Virginia
24153
United States
Research site 11
Brighton
BN2 5BE
United Kingdom
Research site 5
Cambridge
CB2 0QQ
United Kingdom
Research Site 7
Glasgow
G12 0YN
United Kingdom
Research Site 10
Liverpool
L69 3BX
United Kingdom
Research Site 9
London
SE1 9RT
United Kingdom
Research Site 8
London
W1G 6AD
United Kingdom
Research Site 3
London
W2 1NY
United Kingdom
Research Site 1
Manchester
M20 4BX
United Kingdom
Research Site 4
Manchester
M20 4BX
United Kingdom
Research Site 2
Oxford
OX3 7LE
United Kingdom
Research Site 6
Southampton
SO16 6YD
United Kingdom
Derived
Sava GP, Fan H, Coombes RC, Buluwela L, Ali S. CDK7 inhibitors as anticancer drugs. Cancer Metastasis Rev. 2020 Sep;39(3):805-823. doi: 10.1007/s10555-020-09885-8.
FG001
Module 1 Part A-Cohort 2 240 mg OD
Dose Escalation Phase-Participants received a single dose of CT7001 on Day 1 of Cycle 0 (C0D1) followed by a 2-day washout period (C0D2), before receiving cycles of 21 continuous days dosing of CT7001 capsules. Dosing was continued until the participant was no longer gaining clinical benefit or another treatment discontinuation criterion was met, at which time an end of treatment visit was conducted. Once the MBAD was determined and agreed by the SRC, the paired biopsy expansion cohort in patients with breast cancer commenced at the selected dose
FG002
Module 1 Part A-Cohort 3 480 mg OD
Dose Escalation Phase-Participants received a single dose of CT7001 on Day 1 of Cycle 0 (C0D1) followed by a 2-day washout period (C0D2), before receiving cycles of 21 continuous days dosing of CT7001 capsules. Dosing was continued until the participant was no longer gaining clinical benefit or another treatment discontinuation criterion was met, at which time an end of treatment visit was conducted.
FG003
Module 1 Part A-Cohort 4 360 mg OD
Dose Escalation Phase-Participants received a single dose of CT7001 on Day 1 of Cycle 0 (C0D1) followed by a 2-day washout period (C0D2), before receiving cycles of 21 continuous days dosing of CT7001 capsules. Dosing was continued until the participant was no longer gaining clinical benefit or another treatment discontinuation criterion was met, at which time an end of treatment visit was conducted.
Once the MBAD was determined and agreed by the SRC, the paired biopsy expansion cohort in patients with breast cancer commenced at the selected dose.
FG004
Module 1 Part A-Cohort 5 180 mg BID
Dose Escalation Phase-Participants received twice daily dose of CT7001 on Day 1 of Cycle 0 (C0D1) followed by a 2-day washout period (C0D2), before receiving cycles of 21 continuous days dosing of CT7001 capsules. Dosing was continued until the participant was no longer gaining clinical benefit or another treatment discontinuation criterion was met, at which time an end of treatment visit was conducted.
FG005
Module 1 Part A Paired Biopsy Breast Cancer Expansion Cohort-240mg
Participants with locally advanced or metastatic breast cancer will receive CT7001 (samuraciclib) as oral monotherapy at the minimally biologically active dose (MBAD) and recommended dose for Phase II testing (RP2D).
FG006
Module 1 Part A Paired Biopsy Breast Cancer Expansion Cohort-360mg
Participants with locally advanced or metastatic breast cancer will receive CT7001 (samuraciclib) as oral monotherapy at the minimally biologically active dose (MBAD) and recommended dose for Phase II testing (RP2D).
FG007
Module 1 Part B-1 Triple-negative Breast Cancer (TNBC) Expansion
Dose Escalation Phase-Participants with locally advanced or metastatic triple-negative breast cancer (TNBC) will receive CT7001(samuraciclib) as oral monotherapy at the dose, frequency and schedule recommended from Module 1 Part A.
CT7001: Cyclin-dependent kinase 7 (CDK7) inhibitor given orally once daily until disease progression
FG008
Module 1 Part B-2 Castrate Resistant Prostate Cancer (CRPC) Expansion
Participants with castrate resistant prostate cancer will receive CT7001(samuraciclib) as oral monotherapy at the dose, frequency and schedule recommended from Module 1 Part A.
CT7001: Cyclin-dependent kinase 7 (CDK7) inhibitor given orally once daily until disease progression
FG009
Module 2 Part A CT7001 240 mg OD + Fulvestrant (Cohort 1)
Participants with locally advanced or metastatic HR+ve and HER2-ve breast cancer will receive CT7001 (samuraciclib) at the dose, frequency and schedule recommended from Module 1 part A and will receive Fulvestrant solution in pre-filled syringe for intramuscular (IM) injection
CT7001: Cyclin-dependent kinase 7 (CDK7) inhibitor given orally once daily until disease progression
Fulvestrant: Administered as 2 x 250mg intramuscular (IM) gluteal injections on Day 1, Day 15, Day 28 and every 28 days thereafter.
FG010
Module 2 Part A CT7001 360 mg OD + Fulvestrant (Cohort 2)
Participants with locally advanced or metastatic HR+ve and HER2-ve breast cancer will receive CT7001 (samuraciclib) at the dose, frequency and schedule recommended from Module 1 part A and will receive Fulvestrant solution in pre-filled syringe for intramuscular (IM) injection.
CT7001: Cyclin-dependent kinase 7 (CDK7) inhibitor given orally once daily until disease progression.
Fulvestrant: Administered as 2 x 250mg intramuscular (IM) gluteal injections on Day 1, Day 15, Day 28 and every 28 days thereafter.
FG011
Module 4-120 mg OD Fed-Fasted (Sequence 1)
Module 4 evaluated the effect of food on the PK of CT7001 using a randomized, balanced, single-dose, two-treatment (fed vs. fasting), two-period, two-sequence crossover design, followed by a continuous treatment phase. Sequence 1: 120 mg CT7001 fed in Period 1 followed by 120 mg CT7001 fasted in Period 2.
FG012
Module 4 120 mg OD Fasted-Fed (Sequence 2)
Module 4 evaluated the effect of food on the PK of CT7001 using a randomized, balanced, single-dose, two-treatment (fed vs. fasting), two-period, two-sequence crossover design, followed by a continuous treatment phase. Sequence 2: 120 mg CT7001 fasted in Period 1 followed by 120 mg CT7001 fed in Period 2.
FG013
Module 4 360 mg OD Fed-Fasted (Sequence 3)
Module 4 evaluated the effect of food on the PK of CT7001 using a randomized, balanced, single-dose, two-treatment (fed vs. fasting), two-period, two-sequence crossover design, followed by a continuous treatment phase. Sequence 3: 360 mg CT7001 fed in Period 1 followed by 360 mg CT7001 fasted in Period 2.
FG014
Module 4 360 mg OD Fasted-Fast (Sequence 4)
Module 4 evaluated the effect of food on the PK of CT7001 using a randomized, balanced, single-dose, two-treatment (fed vs. fasting), two-period, two-sequence crossover design, followed by a continuous treatment phase.
Sequence 4: 360 mg CT7001 fasted in Period 1 followed by 360 mg CT7001 fed in Period 2.
FG0006 subjects
FG0017 subjects
FG0026 subjects
FG0036 subjects
FG0048 subjects
FG0055 subjects
FG0066 subjects
FG00723 subjects
FG00811 subjects
FG0096 subjects
FG01025 subjects
FG0114 subjects
FG0124 subjects
FG0134 subjects
FG0143 subjects
COMPLETED
FG0006 subjects
FG0017 subjects
FG0026 subjects
FG0036 subjects
FG0048 subjects
FG0055 subjects
FG0066 subjects
FG00723 subjects
FG00811 subjects
FG0096 subjects
FG01025 subjects
FG0114 subjects
FG0124 subjects
FG0134 subjects
FG0143 subjects
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Module 1 Part A-Cohort 1 120mg OD
Dose Escalation Phase-Participants received a single dose of CT7001 on Day 1 of Cycle 0 (C0D1) followed by a 2-day washout period (C0D2), before receiving cycles of 21 continuous days dosing of CT7001 capsules. Dosing was continued until the participant was no longer gaining clinical benefit or another treatment discontinuation criterion was met, at which time an end of treatment visit was conducted.
BG001
Module 1 Part A-Cohort 2 240 mg OD
Dose Escalation Phase-Participants received a single dose of CT7001 on Day
of Cycle 0 (C0D1) followed by a 2-day washout period (C0D2), before receiving cycles of 21 continuous days dosing of CT7001 capsules. Dosing was continued until the participant was no longer gaining clinical benefit or another treatment discontinuation criterion was met, at which time an end of treatment visit was conducted. Once the MBAD was determined and agreed by the SRC, the paired biopsy expansion cohort in patients with breast cancer commenced at the selected dose
BG002
Module 1 Part A-Cohort 3 480 mg OD
Dose Escalation Phase-Participants received a single dose of CT7001 on Day
1 of Cycle 0 (C0D1) followed by a 2-day washout period (C0D2), before receiving cycles of 21 continuous days dosing of CT7001 capsules. Dosing was continued until the participant was no longer gaining clinical benefit or another treatment discontinuation criterion was met, at which time an end of treatment visit was conducted.
BG003
Module 1 Part A-Cohort 4 360 mg OD
Dose Escalation Phase-Participants received a single dose of CT7001 on Day
of Cycle 0 (C0D1) followed by a 2-day washout period (C0D2), before receiving cycles of 21 continuous days dosing of CT7001 capsules. Dosing was continued until the participant was no longer gaining clinical benefit or another treatment discontinuation criterion was met, at which time an end of treatment visit was conducted. Once the MBAD was determined and agreed by the SRC, the paired biopsy expansion cohort in patients with breast cancer commenced at the selected dose.
BG004
Module 1 Part A-Cohort 5 180 mg BID
Dose Escalation Phase-Participants received twice daily dose of CT7001 on Day
1 of Cycle 0 (C0D1) followed by a 2-day washout period (C0D2), before receiving cycles of 21 continuous days dosing of CT7001 capsules. Dosing was continued until the participant was no longer gaining clinical benefit or another treatment discontinuation criterion was met, at which time an end of treatment visit was conducted
BG005
Module 1 Part A Paired Biopsy Breast Cancer Expansion Cohort-240mg
Participants with locally advanced or metastatic breast cancer will receive CT7001 (samuraciclib) as oral monotherapy at the minimally biologically active dose (MBAD) and recommended dose for Phase II testing (RP2D)
BG006
Module 1 Part A Paired Biopsy Breast Cancer Expansion Cohort-360mg
Participants with locally advanced or metastatic breast cancer will receive CT7001 (samuraciclib) as oral monotherapy at the minimally biologically active dose (MBAD) and recommended dose for Phase II testing (RP2D).
BG007
Module 1 Part B-1 Triple-negative Breast Cancer (TNBC) Expansion
Participants with locally advanced or metastatic triple-negative breast cancer (TNBC) will receive CT7001(samuraciclib) as oral monotherapy at the dose, frequency and schedule recommended from Module 1 Part A.
CT7001: Cyclin-dependent kinase 7 (CDK7) inhibitor given orally once daily until disease progression
BG008
Module 1 Part B-2 Castrate Resistant Prostate Cancer (CRPC) Expansion
Participants with castrate resistant prostate cancer will receive CT7001(samuraciclib) as oral monotherapy at the dose, frequency and schedule recommended from Module 1 Part A.
CT7001: Cyclin-dependent kinase 7 (CDK7) inhibitor given orally once daily until disease progression
BG009
Module 2 Part A CT7001 240 mg OD + Fulvestrant (Cohort 1)
Participants with locally advanced or metastatic HR+ve and HER2-ve breast cancer will receive CT7001 (samuraciclib) at the dose, frequency and schedule recommended from Module 1 part A and will receive Fulvestrant solution in pre-filled syringe for intramuscular (IM) injection
CT7001: Cyclin-dependent kinase 7 (CDK7) inhibitor given orally once daily until disease progression
Fulvestrant: Administered as 2 x 250mg intramuscular (IM) gluteal injections on Day 1, Day 15, Day 28 and every 28 days thereafter.
BG010
Module 2 Part A CT7001 360 mg OD + Fulvestrant (Cohort 2)
Participants with locally advanced or metastatic HR+ve and HER2-ve breast cancer will receive CT7001 (samuraciclib) at the dose, frequency and schedule recommended from Module 1 part A and will receive Fulvestrant solution in pre-filled syringe for intramuscular (IM) injection. CT7001: Cyclin-dependent kinase 7 (CDK7) inhibitor given orally once daily until disease progression. Fulvestrant: Administered as 2 x 250mg intramuscular (IM) gluteal injections on Day 1, Day 15, Day 28 and every 28 days thereafter.
BG011
Module 4-120 mg OD Fed-Fasted (Sequence 1)
Module 4 evaluated the effect of food on the PK of CT7001 using a randomized, balanced, single-dose, two-treatment (fed vs. fasting), two-period, two-sequence crossover design, followed by a continuous treatment phase.
Sequence 1:
120 mg CT7001 fed in Period 1 followed by 120 mg CT7001 fasted in Period 2. This was followed by ) followed by 240mg OD continuous dosing.
