First Time in Humans (FTIH) Study of GSK3368715 in Partic... | NCT03666988 | Trialant
NCT03666988
Sponsor
GlaxoSmithKline
Status
Terminated
Last Update Posted
May 20, 2022Actual
Enrollment
31Actual
Phase
Phase 1
Conditions
Neoplasms
Interventions
GSK3368715
GSK3368715
Countries
United States
Australia
Canada
Spain
Protocol Section
Identification Module
NCT ID
NCT03666988
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
207675
Secondary IDs
ID
Type
Description
Link
2018-001629-20
EudraCT Number
Brief Title
First Time in Humans (FTIH) Study of GSK3368715 in Participants With Solid Tumors and Diffuse Large B-cell Lymphoma (DLBCL)
Official Title
A Phase I, Open-label, Dose-escalation Study to Investigate the Safety, Pharmacokinetics, Pharmacodynamics and Clinical Activity of GSK3368715 in Participants With Solid Tumors and DLBCL
Acronym
Not provided
Organization
GlaxoSmithKlineINDUSTRY
Status Module
Record Verification Date
Feb 2022
Overall Recruitment Status or Expanded Access Status
Terminated
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Overall benefit-risk profile did not support continuation of the study
Expanded Access Info
No
Start Date
Oct 22, 2018Actual
Primary Completion Date
Mar 4, 2021Actual
Completion Date
Mar 4, 2021Actual
First Submitted Date
Sep 10, 2018
First Submission Date that Met QC Criteria
Sep 10, 2018
First Posted Date
Sep 12, 2018Actual
Results Waived
Not provided
Results First Submitted Date
Mar 1, 2022
Results First Submitted that Met QC Criteria
Mar 1, 2022
Results First Posted Date
May 20, 2022Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Mar 1, 2022
Last Update Posted Date
May 20, 2022Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
GlaxoSmithKlineINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
No
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
Arginine methylation mediated by protein arginine methyl-transferases (PRMTs) is an important post-translational modification of proteins involved in a diverse range of cellular processes. Misregulation and overexpression of PRMT1 (a type I PRMT) has been associated with a number of solid and hematopoietic cancers. GSK3368715 leads to inhibition of tumor cell growth across tumor types with cytotoxic response observed in lymphoma, acute myeloid leukemia (AML) and a subset of solid tumor cell lines. This study will assess the safety, pharmacokinetics (PK), pharmacodynamics (PD), food effect and preliminary clinical activity of GSK33368715 in participants with relapsed/refractory DLBCL and selected solid tumors with frequent methyl-thioadenosine phosphorylase (MTAP)-deficiency. The study will consist of two parts. In Part 1 (Dose Escalation) escalating doses of GSK3368715 will be evaluated and recommended phase 2 dose (RP2D) will be established in participants with selected solid relapsed/refractory tumors. Once a RP2D is identified, a food effect sub-study will be initiated to determine the effect of a high-fat, high calorie meal on the bioavailability of GSK3368715. In Part 2 (Dose Expansion), this RP2D will be further investigated in two expansion cohorts; participants with DLBCL (Expansion Cohort 2A) and relapsed/refractory solid tumors including pancreatic, bladder, and non-small cell lung cancer (NSCLC)(Expansion Cohort 2B). The study includes a screening period, an intervention period and follow up.
Detailed Description
Not provided
Conditions Module
Conditions
Neoplasms
Keywords
Dose-escalation
First time in humans
Solid tumors
GSK3368715
Diffuse Large B-Cell Lymphoma
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 1
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
31Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Part 1: GSK3368715 dose escalation
Experimental
Eligible participants with solid relapsed/refractory tumors will receive escalating doses of GSK3368715 at a starting dose of 50 mg, administered orally once daily.
Drug: GSK3368715
Part 1: GSK3368715 PK/PD/Metabolite/Biomarker
Experimental
Additional participants in Part 1, treated at or close to the expected the maximum tolerated dose (MTD)/RP2D, will be evaluated for metabolic and biomarker profiling. Participants may be enrolled into this cohort(s) even after MTD/RP2D has been identified and Part 2 has been initiated.
Drug: GSK3368715
Part 1: GSK3368715 Food effect
Experimental
Eligible participants will receive single dose of GSK3368715 at starting dose of 50 mg tablet orally in fasted state followed by fed state in Period 1 and Fed followed by fasted state in Period 2.
Drug: GSK3368715
Part 2:GSK3368715 dose expansion - DLBCL participants
Experimental
Eligible participants with relapsed/refractory DLBCL will receive RP2D of GSK3368715 established during Part 1, administered orally once daily.
Drug: GSK3368715
Part 2:GSK3368715 dose expansion-solid tumor participants
Experimental
Interventions
Name
Type
Description
Arm Group Labels
Other Names
GSK3368715
Drug
GSK3368715 will be available with dosing strengths of 25 mg, 100 mg and 250 mg to be administered once daily as an oral capsule.