BG012
Module 4 120 mg OD Fasted-Fed (Sequence 2)
Module 4 evaluated the effect of food on the PK of CT7001 using a randomized, balanced, single-dose, two-treatment (fed vs. fasting), two-period, two-sequence crossover design, followed by a continuous treatment phase.
Sequence 2:
120 mg CT7001 fasted in Period
1 followed by 120 mg CT7001 fed in Period 2. ). This followed by 240mg OD continuous dosing.
BG013
Module 4 360 mg OD Fed-Fasted (Sequence 3)
Module 4 evaluated the effect of food on the PK of CT7001 using a randomized, balanced, single-dose, two-treatment (fed vs. fasting), two-period, two-sequence crossover design, followed by a continuous treatment phase.
Sequence 3:
360 mg CT7001 fed in Period 1 followed by 360 mg CT7001 fasted in Period 2. ). This was followed by 360mg OD continuous dosing
BG014
Module 4 360 mg OD Fasted-Fed (Sequence 4)
Module 4 evaluated the effect of food on the PK of CT7001 using a randomized, balanced, single-dose, two-treatment (fed vs. fasting), two-period, two-sequence crossover design, followed by a continuous treatment phase.
Sequence 4:
360 mg CT7001 fasted in Period
1 followed by 360 mg CT7001 fed in Period 2. This was followed by 360 mg OD continuous dosing
BG015
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG0006
BG0017
BG0026
BG0036
BG0048
BG0055
BG0066
BG00723
BG00811
BG0096
BG01025
BG0114
BG0124
BG0134
BG0143
BG015124
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Categorical
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
<=18 years
BG0000
BG0010
BG0020
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0004
BG0012
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0000
BG0010
BG002
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0000
BG0010
BG002
Region of Enrollment
Number
participants
Title
Denominators
Categories
United States
Title
Measurements
BG0000
BG0010
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Treatment-Emergent Adverse Events and Laboratory Abnormalities (Safety and Tolerability)
Treatment-emergent adverse events (TEAEs) are defined as those AEs which occur from Cycle 0 Day 1/Cycle 1 Day 1 of the study module to 28 days after the last dose of CT7001 in a module.
Results reported below for Participants with one or more related TEAEs.
Results are presented for Participants with one or more related TEAEs. Module 4 crossover cohorts are presented in terms of patients fed/fasted correctly in accordance with the protocol. One participant in 120mg OD Fed cohort deviated from the protocol and data for this participant is therefore reported under 120mg Fasted cohort.
Posted
Count of Participants
Participants
Screening to end of study (28-35 calendar days after end of treatment). End of treatment at disease progression, unacceptable toxicity or withdrawal of consent. Average time on study 142.6 days (range 9 - 1135 days)
ID
Title
Description
OG000
Module 1 PartA-Cohort 1 120mg OD
Dose Escalation Phase-Participants received a single dose of CT7001 on Day1 of Cycle 0(C0D1) followed by a 2-day washout period(C0D2), before receiving cycles of 21 continuous days dosing of CT7001capsules. Dosing was continued until the participant was no longer gaining clinical benefit or another treatment discontinuation criterion was met, at which time an end of treatment visit was conducted.
OG001
Module 1 Part A-Cohort 2 240mg OD
Dose Escalation Phase- Participants received a single dose of CT7001 on Day1 of Cycle 0(C0D1) followed by a 2-day washout period (C0D2), before receiving cycles of 21continuous days dosing of CT7001capsules. Dosing was continued until the participant was no longer gaining clinical benefit or another treatment discontinuation criterion was met, at which time an end of treatment visit was conducted. Once the MBAD was determined and agreed by the SRC, the paired biopsy expansion cohort in patients with breast cancer commenced at the selected dose.
OG002
Module 1 Part A-Cohort 3 480mg OD
Dose Escalation Phase-Participants received a single dose of CT7001 on Day1 of Cycle 0 (C0D1) followed by a 2-day washout period (C0D2), before receiving cycles of 21 continuous days dosing of CT7001capsules.Dosing was continued until the participant was no longer gaining clinical benefit or another treatment discontinuation criterion was met, at which time an end of treatment visit was conducted.
OG003
Module 1 Part A-Cohort 4 360mg OD
Dose Escalation Phase-Participants received a single dose ofCT7001 on Day1 of Cycle 0 (C0D1) followed by a 2-day washout period(C0D2), before receiving cycles of 21 continuous days dosing of CT7001capsules.Dosing was continued until the participant was no longer gaining clinical benefit or another treatment discontinuation criterion was met, at which time an end of treatment visit was conducted.
Once the MBAD was determined and agreed by the SRC, the paired biopsy expansion cohort inpatients with breast cancercommenced atthe selected dose
OG004
Module 1 Part A-Cohort 5 180mg BID
Dose Escalation Phase-Participants received twice daily dose of CT7001 on Day1 of Cycle 0(C0D1) followed by a 2-day washout period(C0D2), before receiving cycles of 21continuous days dosing of CT7001capsules.Dosing was continued until the participant was no longer gaining clinical benefit or another treatment discontinuation criterion was met, at which time an end of treatment visit was conducted.
OG005
Module 1 Part A Paired Biopsy Breast Cancer Expansion Cohort-240mg
Participants with locally advanced or metastatic breast cancer will receive CT7001(samuraciclib) as oral monotherapy at the minimally biologically active dose(MBAD) and recommended dose for Phase II testing(RP2D).
OG006
Module 1 Part A Paired Biopsy Breast Cancer Expansion Cohort-360mg
Participants with locally advanced or metastatic breast cancer will receive CT7001(samuraciclib) as oral monotherapy at the minimally biologically active dose(MBAD) and recommended dose for Phase II testing(RP2D).
OG007
Module 1 Part B-1 Triple-negative Breast Cancer (TNBC) Expansion
Participants with locally advanced or metastatic triple-negative breast cancer (TNBC) will receive CT7001(samuraciclib) as oral monotherapy at the dose, frequency and schedule recommended from Module 1 Part A.
CT7001: Cyclin-dependent kinase 7 (CDK7) inhibitor given orally once daily until disease progression
OG008
Module 1 Part B-2 Castrate Resistant Prostate Cancer (CRPC) Expansion
Participants with castrate resistant prostate cancer will receive CT7001(samuraciclib) as oral monotherapy at the dose, frequency and schedule recommended from Module 1 Part A.
CT7001: Cyclin-dependent kinase 7 (CDK7) inhibitor given orally once daily until disease progression
OG009
Module 2A 240 mg OD
Participants with locally advanced or metastatic HR+ve and HER2-ve breast cancer will receive CT7001 (samuraciclib) at the dose, frequency and schedule recommended from Module 1 part A and will receive Fulvestrant solution in pre-filled syringe for intramuscular (IM) injection
CT7001: Cyclin-dependent kinase 7 (CDK7) inhibitor given orally once daily until disease progression
Fulvestrant: Administered as 2 x 250mg intramuscular (IM) gluteal injections on Day 1, Day 15, Day 28 and every 28 days thereafter.
OG010
Module 2A 360 mg OD
Participants with locally advanced or metastatic HR+ve and HER2-ve breast cancer will receive CT7001 (samuraciclib) at the dose, frequency and schedule recommended from Module 1 part A and will receive Fulvestrant solution in pre-filled syringe for intramuscular (IM) injection
CT7001: Cyclin-dependent kinase 7 (CDK7) inhibitor given orally once daily until disease progression
Fulvestrant: Administered as 2 x 250mg intramuscular (IM) gluteal injections on Day 1, Day 15, Day 28 and every 28 days thereafter.
OG011
Module 4 120 mg OD Fed
Module 4 evaluated the effect of food on the PK of CT7001 using a randomized, balanced, single-dose, two-treatment (fed vs. fasting), two-period, two-sequence crossover design, followed by a continuous treatment phase.
Sequence 1:120 mg CT7001 fed in Period 1 followed by 120mg CT7001 fasted in Period 2. This was followed by 240mg OD continuous dosing.
OG012
Module 4 120mg OD Fasted
Module 4 evaluated the effect of food on the PK of CT7001 using a randomized, balanced, single-dose, two-treatment (fed vs. fasting), two-period, two-sequence cross overdesign, followed by a continuous treatment phase.
Sequence 2:120 mg CT7001 fasted in Period1 followed by 120 mg CT7001 fed in Period 2. This was followed by 240mg OD continuous dosing.
OG013
Module 4 360 mg OD Fed
Module 4 evaluated the effect of food on the PK of CT7001 using a randomized, balanced, single-dose, two-treatment (fed vs. fasting), two-period, two-sequence crossover design, followed by a continuous treatment phase.
Sequence 3: 360 mg CT7001 fed in Period 1 followed by 360mg CT7001 fasted in Period 2. This was followed by 360mg OD continuous dosing.
OG014
Module 4 360mg OD Fasted
Module 4 evaluated the effect of food on the PK ofCT7001 using a randomized, balanced, single-dose, two-treatment(fed vs. fasting),two-period, two-sequence crossover design, followed by a continuous treatment phase.
Sequence 4: 360 mg CT7001 fasted in Period1 followed by 360 mg CT7001 fed in Period 2. This was followed by 360 mg OD continuous dosing.
OG015
Module 4 240 mg OD Continuous Dosing
Module 4 evaluated the effect of food on the PK of CT7001 using a randomized, balanced, single-dose, two-treatment (fed vs. fasting), two-period, two-sequence crossover design, followed by a continuous treatment phase.
240mg OD continuous dosing (sequence 1 and 2 participants combined)
OG016
Module 4 360 mg OD Continuous Dosing
Module 4 evaluated the effect of food on the PK of CT7001 using a randomized, balanced, single-dose, two-treatment (fed vs. fasting), two-period, two-sequence crossover design, followed by a continuous treatment phase.
360mg OD continuous dosing (sequence 3 and 4 participants combined
Units
Counts
Participants
OG0006
OG0017
OG0026
OG003
Title
Denominators
Categories
Title
Measurements
OG0006
OG0017
OG0026
OG003
Secondary
Maximum Plasma Concentration of CT7001 (Cmax)
Cmax is the maximum observed plasma concentration of CT7001 following oral dosing.
Cmax presented for Module 1A cohorts 1-5 and Module 4 crossover cohorts. Module 1A paired biopsy cohorts (240mg OD and 360mg OD) results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results respectively and in accordance with pre-specified SAP.
Cmax was not required in accordance with pre-specified SAP for Module 1B-1, 1B-2, Module 2A and Module 4 continuous dose cohorts.
Posted
Geometric Mean
Geometric Coefficient of Variation
ng/mL
After the first dose and during the dosing period (from the time of dose administration to 24 hours) for Module 1A cohorts. Pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 24, 48, 72, 120 and 168 hours post dose for Module 4 Cohorts.
ID
Title
Description
OG000
Module 1 Part A-Cohort 1 120mg OD
Dose Escalation Phase-Participants received a single dose of CT7001 on Day1 of Cycle 0(C0D1) followed by a 2-day washout period(C0D2), before receiving cycles of 21 continuous days dosing ofCT7001 capsules. Dosing was continued until the participant was no longer gaining clinical benefit or another treatment discontinuation criterion was met, at which time an end of treatment visit was conducted.
OG001
Module 1 Part A-Cohort 2 240mg OD
Dose Escalation Phase- Participants received a single dose of CT7001 on Day1 of Cycle 0(C0D1) followed by a 2-day washout period (C0D2), before receiving cycles of 21 continuous days dosing of CT7001 capsules. Dosing was continued until the participant was no longer gaining clinical benefit or another treatment discontinuation criterion was met, at which time an end of treatment visit was conducted. Once the MBAD was determined and agreed by the SRC, the paired biopsy expansion cohort in patients with breast cancer commenced at the selected dose.
Secondary
Area Under the Curve (AUC)
Area under the plasma concentration-time curve representing the total drug exposure over time.
AUC presented for Module 1A cohorts 1-5 and Module 4 crossover cohorts. Module 1A paired biopsy cohorts (240mg OD and 360mg OD) results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results respectively and in accordance with pre-specified SAP.
AUC was not required in accordance with pre-specified SAP for Module 1B-1, 1B-2, Module 2A and Module 4 continuous dose cohorts.
Posted
Geometric Mean
Geometric Coefficient of Variation
h*ng/mL
After the first dose and during the dosing period (from the time of dose administration to 24 hours) for Module 1A. Pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 24, 48, 72, 120 and 168 hours post dose for Module 4 Cohorts.
ID
Title
Description
OG000
Module 1 Part A-Cohort 1 120mg OD
Dose Escalation Phase-Participants received a single dose of CT7001 on Day1 of Cycle 0(C0D1) followed by a 2-day washout period (C0D2), before receiving cycles of 21 continuous days dosing of CT7001capsules.Dosing was continued until the participant was no longer gaining clinical benefit or another treatment discontinuation criterion was met, at which time an end of treatment visit was conducted.
OG001
Module 1 Part A-Cohort 2 240mg OD
Dose Escalation Phase- Participants received a single dose of CT7001 on Day1 of Cycle 0(C0D1) followed by a 2-day washout period (C0D2), before receiving cycles of 21continuous days dosing of CT7001capsules. Dosing was continued until the participant was no longer gaining clinical benefit or another treatment discontinuation criterion was met, at which time an end of treatment visit was conducted. Once the MBAD was determined and agreed by the SRC, the paired biopsy expansion cohort in patients with breast cancer commenced at the selected dose.
Secondary
Mean Trough Plasma Pharmacokinetic Concentrations for CT7001
Mean Trough Plasma Pharmacokinetic Concentrations is the lowest concentration of a drug in the bloodstream during a dosing interval.
Timeframe: On study sampling: M1A - Day 1, 8, 15, 22, 29, 43, 50, every 21 days thereafter and EOT. M1B-1 and M1B-2: Day1, 8, 22, every 21 days thereafter and EOT. M2A: Day1, 15, 29, 57, every 56 days thereafter and EOT. M4: Day 1, 8, 15, 22, 29, 36, every 21 days thereafter and EOT.
Mean trough plasma PK concentration (CT7001) presented for Module 1A cohorts 1-5, Module 1 B-1, Module 1B-2, Module 2A 360mg & Module 4 (continuous dose) cohorts. M1A paired biopsy cohorts (240mg OD & 360mg OD) results are included within M1A cohort 2 (240mg OD) & cohort 4 (360mg OD) results respectively & in accordance with pre-specified SAP. M2A 240mg could not be calculated due to insufficient blood sample volume collected. M 4 crossover cohorts are not reported in accordance with the SAP.
Posted
Geometric Mean
Geometric Coefficient of Variation
ng/mL
From enrolment (Day 1) through to disease progression, unacceptable toxicity or withdrawal of consent, whichever came first (EOT). Assessed up to 1135 days. On study pre-dose sampling for all modules (see outcome measure description).
ID
Title
Description
OG000
Module 1 Part A-Cohort 1 120mg OD
Dose Escalation Phase-Participants received a single dose of CT7001 on Day 1 of Cycle 0 (C0D1) followed by a 2-day washout period (C0D2), before receiving cycles of 21 continuous days dosing of CT7001 capsules. Dosing was continued until the participant was no longer gaining clinical benefit or another treatment discontinuation criterion was met, at which time an end of treatment visit was conducted.
Secondary
Mean Trough Plasma Pharmacokinetic Concentrations for Fulvestrant (Module 2A)
Mean trough plasma PK concentrations refer to the lowest concentration of a drug in the bloodstream during a dosing interval.
Mean Trough Plasma Pharmacokinetic Concentration under this outcome measure are presented for Module 2A cohorts for fulvestrant.
Mean Trough Plasma Pharmacokinetic Concentration for CT7001 are presented for M1A 1-5 cohorts (including paired biopsy cohorts), M 1B-1, 1B-2, M 2A 360mg and M4 in a separate outcome measure under "Trough plasma concentration for CT7001".
Posted
Geometric Mean
Geometric Coefficient of Variation
ng/mL
From enrolment through to disease progression, unacceptable toxicity or withdrawal of consent, whichever came first (EOT). Pre-dose sampling at Day 1, 15, 29, 57 and every 56 days thereafter and EOT. Assessed up to 848 days.
ID
Title
Description
OG000
Module 2 Part A CT7001 240 mg OD + Fulvestrant (Cohort 1)
Participants with locally advanced or metastatic HR+ve and HER2-ve breast cancer will receive CT7001 (samuraciclib) at the dose, frequency and schedule recommended from Module 1 part A and will receive Fulvestrant solution in pre-filled syringe for intramuscular (IM) injection
CT7001: Cyclin-dependent kinase 7 (CDK7) inhibitor given orally once daily until disease progression
Fulvestrant: Administered as 2 x 250mg intramuscular (IM) gluteal injections on Day 1, Day 15, Day 28 and every 28 days thereafter.
OG001
Module 2 Part A CT7001 360 mg OD + Fulvestrant (Cohort 2)
Secondary
Anti-tumour Activity According to RECIST v1.1-Best Objective Response
Antitumour activity endpoints were analysed using the evaluable for Response population (any patient with at least one post baseline RECIST assessment).
Best objective response is defined as the best response recorded from the start of study treatment to the end of treatment, including any assessments for confirmation after the end of treatment. Percentage of participants with each response calculated was based on the total number of participants with a baseline RECIST assessment.
Timeframe: Scan frequency - Modules 1A and 4 (every 6 weeks); Modules 1B-1 and 2A (every 8 weeks first year, every 12 weeks thereafter); Module 1B-2 (every 8 weeks for the 6 months, every 12 weeks thereafter).
Best Objective Response (BOR) presented for Module 1A all cohorts, Module 1 B-1, Module 1B-2, Module 2A and Module 4 (continuous dose) cohorts. Module 4-120mg OD Fed, Module 4 120mg OD Fasted, Module 4 360mg OD Fed and Module 4 360mg OD Fasted are not reported as was pre-specified by the Statistical Analysis Plan. The BOR for these patients are reported under the continuous dosing results. Module 2A 360mg cohort has 19/25 patients in the evaluable for response population.
Posted
Number
participants
From enrolment (Day 1) until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 1135 days (162 weeks). Frequency in outcome measure description.
ID
Title
Description
OG000
Module 1 Part A-Cohort 1 120mg OD
Dose Escalation Phase-Participants received a single dose of CT7001 on Day1 of Cycle 0 (C0D1) followed by a 2-day washout period (C0D2), before receiving cycles of 21 continuous days dosing of CT7001capsules.Dosing was continued until the participant was no longer gaining clinical benefit or another treatment discontinuation criterion was met, at which time an end of treatment visit was conducted.
Secondary
Anti-tumour Activity According to RECIST v1.1-Progression Free Survival
Antitumour activity endpoints were analysed using the evaluable for Response population based on RECIST assessment.
Progression free survival is defined as the time from start of treatment until the date of objective disease progression or death (by any cause in the absence of progression) regardless of whether the participant had withdrawn from therapy or had received another anti-cancer therapy prior to progression. Participants who had not progressed or died at the time of analysis were censored at the time of the latest date of assessment from their last evaluable RECIST assessment.
PFS is presented for Modules 1B-1 and Module 2A cohorts. Following a review of the data, the PFS endpoint was deemed clinically non-informative for Module 1A, Module 1B-2 and Module 4 cohorts due to the limited number of patients in each module/cohort and was excluded from the final analysis.
Posted
Median
95% Confidence Interval
days
From enrolment (Day 1) until the date of first documented progression or date of death from any cause, whichever came first. Modules 1B-1 and 2A: every 8 weeks first year, every 12 weeks thereafter) assessed up to 848 days (121 weeks).
ID
Title
Description
OG000
Module 1 Part A-Cohort 1 120mg OD
Dose Escalation Phase-Participants received a single dose of CT7001 on Day 1 of Cycle 0 (C0D1) followed by a 2-day washout period (C0D2), before receiving cycles of 21 continuous days dosing of CT7001 capsules.
Dosing was continued until the participant was no longer gaining clinical benefit or another treatment discontinuation criterion was met, at which time an end of treatment visit was conducted
Secondary
Anti-tumour Activity According to RECIST v1.1-Clinical Benefit Rate (CBR)
Antitumour activity endpoints were analysed using the evaluable for Response population based on RECIST assessment.
Clinical Benefit Rate (CBR) is defined as the percentage of subjects with a confirmed objective response of complete response or partial response, or stabilisation of disease for at least 24 weeks.
Clinical Benefit Rate (CBR) is defined as the percentage of subjects with a confirmed objective response of complete response or partial response, or stabilisation of disease for at least 24 weeks CBR is analysed using the evaluable for response population (any patient with at least one post baseline RECIST assessment). CBR is presented Module 2A only. Modules 1A, 1B-1, 1B-2 and 4 were excluded from the final analysis due to the low number in evaluable for response population.
Posted
Number
percentage of subjects
From enrolment (Day 1) until the date of first documented progression or date of death from any cause, whichever came first. Module 2A: every 8 weeks first year, every 12 weeks thereafter) assessed up to 848 days (121 weeks).
ID
Title
Description
OG000
Module 1 Part A-Cohort 1 120mg OD
Dose Escalation Phase-Participants received a single dose of CT7001 on Day 1 of Cycle 0 (D0D1) followed by a 2-day washout period (C0D2), before receiving cycles of 21 continuous days dosing of CT7001 capsules.
Dosing was continued until the participant was not longer gaining clinical benefit or another treatment discontinuation criterion was met, at which time an end of treatment visit was conducted.
OG001
Time Frame
SAEs from consent, AEs from Day 1 to end of study (EOS). EOS (up to 35 days after EOT). EOT is date of first documented disease progression, unacceptable toxicity or withdrawal of consent, whichever came first. Assessed up to 1198 days.
Description
AEs and TEAEs from were summarized by MedDRA system organ class (SOC), preferred term (PT), and Common Terminology Criteria for Adverse Events (CTCAE) grade. SAEs events were analyzed and reported separately. Mortality data is deaths reported due to any cause. No deaths were assessed by the investigator as related to CT7001 treatment. Module 1A paired biopsy cohorts results are included within Module 1A cohort 2 (240mg OD) and cohort 4 (360mg OD) results in accordance with pre-specified SAP.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Module 1 Part A-Cohort 1 120mg OD
Dose Escalation Phase-Participants received a single dose of CT7001 on Day 1 of Cycle 0 (D0D1) followed by a 2-day washout period (C0D2), before receiving cycles of 21 continuous days dosing of CT7001 capsules. Dosing was continued until the participant was not longer gaining clinical benefit or another treatment discontinuation criterion was met, at which time an end of treatment visit was conducted.
1
6
1
6
6
6
EG001
Module 1 Part A-Cohort 2 240mg OD
Dose Escalation Phase- Participants received a single dose of CT7001 on Day 1 of Cycle 0 (D0D1) followed by a 2-day washout period (C0D2), before receiving cycles of 21 continuous days dosing of CT7001 capsules. Dosing was continued until the participant was not longer gaining clinical benefit or another treatment discontinuation criterion was met, at which time an end of treatment visit was conducted. Once the MBAD was determined and agreed by the SRC, the paired biopsy expansion cohort in patients with breast cancer commenced at the selected dose.
1
12
4
12
12
12
EG002
Module 1 Part A-Cohort 3 480mg OD
Dose Escalation Phase- Participants received a single dose of CT7001 on Day 1 of Cycle 0 (D0D1) followed by a 2-day washout period (C0D2), before receiving cycles of 21 continuous days dosing of CT7001 capsules. Dosing was continued until the participant was not longer gaining clinical benefit or another treatment discontinuation criterion was met, at which time an end of treatment visit was conducted.
0
6
1
6
6
6
EG003
Module 1 Part A-Cohort 4 360mg OD
Dose Escalation Phase- Participants received a single dose of CT7001 on Day 1 of Cycle 0 (D0D1) followed by a 2-day washout period (C0D2), before receiving cycles of 21 continuous days dosing of CT7001 capsules. Dosing was continued until the participant was not longer gaining clinical benefit or another treatment discontinuation criterion was met, at which time an end of treatment visit was conducted. Once the MBAD was determined and agreed by the SRC, the paired biopsy expansion cohort in patients with breast cancer commenced at the selected dose.
0
12
3
12
12
12
EG004
Module 1 Part A-Cohort 5 180mg BID
Dose Escalation Phase- Participants received a single dose of CT7001 on Day 1 of Cycle 0 (D0D1) followed by a 2-day washout period (C0D2), before receiving cycles of 21 continuous days dosing of CT7001 capsules. Dosing was continued until the participant was not longer gaining clinical benefit or another treatment discontinuation criterion was met, at which time an end of treatment visit was conducted.
0
8
3
8
8
8
EG005
Module 1 Part B-1 Triple-negative Breast Cancer (TNBC) Expansion
Dose Escalation Phase-Participants with locally advanced or metastatic triple-negative breast cancer (TNBC) will receive CT7001(samuraciclib) as oral monotherapy at the dose, frequency and schedule recommended from Module 1 Part A.
CT7001: Cyclin-dependent kinase 7 (CDK7) inhibitor given orally once daily until disease progression
2
23
9
23
23
23
EG006
Module 1 Part B-2 Castrate Resistant Prostate Cancer (CRPC) Expansion
Participants with castrate resistant prostate cancer will receive CT7001(samuraciclib) as oral monotherapy at the dose, frequency and schedule recommended from Module 1 Part A.
CT7001: Cyclin-dependent kinase 7 (CDK7) inhibitor given orally once daily until disease progression
0
11
2
11
11
11
EG007
Module 2 Part A CT7001 240mg OD + Fulvestrant (Cohort 1)
Participants with locally advanced or metastatic HR+ve and HER2-ve breast cancer will receive CT7001 (samuraciclib) at the dose, frequency and schedule recommended from Module 1 part A and will receive Fulvestrant solution in pre-filled syringe for intramuscular (IM) injection CT7001: Cyclin-dependent kinase 7 (CDK7) inhibitor given orally once daily until disease progression Fulvestrant: Administered as 2 x 250mg intramuscular (IM) gluteal injections on Day 1, Day 15, Day 28 and every 28 days thereafter.