Part 1: GSK3368715 PK/PD/Metabolite/Biomarker
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Part 1: Number of Participants With Dose Limiting Toxicities (DLTs)
A DLT is considered by the investigator to be clinically relevant,attributed event during the first 21days of intervention meeting the following criteria:Non-hematologic toxicity:Aspartate Aminotransferase(AST)/Alanine Aminotransferase(ALT) Grade 3/4,ALT>=5 times Upper limit of Normal(ULN),ALT>=3times ULN(>=4 weeks),ALT>=3 times ULN plus(+)bilirubin>=2 times ULN,ALT >= 3 times ULN+liver symptoms or International Normalization Ratio(INR)>1.5.Nausea:Grade 3;Vomiting or diarrhea:Grade3/4(>3days);Fatigue:Grade 3(>5days).Hypertension:Uncontrolled Grade 3/4.Electrocardiogram(ECG)-change:>20 milliseconds(msec) QRS extension.Lab abnormality:uncontrolled Grade3(>3days)/Grade4.Hematologic toxicity:Neutropenia:uncontrolled Grade3(>3days)/febrile neutropenia/Grade 4.Thrombocytopenia:uncontrolled Grade 3(>3days)/Grade 3(clinically significant Hemorrhage)/Grade 4.Venous thromboembolism (VTE):Grade2 needing systemic anticoagulation/Grade>=3 during the first 8 weeks or if sooner,study discontinuation
Up to 21 days
Part 1: Number of Participants With Non-Serious Adverse Events (Non-SAEs) and SAEs
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. Any untoward event resulting in death, life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, congenital anomaly/birth defect or any other situation according to medical or scientific judgment is categorized as SAE.
Up to 28 months
Part 1: Number of Participants With AEs by Severity Grades
All adverse events were analyzed using National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5.0. Graded from Grade 1: mild asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated, Grade 2: Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental activities of daily living (ADL), Grade 3: Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care ADL, Grade 4: Life-threatening consequences; urgent intervention indicated, Grade 5: death related AE. Higher grade indicates more severe condition. Number of participants with maximum severity grades are presented.
Secondary Outcomes
Measure
Description
Time Frame
Part 1: Percentage of Participants Achieving Best Overall Response Rate
Overall response rate is defined as the percentage of participants with a confirmed complete response (CR) or a partial response (PR). Participants with solid tumor were assessed per Response Criteria for Solid Tumors (RECIST) 1.1 and DLBCL participants were assessed per Lugano Criteria. The best ORR was recorded from the start of the intervention until disease progression/recurrence and was determined based on the investigator's assessment of response at each time point. The percentage of participants achieving best overall response rate have been presented.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Participant must be >=18 to years of age inclusive, at the time of signing the informed consent.
Diagnosis of one of the following; Part 1 (Dose Escalation and food effect): Histologically- or cytological-confirmed diagnosis of solid tumor malignancy that is metastatic or non-resectable; have received all standard treatment options or are no longer eligible for additional standard treatment options. Evaluable disease that may be measured directly by the size of the tumor or can be evaluated by other methods. Availability of a biopsy of the tumor tissue obtained at any time from the initial diagnosis to study entry. Although a fresh biopsy, which is obtained during screening, is preferred, archival tumor specimen is acceptable if it is not feasible to obtain a fresh biopsy. For participants in the PK/PD cohort, a fresh biopsy and consent for one on treatment biopsy are required for enrollment. Part 2 (Dose Expansion): Cohort 2A & 2B: The availability of archival tumor tissue, or willingness to undergo a fresh biopsy to determine MTAP status (any archival tumor specimen must have been obtained within 6 months prior to starting study drug unless approved by the study Medical Monitor). Local MTAP or Cyclin Dependent Kinase Inhibitor 2A (CDKN2A) results are acceptable for enrollment, but must be confirmed through central laboratory testing. Cohort 2A: Histologically- or cytological-confirmed diagnosis of DLBCL; relapse or refractory disease after at least 1 but not more than 4 lines of prior therapy; at least 1 measurable site of disease according to the Lugano Classification. The site of disease must be greater than 1.5 centimeter (cm) in the long axis regardless of short axis measurement or greater than 1.0 cm in the short axis regardless of long axis measurement, and clearly measurable in 2 perpendicular dimensions. Cohort 2B: Pancreatic Cancer: Histologically or cytologically confirmed adenocarcinoma of the pancreas; unresectable, locally advanced (Stage III), or metastatic (Stage IV) disease; relapsed or refractory disease after at least 1 prior line of approved, systemic therapy; at least 1 measurable tumor lesion per RECIST 1.1. NSCLC: histologically or cytologically confirmed NSCLC; stage IV disease; tested for presence of echinoderm microtubule-associated protein-like 4- anaplastic lymphoma kinase (EML4-ALK) rearrangement; received at least 2 prior lines of approved, systemic therapy, of which 1 therapy has to be a platinum containing regimen or failed a first-line platinum-containing regimen in combination with an anti- progressive disease (PD1) monocloncal antibody and refused a second-line regimen despite being informed about the different therapeutic options and their specific clinical benefit by the investigator; the content of this informed consent discussion including the therapeutic options reviewed by the investigator need to be documented and the participant needs to sign a specific consent form; at least 1 measurable tumor lesion per RECIST 1.1. Transitional cell carcinoma of the Urothelium: histologically or cytologically confirmed transitional cell carcinoma (TCC) of the urothelium (urinary bladder, urethra, ureter or renal pelvis) including mixed pathology with predominantly (that is [i.e.], > 50 percent of the histopathology sample) TCC with the exception of neuroendocrine or small cell carcinoma; unresectable, locally advanced (T4b) or metastatic (lymph node or visceral) disease; relapsed or refractory disease after at least 1 prior line of approved systemic therapy; at least 1 measurable tumor lesion per RECIST 1.1.