0
6
2
6
6
6
EG008
Module 2 Part A CT7001 360mg OD + Fulvestrant (Cohort 2)
Participants with locally advanced or metastatic HR+ve and HER2-ve breast cancer will receive CT7001 (samuraciclib) at the dose, frequency and schedule recommended from Module 1 part A and will receive Fulvestrant solution in pre-filled syringe for intramuscular (IM) injection CT7001: Cyclin-dependent kinase 7 (CDK7) inhibitor given orally once daily until disease progression Fulvestrant: Administered as 2 x 250mg intramuscular (IM) gluteal injections on Day 1, Day 15, Day 28 and every 28 days thereafter.
1
25
8
25
25
25
EG009
Module 4 120mg OD Fed
Module 4 evaluated the effect of food on the PK of CT7001using a randomized, balanced, single-dose, two-treatment (fed vs. fasting), two-period, two-sequence crossover design, followed by a continuous treatment phase. 120mg fed data combined and presented for Sequence 1, Period 1 and Sequence 2, Period 2.
0
6
0
6
2
6
EG010
Module 4 120mg OD Fasted
Module 4 evaluated the effect of food on the PK of CT7001using a randomized, balanced, single-dose, two-treatment (fed vs. fasting), two-period, two-sequence crossover design, followed by a continuous treatment phase. 120mg fasted data combined and presented for Sequence 1, Period 2 and Sequence 2, Period 1.
0
8
0
8
7
8
EG011
Module 4 360mg OD Fed
Module 4 evaluated the effect of food on the PK of CT7001using a randomized, balanced, single-dose, two-treatment (fed vs. fasting), two-period, two-sequence crossover design, followed by a continuous treatment phase. 360mg fed data combined and presented for Sequence 3, Period 1 and Sequence 4, Period 2.
0
7
0
7
5
7
EG012
Module 4 360mg OD Fasted
Module 4 evaluated the effect of food on the PK of CT7001using a randomized, balanced, single-dose, two-treatment (fed vs. fasting), two-period, two-sequence crossover design, followed by a continuous treatment phase. 360mg fasted data combined and presented for Sequence 3, Period 2 and Sequence 4, Period 1.
0
7
0
7
5
7
EG013
Module 4 240mg OD Continuous Dosing
Module 4 evaluated the effect of food on the PK of CT7001using a randomized, balanced, single-dose, two-treatment (fed vs. fasting), two-period, two-sequence crossover design, followed by a continuous treatment phase. 240mg OD continuous dosing data combined and presented for Sequence 1 and Sequence 2 participants.
0
8
0
8
8
8
EG014
Module 4 360mg OD Continous Dosing
Module 4 evaluated the effect of food on the PK of CT7001using a randomized, balanced, single-dose, two-treatment (fed vs. fasting), two-period, two-sequence crossover design, followed by a continuous treatment phase. 360mg OD continuous dosing data combined and presented for Sequence 3 and Sequence 4 participants.
1
7
4
7
7
7
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected12 at risk
EG0020 affected6 at risk
EG0030 affected12 at risk
EG0040 affected8 at risk
EG0051 affected23 at risk
EG0060 affected11 at risk
EG0070 affected6 at risk
EG0080 affected25 at risk
EG0090 affected6 at risk
EG0100 affected8 at risk
EG0110 affected7 at risk
EG0120 affected7 at risk
EG0130 affected8 at risk
EG0140 affected7 at risk
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected12 at risk
EG0020 affected6 at risk
EG003
Atrial flutter
Cardiac disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected12 at risk
EG0020 affected6 at risk
EG003
Retinal detachment
Eye disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected12 at risk
EG0020 affected6 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected12 at risk
EG0020 affected6 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected12 at risk
EG0020 affected6 at risk
EG003
Diaphragmatic hernia
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected12 at risk
EG0020 affected6 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected12 at risk
EG0020 affected6 at risk
EG003
Gastroesophageal reflux disease
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected12 at risk
EG0020 affected6 at risk
EG003
Intra-abdominal haemorrhage
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected12 at risk
EG0020 affected6 at risk
EG003
Large intestine perforation
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected12 at risk
EG0020 affected6 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected12 at risk
EG0020 affected6 at risk
EG003
Oesophagitis
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected12 at risk
EG0020 affected6 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected12 at risk
EG0020 affected6 at risk
EG003
Disease progression
General disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected12 at risk
EG0020 affected6 at risk
EG003
Pyrexia
General disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected12 at risk
EG0020 affected6 at risk
EG003
Cholecystitis
Hepatobiliary disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected12 at risk
EG0020 affected6 at risk
EG003
Liver injury
Hepatobiliary disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected12 at risk
EG0020 affected6 at risk
EG003
Appendicitis
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected12 at risk
EG0020 affected6 at risk
EG003
Atypical pneumonia
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected12 at risk
EG0020 affected6 at risk
EG003
Bronchitis
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0001 affected6 at risk
EG0010 affected12 at risk
EG0020 affected6 at risk
EG003
COVID-19
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected12 at risk
EG0020 affected6 at risk
EG003
COVID-19 pneumonia
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected12 at risk
EG0020 affected6 at risk
EG003
Gastroenteritis viral
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected12 at risk
EG0020 affected6 at risk
EG003
Lower respiratory tract infection
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected12 at risk
EG0020 affected6 at risk
EG003
Parainfluenzae virus infection
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected12 at risk
EG0020 affected6 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected12 at risk
EG0020 affected6 at risk
EG003
Skin infection
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected12 at risk
EG0020 affected6 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected12 at risk
EG0020 affected6 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected12 at risk
EG0020 affected6 at risk
EG003
Vascular graft occlusion
Injury, poisoning and procedural complications
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected12 at risk
EG0020 affected6 at risk
EG003
Electrocardiogram QT prolonged
Investigations
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected12 at risk
EG0020 affected6 at risk
EG003
Acidosis
Metabolism and nutrition disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected12 at risk
EG0020 affected6 at risk
EG003
Hypercalcaemia
Metabolism and nutrition disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected12 at risk
EG0020 affected6 at risk
EG003
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected12 at risk
EG0020 affected6 at risk
EG003
Lung neoplasm malignant
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected12 at risk
EG0020 affected6 at risk
EG003
Malignant neoplasm progression
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.0
Systematic Assessment
EG0001 affected6 at risk
EG0011 affected12 at risk
EG0020 affected6 at risk
EG003
Metastases to central nervous system
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected12 at risk
EG0020 affected6 at risk
EG003
Cerebral haemorrhage
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected12 at risk
EG0020 affected6 at risk
EG003
Posterior reversible encephalopathy syndrome
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected12 at risk
EG0020 affected6 at risk
EG003
Presyncope
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected12 at risk
EG0020 affected6 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected12 at risk
EG0020 affected6 at risk
EG003
Acute kidney injury
Renal and urinary disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected12 at risk
EG0020 affected6 at risk
EG003
Diaphragm muscle weakness
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected12 at risk
EG0020 affected6 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0001 affected6 at risk
EG0010 affected12 at risk
EG0020 affected6 at risk
EG003
Dyspnoea at rest
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected12 at risk
EG0020 affected6 at risk
EG003
Hypoxia
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected12 at risk
EG0020 affected6 at risk
EG003
Lung disorder
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0001 affected6 at risk
EG0010 affected12 at risk
EG0020 affected6 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected12 at risk
EG0020 affected6 at risk
EG003
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected12 at risk
EG0021 affected6 at risk
EG003
Hypotension
Vascular disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected12 at risk
EG0020 affected6 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA 23.0
Systematic Assessment
EG0001 affected6 at risk
EG0015 affected12 at risk
EG0021 affected6 at risk
EG0032 affected12 at risk
EG0041 affected8 at risk
EG0051 affected23 at risk
EG0063 affected11 at risk
EG0071 affected6 at risk
EG0083 affected25 at risk
EG0090 affected6 at risk
EG0100 affected8 at risk
EG0110 affected7 at risk
EG0120 affected7 at risk
EG0130 affected8 at risk
EG0141 affected7 at risk
Leukopenia
Blood and lymphatic system disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected12 at risk
EG0020 affected6 at risk
EG003
Lymphadenopathy
Blood and lymphatic system disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected12 at risk
EG0020 affected6 at risk
EG003
Lymphopenia
Blood and lymphatic system disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected12 at risk
EG0020 affected6 at risk
EG003
Neutropenia
Blood and lymphatic system disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected12 at risk
EG0020 affected6 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected12 at risk
EG0020 affected6 at risk
EG003
Atrial flutter
Cardiac disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected12 at risk
EG0020 affected6 at risk
EG003
Atrioventricular block first degree
Cardiac disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected12 at risk
EG0020 affected6 at risk
EG003
Cardiac failure
Cardiac disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected12 at risk
EG0020 affected6 at risk
EG003
Pericardial effusion
Cardiac disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected12 at risk
EG0021 affected6 at risk
EG003
Sinus bradycardia
Cardiac disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected12 at risk
EG0020 affected6 at risk
EG003
Sinus tachycardia
Cardiac disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected12 at risk
EG0020 affected6 at risk
EG003
Hypoacusis
Ear and labyrinth disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected12 at risk
EG0020 affected6 at risk
EG003
Diplopia
Eye disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected12 at risk
EG0020 affected6 at risk
EG003
Eye pain
Eye disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected12 at risk
EG0020 affected6 at risk
EG003
Vision blurred
Eye disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected12 at risk
EG0020 affected6 at risk
EG003
Visual impairment
Eye disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected12 at risk
EG0020 affected6 at risk
EG003
Abdominal discomfort
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0001 affected6 at risk
EG0010 affected12 at risk
EG0020 affected6 at risk
EG003
Abdominal distension
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected12 at risk
EG0020 affected6 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0003 affected6 at risk
EG0011 affected12 at risk
EG0022 affected6 at risk
EG003
Abdominal pain lower
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected12 at risk
EG0020 affected6 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0001 affected6 at risk
EG0011 affected12 at risk
EG0021 affected6 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0013 affected12 at risk
EG0020 affected6 at risk
EG003
Dental caries
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected12 at risk
EG0020 affected6 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0006 affected6 at risk
EG0018 affected12 at risk
EG0026 affected6 at risk
EG003
Dry mouth
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected12 at risk
EG0020 affected6 at risk
EG003
Duodenogastric reflux
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected12 at risk
EG0020 affected6 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0001 affected6 at risk
EG0012 affected12 at risk
EG0020 affected6 at risk
EG003
Dysphagia
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected12 at risk
EG0020 affected6 at risk
EG003
Epigastric discomfort
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected12 at risk
EG0020 affected6 at risk
EG003
Faeces pale
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected12 at risk
EG0020 affected6 at risk
EG003
Flatulence
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected12 at risk
EG0020 affected6 at risk
EG003
Frequent bowel movements
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected12 at risk
EG0020 affected6 at risk
EG003
Gastritis
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected12 at risk
EG0020 affected6 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected12 at risk
EG0020 affected6 at risk
EG003
Haemorrhoids
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected12 at risk
EG0020 affected6 at risk
EG003
Hyperaesthesia teeth
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected12 at risk
EG0020 affected6 at risk
EG003
Hypoaesthesia
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected12 at risk
EG0020 affected6 at risk
EG003
Hypoaesthesia oral
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected12 at risk
EG0020 affected6 at risk
EG003
Inguinal hernia
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected12 at risk
EG0020 affected6 at risk
EG003
Irritable bowel syndrome
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected12 at risk
EG0020 affected6 at risk
EG003
Lip blister
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected12 at risk
EG0020 affected6 at risk
EG003
Lip ulceration
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected12 at risk
EG0020 affected6 at risk
EG003
Mouth ulceration
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0001 affected6 at risk
EG0011 affected12 at risk
EG0021 affected6 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0005 affected6 at risk
EG0019 affected12 at risk
EG0023 affected6 at risk
EG003
Oral pain
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected12 at risk
EG0020 affected6 at risk
EG003
Paraesthesia oral
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected12 at risk
EG0020 affected6 at risk
EG003
Rectal haemorrhage
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected12 at risk
EG0020 affected6 at risk
EG003
Retching
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected12 at risk
EG0020 affected6 at risk
EG003
Stomatitis
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected12 at risk
EG0021 affected6 at risk
EG003
Toothache
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected12 at risk
EG0020 affected6 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0004 affected6 at risk
EG0019 affected12 at risk
EG0026 affected6 at risk
EG003
Biliary tract infection
General disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected12 at risk
EG0020 affected6 at risk
EG003
Chills
General disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected12 at risk
EG0020 affected6 at risk
EG003
Crepitations
General disorders
MedDRA 23.0
Systematic Assessment
EG0001 affected6 at risk
EG0010 affected12 at risk
EG0020 affected6 at risk
EG003
Disease progression
General disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected12 at risk
EG0020 affected6 at risk
EG003
Facial pain
General disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected12 at risk
EG0020 affected6 at risk
EG003
Fatigue
General disorders
MedDRA 23.0
Systematic Assessment
EG0002 affected6 at risk
EG0017 affected12 at risk
EG0020 affected6 at risk
EG003
Influenza like illness
General disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected12 at risk
EG0020 affected6 at risk
EG003
Injection site brusing
General disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected12 at risk
EG0020 affected6 at risk
EG003
Mucosal inflammation
General disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected12 at risk
EG0020 affected6 at risk
EG003
Non-cardiac chest pain
General disorders
MedDRA 23.0
Systematic Assessment
EG0001 affected6 at risk
EG0010 affected12 at risk
EG0020 affected6 at risk
EG003
Oedema peripheral
General disorders
MedDRA 23.0
Systematic Assessment
EG0001 affected6 at risk
EG0010 affected12 at risk
EG0020 affected6 at risk
EG003
Pain
General disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected12 at risk
EG0020 affected6 at risk
EG003
Pyrexia
General disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected12 at risk
EG0020 affected6 at risk
EG003
Jaundice
Hepatobiliary disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected12 at risk
EG0020 affected6 at risk
EG003
Hypersensitivity
Immune system disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected12 at risk
EG0020 affected6 at risk
EG003
Prothrombin time prolonged
Investigations
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected12 at risk
EG0020 affected6 at risk
EG003
Seasonal allergy
Immune system disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected12 at risk
EG0020 affected6 at risk
EG003
Atypical pneumonia
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected12 at risk
EG0020 affected6 at risk
EG003
Biliary sepsis
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected12 at risk
EG0020 affected6 at risk
EG003
Bronchitis
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0001 affected6 at risk
EG0010 affected12 at risk
EG0020 affected6 at risk
EG003
Device related infection
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected12 at risk
EG0020 affected6 at risk
EG003
Fungal infection
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0001 affected6 at risk
EG0010 affected12 at risk
EG0020 affected6 at risk
EG003
Herpes zoster
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected12 at risk
EG0020 affected6 at risk
EG003
Hordeolum
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected12 at risk
EG0020 affected6 at risk
EG003
Influenza
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected12 at risk
EG0020 affected6 at risk
EG003
Laryngitis
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected12 at risk
EG0020 affected6 at risk
EG003
Liver abscess
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected12 at risk
EG0020 affected6 at risk
EG003
Lower respiratory tract infection
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected12 at risk
EG0020 affected6 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected12 at risk
EG0020 affected6 at risk
EG003
Oral candidiasis
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected12 at risk
EG0020 affected6 at risk
EG003
Oral herpes
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected12 at risk
EG0020 affected6 at risk
EG003
Respiratory tract infection
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected12 at risk
EG0020 affected6 at risk
EG003
Rhinitis
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected12 at risk
EG0020 affected6 at risk
EG003
Tooth infection
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected12 at risk
EG0020 affected6 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected12 at risk
EG0021 affected6 at risk
EG003
Vulvovaginal candidiasis
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected12 at risk
EG0020 affected6 at risk
EG003
Wound infection
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected12 at risk
EG0020 affected6 at risk
EG003
Burn oral cavity
Injury, poisoning and procedural complications
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected12 at risk
EG0020 affected6 at risk
EG003
Clavicle fracture
Injury, poisoning and procedural complications
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected12 at risk
EG0020 affected6 at risk
EG003
Contusion
Injury, poisoning and procedural complications
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected12 at risk
EG0020 affected6 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA 23.0
Systematic Assessment
EG0002 affected6 at risk
EG0010 affected12 at risk
EG0020 affected6 at risk
EG003
Multiple fractures
Injury, poisoning and procedural complications
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected12 at risk
EG0020 affected6 at risk
EG003
Rib fracture
Injury, poisoning and procedural complications
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected12 at risk
EG0020 affected6 at risk
EG003
Sunburn
Injury, poisoning and procedural complications
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected12 at risk
EG0020 affected6 at risk
EG003
Thermal burn
Injury, poisoning and procedural complications
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected12 at risk
EG0021 affected6 at risk
EG003
Activated partial thromboplastin time prolonged
Investigations
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected12 at risk
EG0020 affected6 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA 23.0
Systematic Assessment
EG0001 affected6 at risk
EG0011 affected12 at risk
EG0021 affected6 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA 23.0
Systematic Assessment
EG0001 affected6 at risk
EG0011 affected12 at risk
EG0022 affected6 at risk
EG003
Blood alkaline phosphatase increased
Investigations
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected12 at risk
EG0020 affected6 at risk
EG003
Blood bilirubin increased
Investigations
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected12 at risk
EG0020 affected6 at risk
EG003
Blood creatinine increased
Investigations
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected12 at risk
EG0020 affected6 at risk
EG003
Blood creatinine phosphokinase increased
Investigations
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected12 at risk
EG0020 affected6 at risk
EG003
Blood glucose increased
Investigations
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected12 at risk
EG0020 affected6 at risk
EG003
Blood urea increased
Investigations
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected12 at risk
EG0020 affected6 at risk
EG003
Body temperature increased
Investigations
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected12 at risk
EG0020 affected6 at risk
EG003
Electrocardiogram QT prolonged
Investigations
MedDRA 23.0
Systematic Assessment
EG0001 affected6 at risk
EG0012 affected12 at risk
EG0020 affected6 at risk
EG003
Gamma-glutamyltransferase increased
Investigations
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected12 at risk
EG0020 affected6 at risk
EG003
Hyperphosphataemia
Investigations
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected12 at risk
EG0020 affected6 at risk
EG003
Liver function test abnormal
Investigations
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected12 at risk
EG0020 affected6 at risk
EG003
Neutrophil count decreased
Investigations
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected12 at risk
EG0020 affected6 at risk
EG003
Platelet count decreased
Investigations
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected12 at risk
EG0020 affected6 at risk
EG003
Weight decreased
Investigations
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected12 at risk
EG0020 affected6 at risk
EG003
White blood cell count decreased
Investigations
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected12 at risk
EG0020 affected6 at risk
EG003
Cachexia
Metabolism and nutrition disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected12 at risk
EG0020 affected6 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA 23.0
Systematic Assessment
EG0001 affected6 at risk
EG0012 affected12 at risk
EG0021 affected6 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected12 at risk
EG0020 affected6 at risk
EG003
Diabetes mellitus
Metabolism and nutrition disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected12 at risk
EG0020 affected6 at risk
EG003
Diabetes mellitus inadequate control
Metabolism and nutrition disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected12 at risk
EG0020 affected6 at risk
EG003
Hypercalcaemia
Metabolism and nutrition disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected12 at risk
EG0020 affected6 at risk
EG003
Hyperglycemia
Metabolism and nutrition disorders
MedDRA 23.0
Systematic Assessment
EG0001 affected6 at risk
EG0010 affected12 at risk
EG0020 affected6 at risk
EG003
Hypoalbuminaemia
Metabolism and nutrition disorders
MedDRA 23.0
Systematic Assessment
EG0001 affected6 at risk
EG0010 affected12 at risk
EG0020 affected6 at risk
EG003
Hypocalcaemia
Metabolism and nutrition disorders
MedDRA 23.0
Systematic Assessment
EG0001 affected6 at risk
EG0010 affected12 at risk
EG0020 affected6 at risk
EG003
Hypoglycaemia
Metabolism and nutrition disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected12 at risk
EG0020 affected6 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected12 at risk
EG0020 affected6 at risk
EG003
Hypomagnesaemia
Metabolism and nutrition disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected12 at risk
EG0020 affected6 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected12 at risk
EG0020 affected6 at risk
EG003
Hypophosphataemia
Metabolism and nutrition disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected12 at risk
EG0020 affected6 at risk
EG003
Magnesium deficiency
Metabolism and nutrition disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected12 at risk
EG0020 affected6 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected12 at risk
EG0021 affected6 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0002 affected6 at risk
EG0012 affected12 at risk
EG0020 affected6 at risk
EG003
Bone pain
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected12 at risk
EG0020 affected6 at risk
EG003
Chest pain
General disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected12 at risk
EG0020 affected6 at risk
EG003
Flank pain
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected12 at risk
EG0020 affected6 at risk
EG003
Groin pain
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected12 at risk
EG0020 affected6 at risk
EG003
Joint swelling
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected12 at risk
EG0020 affected6 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected12 at risk
EG0020 affected6 at risk
EG003
Muscular weakness
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected12 at risk
EG0020 affected6 at risk
EG003
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0001 affected6 at risk
EG0011 affected12 at risk
EG0020 affected6 at risk
EG003
Musculoskeletal discomfort
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected12 at risk
EG0020 affected6 at risk
EG003
Musculoskeletal pain
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected12 at risk
EG0020 affected6 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected12 at risk
EG0020 affected6 at risk
EG003
Neck pain
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected12 at risk
EG0020 affected6 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected12 at risk
EG0020 affected6 at risk
EG003
Pain in jaw
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected12 at risk
EG0020 affected6 at risk
EG003
Breast cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected12 at risk
EG0020 affected6 at risk
EG003
Metastases to central nervous system
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected12 at risk
EG0021 affected6 at risk
EG003
Ageusia
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected12 at risk
EG0020 affected6 at risk
EG003
Dizziness
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected12 at risk
EG0020 affected6 at risk
EG003
Dysarthria
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected12 at risk
EG0020 affected6 at risk
EG003
Dysgeusia
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected12 at risk
EG0020 affected6 at risk
EG003
Dyskinesia
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected12 at risk
EG0020 affected6 at risk
EG003
Headache
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected12 at risk
EG0022 affected6 at risk
EG003
Intention tremor
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected12 at risk
EG0020 affected6 at risk
EG003
Lethargy
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected12 at risk
EG0020 affected6 at risk
EG003
Neuralgia
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0001 affected6 at risk
EG0010 affected12 at risk
EG0020 affected6 at risk
EG003
Neuropathy peripheral
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected12 at risk
EG0020 affected6 at risk
EG003
Nystagmus
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected12 at risk
EG0020 affected6 at risk
EG003
Paraesthesia
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected12 at risk
EG0020 affected6 at risk
EG003
Peripheral motor neuropathy
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected12 at risk
EG0020 affected6 at risk
EG003
Syncope
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected12 at risk
EG0020 affected6 at risk
EG003
Taste disorder
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected12 at risk
EG0020 affected6 at risk
EG003
Tremor
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected12 at risk
EG0020 affected6 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected12 at risk
EG0020 affected6 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected12 at risk
EG0020 affected6 at risk
EG003
Acute kidney injury
Renal and urinary disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected12 at risk
EG0020 affected6 at risk
EG003
Chronic kidney disease
Renal and urinary disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected12 at risk
EG0020 affected6 at risk
EG003
Dysuria
Renal and urinary disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected12 at risk
EG0020 affected6 at risk
EG003
Glycosuria
Renal and urinary disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected12 at risk
EG0020 affected6 at risk
EG003
Haematuria
Renal and urinary disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected12 at risk
EG0020 affected6 at risk
EG003
Urinary incontinence
Renal and urinary disorders
MedDRA 23.0
Systematic Assessment
EG0001 affected6 at risk
EG0010 affected12 at risk
EG0020 affected6 at risk
EG003
Breast discomfort
Reproductive system and breast disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected12 at risk
EG0020 affected6 at risk
EG003
Pelvic pain
Reproductive system and breast disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected12 at risk
EG0020 affected6 at risk
EG003
Priapism
Reproductive system and breast disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected12 at risk
EG0020 affected6 at risk
EG003
Vaginal haemorrhage
Reproductive system and breast disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected12 at risk
EG0020 affected6 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0001 affected6 at risk
EG0014 affected12 at risk
EG0020 affected6 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0002 affected6 at risk
EG0011 affected12 at risk
EG0021 affected6 at risk
EG003
Dyspnoea exertional
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected12 at risk
EG0020 affected6 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected12 at risk
EG0020 affected6 at risk
EG003
Haemoptysis
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected12 at risk
EG0020 affected6 at risk
EG003
Increased viscosity of upper respiratory secretion
Hormones, Hormone Substitutes, and Hormone Antagonists
Browse Leaves
Not provided
Browse Branches
Not provided
0
BG0040
BG0050
BG0060
BG0070
BG0080
BG0090
BG0100
BG0110
BG0120
BG0130
BG0140
BG0150
Between 18 and 65 years
BG0005
BG0014
BG0026
BG0033
BG0044
BG0053
BG0064
BG00719
BG0085
BG0095
BG01015
BG0111
BG0122
BG0132
BG0141
BG01579
>=65 years
BG0001
BG0013
BG0020
BG0033
BG0044
BG0052
BG0062
BG0074
BG0086
BG0091
BG01010
BG0113
BG0122
BG0132
BG0142
BG01545
6
BG0033
BG0046
BG0055
BG0066
BG00723
BG0080
BG0096
BG01025
BG0110
BG0122
BG0132
BG0141
BG01591
Male
BG0002
BG0015
BG0020
BG0033
BG0042
BG0050
BG0060
BG0070
BG00811
BG0090
BG0100
BG0114
BG0122
BG0132
BG0142
BG01533
0
BG0030
BG0040
BG0050
BG0060
BG0070
BG0080
BG0090
BG0102
BG0110
BG0120
BG0130
BG0140
BG0152
Not Hispanic or Latino
BG0004
BG0015
BG0026
BG0036
BG0048
BG0055
BG0065
BG00718
BG0086
BG0095
BG01021
BG0114
BG0124
BG0132
BG0143
BG015102
Unknown or Not Reported
BG0002
BG0012
BG0020
BG0030
BG0040
BG0050
BG0061
BG0075
BG0085
BG0091
BG0102
BG0110
BG0120
BG0132
BG0140
BG01520
0
BG0030
BG0040
BG0050
BG0060
BG0070
BG0080
BG0090
BG0100
BG0110
BG0120
BG0130
BG0140
BG0150
Asian
BG0002
BG0010
BG0020
BG0030
BG0041
BG0050
BG0060
BG0070
BG0080
BG0090
BG0102
BG0110
BG0120
BG0130
BG0140
BG0155
Native Hawaiian or Other Pacific Islander
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
BG0070
BG0080
BG0090
BG0100
BG0110
BG0120
BG0130
BG0140
BG0150
Black or African American
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
BG0070
BG0080
BG0090
BG0102
BG0110
BG0120
BG0130
BG0140
BG0152
White
BG0004
BG0015
BG0026
BG0036
BG0047
BG0055
BG0066
BG00719
BG0088
BG0096
BG01020
BG0114
BG0124
BG0134
BG0143
BG015107
More than one race
BG0000
BG0012
BG0020
BG0030
BG0040
BG0050
BG0060
BG0074
BG0083
BG0090
BG0101
BG0110
BG0120
BG0130
BG0140
BG01510
Unknown or Not Reported
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
BG0070
BG0080
BG0090
BG0100
BG0110
BG0120
BG0130
BG0140
BG0150
0
BG0030
BG0040
BG0050
BG0060
BG0070
BG0080
BG0091
BG01012
BG0110
BG0120
BG0130
BG0140
BG01513
United Kingdom
Title
Measurements
BG0006
BG0017
BG0026
BG0036
BG0048
BG0055
BG0066
BG00723
BG00811
BG0095
BG01013
BG0114
BG0124
BG0134
BG0143
BG015111
6
OG0048
OG0055
OG0066
OG00723
OG00811
OG0096
OG01025
OG0116
OG0128
OG0137
OG0147
OG0158
OG0167
6
OG0048
OG0055
OG0066
OG00722
OG00811
OG0096
OG01024
OG0110
OG0125
OG0135
OG0144
OG0158
OG0167
OG002
Module 1 Part A-Cohort 3 480 mg OD
Dose Escalation Phase-Participants received a single dose of CT7001 on Day1 of Cycle 0 (C0D1) followed by a 2-day washout period (C0D2), before receiving cycles of 21 continuous days dosing of CT7001 capsules. Dosing was continued until the participant was no longer gaining clinical benefit or another treatment discontinuation criterion was met, at which time an end of treatment visit was conducted.