Adequate organ function as defined by: Absolute neutrophil count (ANC) with a laboratory value of >=1.5 times 10^9 per liter (L); Hemoglobin with a laboratory value of >=9 grams per deciliter (g/dL) for solid malignancy and >=8 g/dL for Non-Hodgkin's lymphoma; Platelets with a laboratory value of >=100 times 10^9/ L; prothrombin time/ International Normalization Ratio (PT/INR) and partial thromboplastin time (PTT) with a laboratory value of <=1.5 times upper limit of normal (ULN), unless participant is receiving systemic anticoagulation (Hematologic); Albumin with a laboratory value of >=2 g/dL, total bilirubin with a laboratory value of <=1.5 times ULN, alanine aminotransferase (ALT) with a laboratory value of <=2.5 times ULN (Part 1 and 2) or <5 times ULN (Part 2 only) is acceptable for participants with documented liver metastases/tumor infiltration (Hepatic); calculated creatinine clearance by Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation or measured from 24 h urine with a laboratory value of >= 50 milliliters per min (mL/min) (Renal); Ejection fraction with a laboratory value of >=Lower limit of normal (LLN) by echocardiogram (minimum of 50 percent)/ multigated (radionuclide) angiogram (MUGA), Electrocardiogram (ECG): corrected QT (QTc) interval using Fridericia's formula (QTcF) with a laboratory value of <450 milliseconds (msec) (Cardiac).
Eastern cooperative oncology group (ECOG) performance status of 0 or 1.
Able to swallow and retain orally-administered medication.
A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies; is not a woman of childbearing potential (WOCBP) or is a WOCBP and using a contraceptive method that is highly effective, with a failure rate of <1 percent, during the intervention period and for at least 120 days, corresponding to the time needed to eliminate any study intervention(s) (example given [e.g.], 5 terminal half-lives) after the last dose of study intervention. The investigator should evaluate the effectiveness of the contraceptive method in relationship to the first dose of study intervention. A WOCBP must have a negative highly sensitive pregnancy test (urine as required by local regulations) within 7 days before the first dose of study intervention. The investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a woman with an early undetected pregnancy. Male participants are eligible to participate if they agree to the following during the intervention period and for at least 100 days, corresponding to time needed to eliminate study intervention(s) (e.g., 5 terminal half-lives) plus 90 days after the last dose of study intervention: Refrain from donating sperm plus either: Be abstinent from heterosexual or homosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis) and agree to remain abstinent or must agree to use contraception/barrier as detailed below; agree to use a male condom and should also be advised of the benefit for a female partner to use a highly effective method of contraception as a condom may break or leak when having sexual intercourse with a woman of childbearing potential who is not currently pregnant; agree to use male condom when engaging in any activity that allows for passage of ejaculate to another person.
Capable of giving signed informed consent.
Exclusion Criteria:
History of malignancy other than the disease under study. Participants who have been disease-free for 5 years, or participants with a history of completely resected non-melanoma skin cancer or successfully treated in situ carcinoma are eligible. Participants with second malignancies that are indolent or definitively treated may be enrolled even if less than 5 years have elapsed since treatment.
Primary central nervous system (CNS) tumors, Glioblastoma multiforme (GBM), symptomatic or untreated leptomeningeal or brain metastases or spinal cord compression. Participants previously treated for these conditions that have had stable CNS disease (verified with consecutive imaging studies) for >1 months, are asymptomatic and off corticosteroids, or are on stable dose of corticosteroids for at least 1 month prior to study Day 1 are permitted. Stability of brain metastases must be confirmed with imaging. Participants treated with gamma knife therapy can be enrolled 2 weeks post-procedure as long as there are no post-procedure complications/they are stable.