OG003
Module 1 Part A-Cohort 4 360mg OD
Dose Escalation Phase-Participants received a single dose of CT7001 on Day1 of Cycle 0 (C0D1) followed by a 2-day washout period(C0D2), before receiving cycles of 21 continuous days dosing of CT7001 capsules. Dosing was continued until the participant was no longer gaining clinical benefit or another treatment discontinuation criterion was met, at which time an end of treatment visit was conducted.
Once the MBAD was determined and agreed by the SRC, the paired biopsy expansion cohort inpatients with breast cancer commenced at the selected dose.
OG004
Module 1 Part A-Cohort 5 180mg BID
Dose Escalation Phase-Participants received twice daily dose of CT7001 on Day1 of Cycle 0(C0D1) followed by a 2-day washout period (C0D2), before receiving cycles of 21 continuous days dosing of CT7001capsules.Dosing was continued until the participant was no longer gaining clinical benefit or another treatment discontinuation criterion was met, at which time an end of treatment visit was conducted.
OG005
Module 4 120 mg OD Fed
Participants with advanced solid tumours will receive CT7001 (samuraciclib) oral monotherapy in a randomized, balanced, single-dose, two-treatment (fed v fasting), two-period, two-sequence crossover study followed by once daily continuous dosing.
CT7001: Cyclin-dependent kinase 7 (CDK7) inhibitor given orally once daily until disease progression
OG006
Module 4 120 mg OD Fasted
Participants with advanced solid tumours will receive CT7001(samuraciclib) oral monotherapy in a randomized, balanced, single-dose, two-treatment (fed v fasting), two-period, two-sequence crossover study followed by once daily continuous dosing.
CT7001: Cyclin-dependent kinase 7 (CDK7) inhibitor given orally once daily until disease progression
OG007
Module 4 360 mg OD Fed
Participants with advanced solid tumours will receive CT7001 (samuraciclib) oral monotherapy in a randomized, balanced, single-dose, two-treatment (fed v fasting), two-period, two-sequence crossover study followed by once daily continuous dosing.
CT7001: Cyclin-dependent kinase 7 (CDK7) inhibitor given orally once daily until disease progression
OG008
Module 4 360 mg OD Fasted
Participants with advanced solid tumours will receive CT7001 (samuraciclib) oral monotherapy in a randomized, balanced, single-dose, two-treatment (fed v fasting), two-period, two-sequence crossover study followed by once daily continuous dosing.
CT7001: Cyclin-dependent kinase 7 (CDK7) inhibitor given orally once daily until disease progression
Units
Counts
Participants
OG0005
OG0019
OG0021
OG0038
OG0043
OG0056
OG0068
OG0076
OG0087
Title
Denominators
Categories
Title
Measurements
OG00089.15± 106.9
OG001201.4± 22.25
OG002172.8± NA"NA" indicates that data could not be evaluated due to smaller number of participants.
OG003270.2± 45.69
OG004233.3± 28.75
OG00519.21± 149.1
OG00663.77± 108.8
OG007138.8± 19.72
OG008176.1± 63.91
OG002
Module 1 Part A-Cohort 3 480 mg OD
Dose Escalation Phase-Participants received a single dose of CT7001 on Day1 of Cycle 0 (C0D1) followed by a 2-day washout period(C0D2), before receiving cycles of 21 continuous days dosing of CT7001 capsules. Dosing was continued until the participant was no longer gaining clinical benefit or another treatment discontinuation criterion was met, at which time an end of treatment visit was conducted.
OG003
Module 1 Part A-Cohort 4 360mg OD
Dose Escalation Phase-Participants received a single dose of CT7001 on Day1 of Cycle 0 (C0D1) followed by a 2-day washout period(C0D2), before receiving cycles of 21 continuous days dosing of CT7001capsules.Dosing was continued until the participant was no longer gaining clinical benefit or another treatment discontinuation criterion was met, at which time an end of treatment visit was conducted.
Once the MBAD was determined and agreed by the SRC, the paired biopsy expansion cohort inpatients with breast cancer commenced at the selected dose.
OG004
Module 1 Part A-Cohort 5 180mg BID
Dose Escalation Phase-Participants received twice daily dose of CT7001 on Day1 of Cycle 0(C0D1) followed by a 2-day washout period(C0D2), before receiving cycles of 21continuous days dosing of CT7001 capsules. Dosing was continued until the participant was no longer gaining clinical benefit or another treatment discontinuation criterion was met, at which time an end of treatment visit was conducted.
OG005
Module 4-120 mg OD Fed
Participants with advanced solid tumours will receive CT7001(samuraciclib) oral monotherapy in a randomized, balanced, single-dose, two-treatment (fed v fasting), two-period, two-sequence crossover study followed by once daily continuous dosing.
CT7001: Cyclin-dependent kinase 7 (CDK7) inhibitor given orally once daily until disease progression
OG006
Module 4 120 mg OD Fasted
Participants with advanced solid tumours will receive CT7001(samuraciclib) oral monotherapy in a randomized, balanced, single-dose, two-treatment (fed v fasting), two-period, two-sequence crossover study followed by once daily continuous dosing.
CT7001: Cyclin-dependent kinase 7 (CDK7) inhibitor given orally once daily until disease progression
OG007
Module 4 360 mg OD Fed
Participants with advanced solid tumours will receive CT7001(samuraciclib) oral monotherapy in a randomized, balanced, single-dose, two-treatment (fed v fasting), two-period, two-sequence crossover study followed by once daily continuous dosing.
CT7001: Cyclin-dependent kinase 7 (CDK7) inhibitor given orally once daily until disease progression
OG008
Module 4 360 mg OD Fasted
Participants with advanced solid tumours will receive CT7001(samuraciclib) oral monotherapy in a randomized, balanced, single-dose, two-treatment (fed v fasting), two-period, two-sequence crossover study followed by once daily continuous dosing.
CT7001: Cyclin-dependent kinase 7 (CDK7) inhibitor given orally once daily until disease progression
Units
Counts
Participants
OG0005
OG0019
OG0021
OG0038
OG0043
OG0053
OG0067
OG0075
OG0087
Title
Denominators
Categories
Title
Measurements
OG000802.9± 83.83
OG0011926± 18.75
OG0022506± NA"NA" indicates that data could not be evaluated due to smaller number of participants
OG0032791± 27.63
OG0041377± 15.21
OG005785.3± 14.26
OG006694.9± 55.93
OG0072696± 41.38
OG0082545± 66.10
OG001
Module 1 Part A-Cohort 2 240 mg OD
Dose Escalation Phase-Participants received a single dose of CT7001 on Day 1 of Cycle 0 (C0D1) followed by a 2-day washout period (C0D2), before receiving cycles of 21 continuous days dosing of CT7001 capsules. Dosing was continued until the participant was no longer gaining clinical benefit or another treatment discontinuation criterion was met, at which time an end of treatment visit was conducted. Once the MBAD was determined and agreed by the SRC, the paired biopsy expansion cohort in patients with breast cancer commenced at the selected dose
OG002
Module 1 Part A-Cohort 3 480 mg OD
Dose Escalation Phase-Participants received a single dose of CT7001 on Day 1 of Cycle 0 (C0D1) followed by a 2-day washout period (C0D2), before receiving cycles of 21 continuous days dosing of CT7001 capsules. Dosing was continued until the participant was no longer gaining clinical benefit or another treatment discontinuation criterion was met, at which time an end of treatment visit was conducted.
OG003
Module 1 Part A-Cohort 4 360 mg OD
Dose Escalation Phase-Participants received a single dose of CT7001 on Day 1 of Cycle 0 (C0D1) followed by a 2-day washout period (C0D2), before receiving cycles of 21 continuous days dosing of CT7001 capsules. Dosing was continued until the participant was no longer gaining clinical benefit or another treatment discontinuation criterion was met, at which time an end of treatment visit was conducted.
Once the MBAD was determined and agreed by the SRC, the paired biopsy expansion cohort in patients with breast cancer commenced at the selected dose.
OG004
Module 1 Part A-Cohort 5 180 mg BID
Dose Escalation Phase-Participants received twice daily dose of CT7001 on Day 1 of Cycle 0 (C0D1) followed by a 2-day washout period (C0D2), before receiving cycles of 21 continuous days dosing of CT7001 capsules. Dosing was continued until the participant was no longer gaining clinical benefit or another treatment discontinuation criterion was met, at which time an end of treatment visit was conducted.
OG005
Module 1 Part B-1 Triple-negative Breast Cancer (TNBC) Expansion
Dose Escalation Phase-Participants with locally advanced or metastatic triple-negative breast cancer (TNBC) will receive CT7001(samuraciclib) as oral monotherapy at the dose, frequency and schedule recommended from Module 1 Part A.
CT7001: Cyclin-dependent kinase 7 (CDK7) inhibitor given orally once daily until disease progression
OG006
Module 1 Part B-2 Castrate Resistant Prostate Cancer (CRPC) Expansion
Participants with castrate resistant prostate cancer will receive CT7001(samuraciclib) as oral monotherapy at the dose, frequency and schedule recommended from Module 1 Part A.
CT7001: Cyclin-dependent kinase 7 (CDK7) inhibitor given orally once daily until disease progression
OG007
Module 2 Part A CT7001 240 mg OD + Fulvestrant (Cohort 1)
Participants with locally advanced or metastatic HR+ve and HER2-ve breast cancer will receive CT7001 (samuraciclib) at the dose, frequency and schedule recommended from Module 1 part A and will receive Fulvestrant solution in pre-filled syringe for intramuscular (IM) injection
CT7001: Cyclin-dependent kinase 7 (CDK7) inhibitor given orally once daily until disease progression
Fulvestrant: Administered as 2 x 250mg intramuscular (IM) gluteal injections on Day 1, Day 15, Day 28 and every 28 days thereafter.
OG008
Module 2 Part A CT7001 360 mg OD + Fulvestrant (Cohort 2)
Participants with locally advanced or metastatic HR+ve and HER2-ve breast cancer will receive CT7001 (samuraciclib) at the dose, frequency and schedule recommended from Module 1 part A and will receive Fulvestrant solution in pre-filled syringe for intramuscular (IM) injection.