Any severe or uncontrolled systemic diseases (e.g., unstable or uncompensated respiratory, hepatic, renal, cardiac disease, or clinically significant bleeding episodes, or active infection).
Any serious and/or unstable pre-existing medical, psychiatric disorder, or other conditions that could interfere with participant's safety, obtaining informed consent or compliance to the study procedures, in the opinion of the Investigator.
Any clinically significant gastrointestinal (GI) abnormalities that may alter absorption such as malabsorption syndrome or major resection of the stomach and/or bowels.
History of known human immunodeficiency virus (HIV) infection or positive HIV test result at screening.
Presence of hepatitis B surface antigen (HBsAg) or positive hepatitis C antibody test result at screening to first dose of study intervention.
Any of the following cardiac abnormalities: Uncontrolled high blood pressure; any history of coronary artery disease, including acute coronary syndromes, myocardial infarction, unstable angina, and history of coronary angioplasty, or stenting; presence of a cardiac pacemaker or implanted defibrillator; atrioventricular (AV)-block (asymptomatic 2nd degree Type II or 3rd degree and any degree AV block if related to heart disease or if symptomatic), right bundle branch block (RBBB), left bundle branch block (LBBB), and any fasicular hemiblocks; A QRS interval at Screening or Baseline >110 msec; participants with any symptomatic or sustained arrhythmias (past or present), including but not limited to: Atrial fibrillation, Atrial flutter, Ventricular tachycardia, Ventricular fibrillation, Supraventricular tachycardia; Current or past congestive heart failure; Evidence of a left ventricular ejection fraction below the institutional lower limit of normal on Screening echocardiogram; Evidence of significant structural heart disease on echocardiography at Screening (including any valvular disease greater than "mild" in severity); Cardiac troponin > upper limit of the reference range at Screening.
Treatment with any local or systemic anti-neoplastic therapy or investigational anticancer agent within 14 days or 4 half-lives, whichever is longer, up to a maximum wash-out period of 28 days prior to initiation of study drug administration. Anti-androgen therapies for prostate cancer, such as bicalutamide, must be stopped 28 days prior to first dose of GSK3368715. Second-line hormone therapies such as enzalutamide or abiraterone should be stopped 14 days prior to enrolment. Participants with prostate cancer may remain on luteinizing hormone-releasing hormone (LHRH) agonists or antagonists and/or low-dose prednisone or prednisolone (up to 10 milligrams per day [mg/day]). Nitrosureas and mitomycin C must be stopped within 42 days prior to first dose of GSK3368715.
Toxicities from previous anti-cancer therapies have not resolved to Baseline or National Cancer Institute (NCI) CTCAE V5.0. <=Grade 1 (except fatigue and alopecia [permissible at any grade] and peripheral neuropathy [which must be <= Grade 2]) at the time of starting study intervention.
Major surgery (i.e. requiring general anesthesia) within 3 weeks before screening, or not fully recovered from major surgery, or major surgery planned during study participation. Planned surgical procedures to be conducted under local anesthesia are allowed.
Prior organ transplantation.
Concurrent anti-coagulation therapy. Treatment with low-molecular heparin is allowed.
Current use of a prohibited medication or planned use of any forbidden medications during intervention with GSK3368715.
History of sensitivity to any of the study medications, or components thereof or a history of drug or other allergy that, in the opinion of the investigator or Medical Monitor, contraindicates their participation.
Participant is considered high-risk for VTE as defined by either Khorana Score of greater than or equal to 3 or prior medical history of VTE.
El-Khoueiry AB, Clarke J, Neff T, Crossman T, Ratia N, Rathi C, Noto P, Tarkar A, Garrido-Laguna I, Calvo E, Rodon J, Tran B, O'Dwyer PJ, Cuker A, Abdul Razak AR. Phase 1 study of GSK3368715, a type I PRMT inhibitor, in patients with advanced solid tumors. Br J Cancer. 2023 Aug;129(2):309-317. doi: 10.1038/s41416-023-02276-0. Epub 2023 May 26.
See Also Links
Not provided
Available IPD Information
Not provided
IPD Sharing Statement Module
Plan to Share IPD
Yes
Description
IPD for this study will be made available via the Clinical Study Data Request site.
Types
Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame
IPD will be made available within 6 months of publishing the results of the primary endpoints of the study.
Access Criteria
Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
This study was terminated early during Part 1 as the benefit/risk assessment did not favor continuation of the study and therefore, Part 1: Food effect cohorts and Part 2 were not conducted. Total 31 participants were enrolled in Part 1 of the study.
Recruitment Details
This was planned as a 2-part, first time in human study in participants with solid tumors and Diffuse Large B-Cell Lymphoma (DLBCL). Part 1 was planned to include dose escalation and food effect cohorts and Part 2 was an expansion cohort.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Part 1 GSK3368715 50mg
Participants with solid relapsed/refractory tumors were administered once daily oral dose of GSK3368715 50 milligrams (mg).
FG001
Part 1 GSK3368715 100mg
Periods
Title
Milestones
Reasons Not Completed
Part 1 (Up to 28 Months)
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
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
Dec 5, 2019
Feb 8, 2022
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
No data available
No data is available for this block.
Non-Randomized
Intervention Model
Sequential Assignment
Intervention Model Description
Eligible participants will receive sequential doses of GSK3368715, administered orally once daily in Part 1 of the study and in Part 2, participants will receive RP2D determined in Part 1.
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
None (Open Label)
Masking Description
This will be an open-label study. Hence, masking will not be performed.
Who Masked
Not provided
Eligible participants with relapsed/refractory solid tumors (pancreas cancer, NSCLC, and bladder cancer) will receive RP2D of GSK3368715 established during Part 1, administered orally once daily.
Drug: GSK3368715
Part 1: GSK3368715 dose escalation
Part 2:GSK3368715 dose expansion - DLBCL participants
Part 2:GSK3368715 dose expansion-solid tumor participants
GSK3368715
Drug
GSK3368715 will be available in Immediate release (IR) white film coated tablet with dosing strengths of 50 mg, 100 mg and 250 mg to be administered orally once daily .
Part 1: GSK3368715 Food effect
Up to 28 months
Part 2: Percentage of Participants Achieving Objective Response Rate (ORR)
ORR is defined as the percentage of participants with a confirmed complete response (CR) or a partial response (PR). Participants with solid tumor were planned to be assessed per Response Criteria for Solid Tumors (RECIST) 1.1 and DLBCL participants were planned to be assessed per Lugano Criteria. This analysis was planned but not performed for Part 2 as the study was terminated during Part 1.
Up to 48 months
Up to 28 months
Part 1: Maximum Observed Plasma Concentration (Cmax) Following Administration of GSK3368715
Blood samples were collected at indicated time points. The pharmacokinetic (PK) parameters were calculated by non-compartmental analysis. PK Population included all participants in the All-Treated population from whom at least one PK sample was obtained, analyzed, and was measurable.
Pre-dose, 15, 30 minutes, 1, 1.5, 2 ,3 ,4 ,6, 8, 12, 24, 48, 72 hours post-dose on Day 1; Pre-dose,30 minutes, 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose on Day 15
Part 1: Time to Reach Cmax (Tmax) Following Administration of GSK3368715
Blood samples were collected at indicated time points. The PK parameters were calculated by non-compartmental analysis.
Pre-dose, 15, 30 minutes, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 hours post-dose on Day 1; Pre-dose,30 minutes, 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose on Day 15
Part 1: Area Under the Concentration Time Curve From Time Zero to Last Time of Quantifiable Concentration (AUC [0-t]) Following Administration of GSK3368715
Blood samples were collected at indicated time points. The PK parameters were calculated by non-compartmental analysis.
Pre-dose, 15, 30 minutes, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 hours post-dose on Day 1; Pre-dose,30 minutes, 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose on Day 15
Part 1: AUC From Time Zero Extrapolated to Infinite Time (AUC [0-infinity]) Following Administration of GSK3368715
Blood samples were collected at indicated time points. The PK parameters were calculated by non-compartmental analysis.
Pre-dose, 15, 30 minutes, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 hours post-dose on Day 1
Part 1: Area Under the Concentration-time Curve From Time Zero to the Predose of the Next Dose [AUC (0-tau)] Following Administration of GSK3368715
Blood samples were collected at indicated time points. The PK parameters were calculated by non-compartmental analysis.
Pre-dose, 30 minutes, 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose on Day 15
Part 1: Trough (Pre-dose) Concentration (Ctau) Following Administration of GSK3368715
Blood samples were collected at indicated time points. The PK parameters were calculated by non-compartmental analysis. Not applicable (NA) indicates that data could not be calculated as these were derivate values which were below the lower limit of quantification.
Pre-dose on Day 1 and Day 15
Part 1: Time Invariance Ratio Following Administration of GSK3368715
Blood samples were collected at indicated time points. The PK parameters were calculated by non-compartmental analysis. Time invariance was calculated as the ratio of AUC(0-24) on Day 15 / AUC (0-infinity) on Day 1 for GSK3368715.
Pre-dose, 15, 30 minutes, 1 ,1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 hours post-dose on Day 1; Pre-dose, 30 minutes,1, 2, 3, 4, 6, 8, 12, 24 hours post-dose on Day 15
Part 1: Accumulation Ratio Following Administration of GSK3368715
Blood samples were collected at indicated time points. The PK parameters were calculated by non-compartmental analysis. Accumulation ratio (AR) was calculated as the ratio of AUC(0-24) on Day 15/Day 1 for GSK3368715.