CT7001: Cyclin-dependent kinase 7 (CDK7) inhibitor given orally once daily until disease progression.
Fulvestrant: Administered as 2 x 250mg intramuscular (IM) gluteal injections on Day 1, Day 15, Day 28 and every 28 days thereafter.
OG009
Module 4 240 mg OD (Continuous Dosing Phase)
Module 4 evaluated the effect of food on the PK of CT7001 using a randomized, balanced, single-dose, two-treatment (fed vs. fasting), two-period, two-sequence crossover design, followed by a continuous treatment phase.
OG010
Module 4 360 mg OD (Continuous Dosing Phase)
Module 4 evaluated the effect of food on the PK of CT7001 using a randomized, balanced, single-dose, two-treatment (fed vs. fasting), two-period, two-sequence crossover design, followed by a continuous treatment phase.
Units
Counts
Participants
OG0005
OG0019
OG0021
OG00312
OG0048
OG00523
OG00611
OG0076
OG00825
OG0098
OG0107
Title
Denominators
Categories
Title
Measurements
OG00016.12± 71.17
OG00144.60± 32.05
OG00260.60± NANA indicates that data could not be evaluated due to smaller number of participants
OG00363.40± 47.89
OG00455.91± 78.90
OG00539.22± 41.48
OG00641.56± 47.94
OG007NA± NANA indicates that data could not be evaluated due to insufficient blood volume.
OG00868.97± 69.2
OG00947.87± 41.44
OG01034.26± 138.3
Participants with locally advanced or metastatic HR+ve and HER2-ve breast cancer will receive CT7001 (samuraciclib) at the dose, frequency and schedule recommended from Module 1 part A and will receive Fulvestrant solution in pre-filled syringe for intramuscular (IM) injection.
CT7001: Cyclin-dependent kinase 7 (CDK7) inhibitor given orally once daily until disease progression.
Fulvestrant: Administered as 2 x 250mg intramuscular (IM) gluteal injections on Day 1, Day 15, Day 28 and every 28 days thereafter.
Units
Counts
Participants
OG0006
OG00125
Title
Denominators
Categories
Title
Measurements
OG00012.65± 13.88
OG00112.47± 36.96
OG001
Module 1 Part A-Cohort 2 240mg OD
Dose Escalation Phase- Participants received a single dose of CT7001 on Day 1 of Cycle 0 (C0D1) followed by a 2-day washout period (C0D2), before receiving cycles of 21continuous days dosing of CT7001capsules. Dosing was continued until the participant was no longer gaining clinical benefit or another treatment discontinuation criterion was met, at which time an end of treatment visit was conducted. Once the MBAD was determined and agreed by the SRC, the paired biopsy expansion cohort in patients with breast cancer commenced at the selected dose.
OG002
Module 1 Part A-Cohort 3 480 mg OD
Dose Escalation Phase-Participants received a single dose of CT7001 on Day1 of Cycle 0 (C0D1) followed by a 2-day washout period(C0D2), before receiving cycles of 21 continuous days dosing of CT7001 capsules. Dosing was continued until the participant was no longer gaining clinical benefit or another treatment discontinuation criterion was met, at which time an end of treatment visit was conducted.
OG003
Module 1 Part A-Cohort 4 360mg OD
Dose Escalation Phase-Participants received a single dose of CT7001 on Day1 of Cycle 0 (C0D1) followed by a 2-day washout period(C0D2), before receiving cycles of 21 continuous days dosing of CT7001capsules.Dosing was continued until the participant was no longer gaining clinical benefit or another treatment discontinuation criterion was met, at which time an end of treatment visit was conducted.
Once the MBAD was determined and agreed by the SRC, the paired biopsy expansion cohort inpatients with breast cancer commenced at the selected dose.
OG004
Module 1 Part A-Cohort 5 180mg BID
Dose Escalation Phase-Participants received twice daily dose of CT7001 on Day1 of Cycle 0(C0D1) followed by a 2-day washout period(C0D2), before receiving cycles of 21continuous days dosing of CT7001capsules.Dosing was continued until the participant was no longer gaining clinical benefit or another treatment discontinuation criterion was met, at which time an end of treatment visit was conducted.
OG005
Module 1 Part A Paired Biopsy Breast Cancer Expansion Cohort-240mg
Participants with locally advanced or metastatic breast cancer will receiveCT7001(samuraciclib)as oral monotherapy at the minimally biologically active dose(MBAD) and recommended dose for Phase II testing(RP2D).
OG006
Module 1 Part A Paired Biopsy Breast Cancer Expansion Cohort-360mg
Participants with locally advanced or metastatic breast cancer will receive CT7001(samuraciclib)as oral monotherapy at the minimally biologically active dose(MBAD) and recommended dose for Phase II testing(RP2D).
OG007
Module 1 Part B-1 Triple-negative Breast Cancer (TNBC) Expansion
Participants with locally advanced or metastatic triple-negative breast cancer (TNBC) will receive CT7001(samuraciclib) as oral monotherapy at the dose, frequency and schedule recommended from Module 1 Part A.
CT7001: Cyclin-dependent kinase 7 (CDK7) inhibitor given orally once daily until disease progression
OG008
Module 1 Part B-2 Castrate Resistant Prostate Cancer (CRPC) Expansion
Participants with castrate resistant prostate cancer will receive CT7001(samuraciclib) as oral monotherapy at the dose, frequency and schedule recommended from Module 1 Part A.
CT7001: Cyclin-dependent kinase 7 (CDK7) inhibitor given orally once daily until disease progression
OG009
Module 2 Part ACT7001 240 mg OD +Fulvestrant (Cohort 1)
Participants with locally advanced or metastatic HR+ve andHER2-ve breast cancer will receiveCT7001(samuraciclib) at the dose, frequency and schedule recommended from Module 1 part A and will receive Fulvestrant solution in pre-filled syringe for intramuscular (IM)injection CT7001: Cyclin-dependent kinase 7(CDK7) inhibitor given orally once daily until disease progression Fulvestrant: Administered as 2 x250mg intramuscular(IM) gluteal injections on Day 1, Day 15,Day 28 and every 28days thereafter.
OG010
Module 2 Part ACT7001 360 mg OD + Fulvestrant (Cohort 2)
Participants with locally advanced or metastatic HR+ve and HER2-ve breast cancer will receive CT7001 (samuraciclib) at the dose, frequency and schedule recommended from Module 1 part A and will receive Fulvestrant solution in pre-filled syringe for intramuscular (IM) injection
CT7001: Cyclin-dependent kinase 7 (CDK7) inhibitor given orally once daily until disease progression
Fulvestrant: Administered as 2 x 250mg intramuscular (IM) gluteal injections on Day 1, Day 15, Day 28 and every 28 days thereafter.
OG011
Module 4-120mg OD Fed
Module 4 evaluated the effect of food on the PK of CT7001using a randomized, balanced, single-dose, two treatment (fed vs. fasting), two-period, two-sequence crossover design, followed by a continuous treatment phase. 120mg fed data combined and presented for Sequence 1, Period 1 and Sequence 2, Period 2.
OG012
Module 4 120mg OD Fasted
Module 4 evaluated the effect of food on the PK of CT7001 using a randomized, balanced, single-dose, two treatment (fed vs. fasting), two-period, two-sequence crossover design, followed by a continuous treatment phase. 120 mg fasted data combined and presented for Sequence 1, Period 2 and Sequence 2, Period 1
OG013
Module 4 360mg OD Fed
Module 4 evaluated the effect of food on the PK of CT7001 using a randomized, balanced, single-dose, two treatment (fed vs. fasting), two-period, two-sequence crossover design, followed by a continuous treatment phase. 360mg fed data combined and presented for Sequence 3, Period 1 and Sequence 4, Period 2.
OG014
Module 4 360mg OD Fasted
Module 4 evaluated the effect of food on the PK of CT7001 using a randomized, balanced, single-dose, two treatment (fed vs. fasting), two-period, two-sequence crossover design, followed by a continuous treatment phase. 360mg fasted data combined and presented for Sequence 3, Period 2 and Sequence 4, Period 1.
OG015
Module 4 240 mg OD Continuous Dosing
Module 4 evaluated the effect of food on the PK of CT7001using a randomized, balanced, single-dose, two-treatment (fed vs. fasting), two-period, two-sequence cross over design, followed by a continuous treatment phase.
OG016
Module 4 360 mg OD Continuous Dosing
Module 4 evaluated the effect of food on the PK of CT7001using a randomized, balanced, single-dose, two-treatment (fed vs. fasting), two-period, two-sequence cross over design, followed by a continuous treatment phase.
Units
Counts
Participants
OG0006
OG0015
OG0022
OG0036
OG0047
OG0055
OG0065
OG00723
OG00811
OG0096
OG01019
OG0110
OG0120
OG0130
OG0140
OG0158
OG0167
Title
Denominators
Categories
Complete response
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
OG0080
OG0090
OG0100
OG0150
OG0160
Partial response
Title
Measurements
OG0000
OG0010
OG0020
OG003
Stable disease
Title
Measurements
OG0002
OG0013
OG0020
OG003
Progressive disease
Title
Measurements
OG0004
OG0012
OG0022
OG003
Not evaluable
Title
Measurements
OG0000
OG0010
OG0020
OG003
OG001
Module 1 Part A-Cohort 2 240 mg OD
Dose Escalation Phase-Participants received a single dose of CT7001 on Day 1 of Cycle 0 (C0D1) followed by a 2-day washout period (C0D2), before receiving cycles of 21 continuous days dosing of CT7001 capsules.
Dosing was continued until the participant was no longer gaining clinical benefit or another treatment discontinuation criterion was met, at which time an end of treatment visit was conducted. Once the MBAD was determined and agreed by the SRC, the paired biopsy expansion cohort in patients with breast cancer commenced at the selected dose.
OG002
Module 1 Part A-Cohort 3 480 mg OD
Dose Escalation Phase-Participants received a single dose of CT7001 on Day 1 of Cycle 0 (C0D1) followed by a 2-day washout period (C0D2), before receiving cycles of 21 continuous days dosing of CT7001 capsules.
Dosing was continued until the participant was no longer gaining clinical benefit or another treatment discontinuation criterion was met, at which time an end of treatment visit was conducted.
OG003
Module 1 Part A-Cohort 4 360 mg OD
Dose Escalation Phase-Participants received a single dose of CT7001 on Day 1 of Cycle 0 (C0D1) followed by a 2-day washout period (C0D2), before receiving cycles of 21 continuous days dosing of CT7001 capsules.
Dosing was continued until the participant was no longer gaining clinical benefit or another treatment discontinuation criterion was met, at which time an end of treatment visit was conducted.
Once the MBAD was determined and agreed by the SRC, the paired biopsy expansion cohort in patients with breast cancer commenced at the selected dose.
OG004
Module 1 Part A-Cohort 5 180 mg BID
Dose Escalation Phase-Participants received twice daily dose of CT7001 on Day 1 of Cycle 0 (C0D1) followed by a 2-day washout period (C0D2), before receiving cycles of 21 continuous days dosing of CT7001 capsules. Dosing was continued until the participant was no longer gaining clinical benefit or another treatment discontinuation criterion was met, at which time an end of treatment visit was conducted.
OG005
Module 1 Part A Paired Biopsy Breast Cancer Expansion Cohort-240mg
Participants with locally advanced or metastatic breast cancer will receive CT7001 (samuraciclib) as oral monotherapy at the minimally biologically active dose (MBAD) and recommended dose for Phase II testing (RP2D).
OG006
Module 1 Part A Paired Biopsy Breast Cancer Expansion Cohort-360mg
Participants with locally advanced or metastatic breast cancer will receive CT7001 (samuraciclib) as oral monotherapy at the minimally biologically active dose (MBAD) and recommended dose for Phase II testing (RP2D).
OG007
Module 1 Part B-1 Triple-negative Breast Cancer (TNBC) Expansion
Participants with locally advanced or metastatic triple-negative breast cancer (TNBC) will receive CT7001(samuraciclib) as oral monotherapy at the dose, frequency and schedule recommended from Module 1 Part A.
OG008
Module 1 Part B-2 Castrate Resistant Prostate Cancer (CRPC) Expansion.
Participants with castrate resistant prostate cancer will receive CT7001(samuraciclib) as oral monotherapy at the dose, frequency and schedule recommended from Module 1 Part A.
CT7001: Cyclin-dependent kinase 7 (CDK7) inhibitor given orally once daily until disease progression.