Pre-dose, 15, 30 minutes, 1 ,1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 hours post-dose on Day 1; Pre-dose, 30 minutes, 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose on Day 15
Part 1: Food Effect Cohorts: Cmax Following Administration of GSK3368715
Blood samples were planned to be collected at indicated time points in food effect cohorts (fasted followed by fed state and fed followed by fasted state). Samples were not collected due to early termination of study during Part 1; therefore, no analysis could be performed.
Pre-dose, 15, 30 minutes, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 hours post-dose on Day 1; Pre-dose, 1 and 4 hours post dose on Day 8, Pre-dose, 30 minutes, 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose on Day 15
Part 1: Food Effect Cohorts: Tmax Following Administration of GSK3368715
Blood samples were planned to be collected at indicated time points in food effect cohorts (fasted followed by fed state and fed followed by fasted state). Samples were not collected due to early termination of the study during Part 1; therefore, no analysis could be performed.
Pre-dose, 15, 30 minutes, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 hours post-dose on Day 1; Pre-dose, 1 and 4 hours post dose on Day 8, Pre-dose, 30 minutes, 1 ,2, 3, 4, 6, 8, 12, 24 hours post-dose on Day 15
Part 1: Food Effect Cohorts: AUC (0-t) Following Administration of GSK3368715
Blood samples were planned to be collected at indicated time points in food effect cohorts (fasted followed by fed state and fed followed by fasted state). Samples were not collected due to early termination of the study during Part 1; therefore, no analysis could be performed.
Pre-dose, 15, 30 minutes, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 hours post-dose on Day 1; Pre-dose, 1 and 4 hours post dose on Day 8, Pre-dose,30 minutes, 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose on Day 15
Part 1: Food Effect Cohorts: AUC (0-infinity) Following Administration of GSK3368715
Blood samples were planned to be collected at indicated time points in food effect cohorts (fasted followed by fed state and fed followed by fasted state). Samples were not collected due to early termination of the study during Part 1; therefore, no analysis could be performed.
Pre-dose, 15, 30 minutes, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 hours post-dose on Day 1; Pre-dose, 1 and 4 hours post dose on Day 8, Pre-dose,30 minutes,1, 2, 3, 4, 6, 8, 12, 24 hours post-dose on Day 15
Part 1: Food Effect Cohorts: AUC (0-tau) Following Administration of GSK3368715
Blood samples were planned to be collected at indicated time points in food effect cohorts (fasted followed by fed state and fed followed by fasted state). Samples were not collected due to early termination of the study during Part 1; therefore, no analysis could be performed.
Pre-dose, 15, 30 minutes, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 hours post-dose on Day 1; Pre-dose, 1 and 4 hours post dose on Day 8, Pre-dose, 30 minutes, 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose on Day 15
Part 2: Number of Participants With Non-SAEs and SAEs
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. Any untoward event resulting in death, life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, congenital anomaly/birth defect or any other situation according to medical or scientific judgment is categorized as serious adverse event (SAE). This analysis was planned but not performed for Part 2 as the study was terminated early during Part 1.
Up to 48 months
Part 2: Number of Participants With AEs by Severity Grades
All adverse events were analyzed using National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5.0. Graded from Grade 1: mild asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated, Grade 2: Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental activities of daily living (ADL), Grade 3: Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care ADL, Grade 4: Life-threatening consequences; urgent intervention indicated, Grade 5: death related AE. Higher grade indicates more severe condition. Number of participants with maximum severity grades were presented. This analysis was planned but not performed for Part 2 as the study was terminated early during Part 1.
Up to 48 months
Part 2: Progression-free Survival (PFS)
PFS is defined as the time from the first dose of study intervention to disease progression or death due to any cause, whichever occurs earlier. This analysis was planned but not performed for Part 2 as the study was terminated early during Part 1.
Up to 48 months
Part 2: Cmax Following Administration of GSK3368715
Blood samples were planned to be collected for PK analysis of GSK3368715. This analysis was planned but not performed for Part 2 as the study was terminated early during Part 1.
Pre-dose, 15, 30 minutes, 1, 1.5 ,2 ,3 ,4 ,6, 8, 12, 24, 48, 72 hours post-dose on Day 1; Pre-dose,30 minutes, 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose on Day 15
Part 2: Tmax Following Administration of GSK3368715
Blood samples were planned to be collected for PK analysis of GSK3368715. This analysis was planned but not performed for Part 2 as the study was terminated early during Part 1.
Pre-dose, 15, 30 minutes, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 hours post-dose on Day 1; Pre-dose,30 minutes, 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose on Day 15
Part 2: AUC (0-t) Following Administration of GSK3368715
Blood samples were planned to be collected for PK analysis of GSK3368715. This analysis was planned but not performed for Part 2 as the study was terminated early during Part 1.
Pre-dose, 15, 30 minutes, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 hours post-dose on Day 1; Pre-dose,30 minutes, 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose on Day 15
Part 2: AUC (0-infinity) Following Administration of GSK3368715
Blood samples were planned to be collected for PK analysis of GSK3368715 . This analysis was planned but not performed for Part 2 as the study was terminated early during Part 1.
Pre-dose, 15, 30 minutes, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 hours post-dose on Day 1
Part 2: AUC (0-tau) Following Administration of GSK3368715
Blood samples were planned to be collected for PK analysis of GSK3368715. This analysis was planned but not performed for Part 2 as the study was terminated early during Part 1.
Pre-dose, 30 minutes, 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose on Day 15
Part 2: Ctau Following Administration of GSK3368715
Blood samples were planned to be collected for pharmacokinetic analysis of GSK3368715. This analysis was planned but not performed for Part 2 as the study was terminated early during Part 1.
Pre-dose on Day 1 and Day 15
Part 2: Time Invariance Ratio Following Administration of GSK3368715
Blood samples were planned to be collected for pharmacokinetic analysis of GSK3368715. This analysis was planned but not performed for Part 2 as the study was terminated early during Part 1.
Pre-dose, 15, 30 minutes, 1 ,1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 hours post-dose on Day 1; Pre-dose, 30 minutes,1, 2, 3, 4, 6, 8, 12, 24 hours post-dose on Day 15
Part 2: Accumulation Ratio Following Administration of GSK3368715
Blood samples were planned to be collected for PK analysis of GSK3368715. This analysis was planned but not performed for Part 2 as the study was terminated early during Part 1.
Pre-dose, 15, 30 minutes, 1 ,1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 hours post-dose on Day 1; Pre-dose, 30 minutes, 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose on Day 15
Newport Beach
California
92663
United States
GSK Investigational Site
Philadelphia
Pennsylvania
19104-4206
United States
GSK Investigational Site
Houston
Texas
77030
United States
GSK Investigational Site
Salt Lake City
Utah
84112
United States
GSK Investigational Site
Melbourne
Victoria
3000
Australia
GSK Investigational Site
Toronto
Ontario
M5G 1X5
Canada
GSK Investigational Site
Barcelona
08035
Spain
GSK Investigational Site
Madrid
28050
Spain
Participants with solid relapsed/refractory tumors were administered once daily oral dose of GSK3368715 100mg.
FG002
Part 1 GSK3368715 200mg
Participants with solid relapsed/refractory tumors were administered once daily oral dose of GSK3368715 200mg.
FG003
Part 1:Food Effect Cohort: GSK3368715 Fasted Followed by Fed
Participants with solid relapsed/refractory tumors were planned to receive once daily oral dose of GSK3368715 with a tablet formulation in the fasted state followed by fed state at or near the recommended Phase II dose (RP2D).
FG004
Part 1:Food Effect Cohort: GSK3368715 Fed Followed by Fasted
Participants with solid relapsed/refractory tumors were planned to receive once daily oral dose of GSK3368715 with a tablet formulation in the fed state followed by fasted state at or near the RP2D.
FG005
Part 2 GSK3368715 Expansion Cohort
Participants with DLBCL were planned to receive recommended Phase II dose (RP2D) based on Part 1 data.
FG0003 subjects
FG00116 subjects
FG00212 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
NOT COMPLETED
FG0003 subjects
FG00116 subjects
FG00212 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
Type
Comment
Reasons
Adverse Event
FG0000 subjects
FG0011 subjects
FG0023 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
Other
FG0000 subjects
FG0011 subjects
FG0021 subjects
FG0030 subjects
FG004
Disease Progression
FG0002 subjects
FG00114 subjects
FG0027 subjects
FG0030 subjects
FG004
Physician Decision
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG004
Withdrawal by Subject
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Part 2 (Up to 48 Months)
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Study was terminated early during Part 1 as the benefit/risk assessment did not favor continuation of the study, therefore Part 1: Food effect cohorts and Part 2 were not conducted.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Part 1 GSK3368715 50mg
Participants with solid relapsed/refractory tumors were administered once daily oral dose of GSK3368715 50 milligrams (mg).
BG001
Part 1 GSK3368715 100mg
Participants with solid relapsed/refractory tumors were administered once daily oral dose of GSK3368715 100mg.
BG002
Part 1 GSK3368715 200mg
Participants with solid relapsed/refractory tumors were administered once daily oral dose of GSK3368715 200mg.