OG009
Module 2 Part ACT7001 240 mg OD + Fulvestrant (Cohort 1)
Participants with locally advanced or metastatic HR+ve andHER2-ve breast cancer will receiveCT7001(samuraciclib) at the dose, frequency and schedule recommended from Module 1 part A and will receive Fulvestrant solution in pre-filled syringe for intramuscular (IM)injection CT7001: Cyclin-dependent kinase 7(CDK7) inhibitor given orally once daily until disease progression Fulvestrant: Administered as 2 x250mg intramuscular(IM) gluteal injections on Day 1, Day 15,Day 28 and ever
OG010
Module 2 Part ACT7001 360 mg OD + Fulvestrant (Cohort 2)
Participants with locally advanced or metastatic HR+ve andHER2-ve breast cancer will receiveCT7001(samuraciclib) at the dose, frequency and schedule recommended from Module 1 part A and will receive Fulvestrant solution in pre-filled syringe for intramuscular (IM)injection CT7001: Cyclin-dependent kinase 7(CDK7) inhibitor given orally once daily until disease progression Fulvestrant: Administered as 2 x250mg intramuscular(IM) gluteal injections on Day 1, Day 15,Day 28 and ever
OG011
Module 4 120 mg OD Fed
Module 4 evaluated the effect of food on the PK of CT7001 using a randomized, balanced, single-dose, two treatment (fed vs. fasting), two-period, two-sequence crossover design, followed by a continuous treatment phase. Sequence 1:120 mg CT7001 fed in Period 1 followed by 120mg CT7001 fasted in Period 2. This was followed by 240mg OD continuous dosing.
OG012
Module 4 120mg OD Fasted
Module 4 evaluated the effect of food on the PK of CT7001 using a randomized, balanced, single-dose, twotreatment (fed vs. fasting), two-period, two-sequence cross overdesign, followed by a continuous treatment phase. Sequence 2:120 mg CT7001 fasted in Period1 followed by 120 mg CT7001 fed in Period 2. This was followed by 240mg OD continuous dosing.
OG013
Module 4 360 mg OD Fed
Module 4 evaluated the effect of food on the PK of CT7001 using a randomized, balanced, single-dose, twotreatment (fed vs. fasting), two-period, two-sequence crossover design, followed by a continuous treatment phase. Sequence 3: 360 mg CT7001 fed in Period 1 followed by 360mg CT7001 fasted in Period 2. This was followed by 360mg OD continuous dosing.
OG014
Module 4 360mg OD Fasted
Module 4 evaluated the effect of food on the PK of CT7001 using a randomized, balanced, single-dose, two treatment (fed vs. fasting),two-period, two-sequence crossover design, followed by a continuous treatment phase. Sequence 4: 360 mg CT7001 fasted in Period1 followed by 360 mg CT7001 fed in Period 2. This was followed by 360 mg OD continuous dosing.
OG015
Module 4 240 mg OD Continuous Dosing
Module 4 evaluated the effect of food on the PK of CT7001 using a randomized, balanced, single-dose, two treatment (fed vs. fasting), two-period, two-sequence crossover design, followed by a continuous treatment phase. 240mg OD continuous dosing (sequence 1 and 2 participants combined).
OG016
Module 4 360 mg OD Continuous Dosing
Module 4 evaluated the effect of food on the PK of CT7001 using a randomized, balanced, single-dose, two treatment (fed vs. fasting), two-period, two-sequence crossover design, followed by a continuous treatment phase.
360mg OD continuous dosing (sequence 3 and 4 participants combined.
Units
Counts
Participants
OG0006
OG0015
OG0022
OG0036
OG0047
OG0055
OG0065
OG0076
OG00811
OG0096
OG01025
OG0116
OG0128
OG0137
OG0147
OG0158
OG0167
Title
Denominators
Categories
Title
Measurements
OG000NA(NA to NA)"NA" indicates that the value could not be evaluated due to an insufficient number of participants/events.
OG001NA(NA to NA)"NA" indicates that the value could not be evaluated due to an insufficient number of participants/events.
OG002NA(NA to NA)"NA" indicates that the value could not be evaluated due to an insufficient number of participants/events.
OG003NA(NA to NA)"NA" indicates that the value could not be evaluated due to an insufficient number of participants/events.
OG004NA(NA to NA)"NA" indicates that the value could not be evaluated due to an insufficient number of participants/events.
OG005NA(NA to NA)"NA" indicates that the value could not be evaluated due to an insufficient number of participants/events.
OG006NA(NA to NA)"NA" indicates that the value could not be evaluated due to an insufficient number of participants/events.
OG00772(56 to 113)
OG008NA(NA to NA)"NA" indicates that the value could not be evaluated due to an insufficient number of participants/events.
OG009107(51 to NA)"NA" indicates that the value could not be evaluated due to an insufficient number of participants/events.
OG010114(56 to 421)
OG011NA(NA to NA)"NA" indicates that the value could not be evaluated due to an insufficient number of participants/events.
OG012NA(NA to NA)"NA" indicates that the value could not be evaluated due to an insufficient number of participants/events.
OG013NA(NA to NA)"NA" indicates that the value could not be evaluated due to an insufficient number of participants/events.
OG014NA(NA to NA)"NA" indicates that the value could not be evaluated due to an insufficient number of participants/events.
OG015NA(NA to NA)"NA" indicates that the value could not be evaluated due to an insufficient number of participants/events.
OG016NA(NA to NA)"NA" indicates that the value could not be evaluated due to an insufficient number of participants/events.
Module 1 Part A-Cohort 2 240mg OD
Dose Escalation Phase- Participants received a single dose of CT7001 on Day 1 of Cycle 0 (D0D1) followed by a 2-day washout period (C0D2), before receiving cycles of 21 continuous days dosing of CT7001 capsules.
Dosing was continued until the participant was not longer gaining clinical benefit or another treatment discontinuation criterion was met, at which time an end of treatment visit was conducted. Once the MBAD was determined and agreed by the SRC, the paired biopsy expansion cohort in patients with breast cancer commenced at the selected dose.
OG002
Module 1 Part A-Cohort 3 480mg OD
Dose Escalation Phase- Participants received a single dose of CT7001 on Day 1 of Cycle 0 (D0D1) followed by a 2-day washout period (C0D2), before receiving cycles of 21 continuous days dosing of CT7001 capsules.
Dosing was continued until the participant was not longer gaining clinical benefit or another treatment discontinuation criterion was met, at which time an end of treatment visit was conducted.
OG003
Module 1 Part A-Cohort 4 360mg OD
Dose Escalation Phase- Participants received a single dose of CT7001 on Day 1 of Cycle 0 (D0D1) followed by a 2-day washout period (C0D2), before receiving cycles of 21 continuous days dosing of CT7001 capsules.
Dosing was continued until the participant was not longer gaining clinical benefit or another treatment discontinuation criterion was met, at which time an end of treatment visit was conducted. Once the MBAD was determined and agreed by the SRC, the paired biopsy expansion cohort in patients with breast cancer commenced at the selected dose.
OG004
Module 1 Part A-Cohort 5 180mg BID
Dose Escalation Phase- Participants received a single dose of CT7001 on Day 1 of Cycle 0 (D0D1) followed by a 2-day washout period (C0D2), before receiving cycles of 21 continuous days dosing of CT7001 capsules.
Dosing was continued until the participant was not longer gaining clinical benefit or another treatment discontinuation criterion was met, at which time an end of treatment visit was conducted.
OG005
Module 1 Part A Paired Biopsy Breast Cancer Expansion Cohort-240mg
Participants with locally advanced or metastatic breast cancer will receive CT7001 (samuraciclib) as oral monotherapy at the minimally biologically active dose (MBAD) and recommended dose for Phase II testing (RP2D).
OG006
Module 1 Part A Paired Biopsy Breast Cancer Expansion Cohort-360mg
Participants with locally advanced or metastatic breast cancer will receive CT7001 (samuraciclib) as oral monotherapy at the minimally biologically active dose (MBAD) and recommended dose for Phase II testing (RP2D).
OG007
Module 1 Part B-1 Triple-negative Breast Cancer (TNBC) Expansion
Dose Escalation Phase-Participants with locally advanced or metastatic triple-negative breast cancer (TNBC) will receive CT7001(samuraciclib) as oral monotherapy at the dose, frequency and schedule recommended from Module 1 Part A. CT7001: Cyclin-dependent kinase 7 (CDK7) inhibitor given orally once daily until disease progression.
OG008
Module 1 Part B-2 Castrate Resistant Prostate Cancer (CRPC) Expansion
Participants with castrate resistant prostate cancer will receive CT7001(samuraciclib) as oral monotherapy at the dose, frequency and schedule recommended from Module 1 Part A. CT7001: Cyclin-dependent kinase 7 (CDK7) inhibitor given orally once daily until disease progression.
OG009
Module 2 Part ACT7001 240 mg OD + Fulvestrant (Cohort 1)
Participants with locally advanced or metastatic HR+ve andHER2-ve breast cancer will receiveCT7001(samuraciclib) at the dose, frequency and schedule recommended from Module 1 part A and will receive Fulvestrant solution in pre-filled syringe for intramuscular (IM)injection CT7001: Cyclin-dependent kinase 7(CDK7) inhibitor given orally once daily until disease progression Fulvestrant: Administered as 2 x250mg intramuscular(IM) gluteal injections on Day 1, Day 15,Day 28 and ever
OG010
Module 2 Part ACT7001 360 mg OD + Fulvestrant (Cohort 2)
Participants with locally advanced or metastatic HR+ve andHER2-ve breast cancer will receiveCT7001(samuraciclib) at the dose, frequency and schedule recommended from Module 1 part A and will receive Fulvestrant solution in pre-filled syringe for intramuscular (IM)injection CT7001: Cyclin-dependent kinase 7(CDK7) inhibitor given orally once daily until disease progression Fulvestrant: Administered as 2 x250mg intramuscular(IM) gluteal injections on Day 1, Day 15,Day 28 and ever
OG011
Module 4 120mg OD Fed
Module 4 evaluated the effect of food on the PK of CT7001using a randomized, balanced, single-dose, two treatment (fed vs. fasting), two-period, two-sequence crossover design, followed by a continuous treatment phase. 120mg fed data combined and presented for Sequence 1, Period 1 and Sequence 2, Period 2.
OG012
Module 4 120mg OD Fasted
Module 4 evaluated the effect of food on the PK of CT7001using a randomized, balanced, single-dose, two treatment (fed vs. fasting), two-period, two-sequence crossover design, followed by a continuous treatment phase. 120mg fasted data combined and presented for Sequence 1, Period 2 and Sequence 2, Period 1.
OG013
Module 4 360mg OD Fed
Module 4 evaluated the effect of food on the PK of CT7001using a randomized, balanced, single-dose, two treatment (fed vs. fasting), two-period, two-sequence crossover design, followed by a continuous treatment phase. 360mg fed data combined and presented for Sequence 3, Period 1 and Sequence 4, Period 2.
OG014
Module 4 360mg OD Fasted
Module 4 evaluated the effect of food on the PK of CT7001using a randomized, balanced, single-dose, two treatment (fed vs. fasting), two-period, two-sequence crossover design, followed by a continuous treatment phase. 360mg fasted data combined and presented for Sequence 3, Period 2 and Sequence 4, Period 1.
OG015
Module 4 240mg OD Continuous Dosing
Module 4 evaluated the effect of food on the PK of CT7001using a randomized, balanced, single-dose, twotreatment (fed vs. fasting), two-period, two-sequence crossover design, followed by a continuous treatment phase. 240mg OD continuous dosing data combined and presented for Sequence 1 and Sequence 2 participants.
OG016
Module 4 360mg OD Continous Dosing
Module 4 evaluated the effect of food on the PK of CT7001using a randomized, balanced, single-dose, twotreatment (fed vs. fasting), two-period, two-sequence crossover design, followed by a continuous treatment phase. 360mg OD continuous dosing data combined and presented for Sequence 3 and Sequence 4 participants.
Units
Counts
Participants
OG0006
OG0015
OG0022
OG0036
OG0047
OG0055
OG0065
OG00723
OG00811
OG0096
OG01019
OG0116
OG0128
OG0137
OG0147
OG0158
OG0167
Title
Denominators
Categories
Title
Measurements
OG000NA"NA" indicates that due to the limited number of participants and/or events in certain cohorts, CBR values could not be calculated.
OG001NA"NA" indicates that due to the limited number of participants and/or events in certain cohorts, CBR values could not be calculated.
OG002NA"NA" indicates that due to the limited number of participants and/or events in certain cohorts, CBR values could not be calculated.
OG003NA"NA" indicates that due to the limited number of participants and/or events in certain cohorts, CBR values could not be calculated.
OG004NA"NA" indicates that due to the limited number of participants and/or events in certain cohorts, CBR values could not be calculated.
OG005NA"NA" indicates that due to the limited number of participants and/or events in certain cohorts, CBR values could not be calculated.
OG006NA"NA" indicates that due to the limited number of participants and/or events in certain cohorts, CBR values could not be calculated.
OG007NA"NA" indicates that due to the limited number of participants and/or events in certain cohorts, CBR values could not be calculated.
OG008NA"NA" indicates that due to the limited number of participants and/or events in certain cohorts, CBR values could not be calculated.
OG00916.7
OG01042.1
OG011NA"NA" indicates that due to the limited number of participants and/or events in certain cohorts, CBR values could not be calculated.
OG012NA"NA" indicates that due to the limited number of participants and/or events in certain cohorts, CBR values could not be calculated.
OG013NA"NA" indicates that due to the limited number of participants and/or events in certain cohorts, CBR values could not be calculated.
OG014NA"NA" indicates that due to the limited number of participants and/or events in certain cohorts, CBR values could not be calculated.
OG015NA"NA" indicates that due to the limited number of participants and/or events in certain cohorts, CBR values could not be calculated.
OG016NA"NA" indicates that due to the limited number of participants and/or events in certain cohorts, CBR values could not be calculated.