BG003
Part 1:Food Effect Cohort: GSK3368715 Fasted Followed by Fed
Participants with solid relapsed/refractory tumors were planned to receive once daily oral dose of GSK3368715 with a tablet formulation in the fasted state followed by fed state at or near the recommended Phase II dose (RP2D).
BG004
Part 1:Food Effect Cohort: GSK3368715 Fed Followed by Fasted
Participants with solid relapsed/refractory tumors were planned to receive once daily oral dose of GSK3368715 with a tablet formulation in the fed state followed by fasted state at or near the RP2D.
BG005
Part 2 GSK3368715 Expansion Cohort
Participants with DLBCL were planned to receive recommended Phase II dose (RP2D) based on Part 1 data.
BG006
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG0003
BG00116
BG00212
BG0030
BG0040
BG0050
BG00631
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Study was terminated early during Part 1 as the benefit/risk assessment did not favor continuation of the study, therefore Part 1: Food effect cohorts and Part 2 were not conducted.
Mean
Standard Deviation
Years
Title
Denominators
Categories
Title
Measurements
BG00068.0± 6.56
BG00155.5± 15.12
BG00259.7± 10.89
BG006
Sex: Female, Male
Study was terminated early during Part 1 as the benefit/risk assessment did not favor continuation of the study, therefore Part 1: Food effect cohorts and Part 2 were not conducted.
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0002
BG0014
Race/Ethnicity, Customized
Study was terminated early during Part 1 as the benefit/risk assessment did not favor continuation of the study, therefore Part 1: Food effect cohorts and Part 2 were not conducted.
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Asian - East Asian Heritage
BG0000
BG001
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
Part 1: Number of Participants With Dose Limiting Toxicities (DLTs)
A DLT is considered by the investigator to be clinically relevant,attributed event during the first 21days of intervention meeting the following criteria:Non-hematologic toxicity:Aspartate Aminotransferase(AST)/Alanine Aminotransferase(ALT) Grade 3/4,ALT>=5 times Upper limit of Normal(ULN),ALT>=3times ULN(>=4 weeks),ALT>=3 times ULN plus(+)bilirubin>=2 times ULN,ALT >= 3 times ULN+liver symptoms or International Normalization Ratio(INR)>1.5.Nausea:Grade 3;Vomiting or diarrhea:Grade3/4(>3days);Fatigue:Grade 3(>5days).Hypertension:Uncontrolled Grade 3/4.Electrocardiogram(ECG)-change:>20 milliseconds(msec) QRS extension.Lab abnormality:uncontrolled Grade3(>3days)/Grade4.Hematologic toxicity:Neutropenia:uncontrolled Grade3(>3days)/febrile neutropenia/Grade 4.Thrombocytopenia:uncontrolled Grade 3(>3days)/Grade 3(clinically significant Hemorrhage)/Grade 4.Venous thromboembolism (VTE):Grade2 needing systemic anticoagulation/Grade>=3 during the first 8 weeks or if sooner,study discontinuation
All-Treated Population included all participants who received at least one dose of GSK3368715. Data was not collected for Part 1: Food Effect Cohorts, as the study was terminated early during Part 1 and hence no participants were enrolled in Part 1: Food Effect Cohorts
Posted
Count of Participants
Participants
Up to 21 days
ID
Title
Description
OG000
Part 1 GSK3368715 50mg
Participants with solid relapsed/refractory tumors were administered once daily oral dose of GSK3368715 50 milligrams (mg).
OG001
Part 1 GSK3368715 100mg
Participants with solid relapsed/refractory tumors were administered once daily oral dose of GSK3368715 100mg.
OG002
Part 1 GSK3368715 200mg
Participants with solid relapsed/refractory tumors were administered once daily oral dose of GSK3368715 200mg.
OG003
Part 1: Food Effect Cohort: GSK3368715 Fasted Followed by Fed
Participants with solid relapsed/refractory tumors were planned to receive once daily oral dose of GSK3368715 with a tablet formulation in the fasted state followed by fed state at or near the recommended Phase II dose (RP2D).
OG004
Part 1: Food Effect Cohort: GSK3368715 Fed Followed by Fasted
Participants with solid relapsed/refractory tumors were planned to receive once daily oral dose of GSK3368715 with a tablet formulation in the fed state followed by fasted state at or near the RP2D.
Units
Counts
Participants
OG0003
OG00116
OG00212
OG003
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0023
Primary
Part 1: Number of Participants With Non-Serious Adverse Events (Non-SAEs) and SAEs
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. Any untoward event resulting in death, life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, congenital anomaly/birth defect or any other situation according to medical or scientific judgment is categorized as SAE.
All-Treated Population. Data was not collected for Part 1: Food Effect Cohorts, as the study was terminated early during Part 1 and hence no participants were enrolled in Part 1: Food Effect Cohorts
Posted
Count of Participants
Participants
Up to 28 months
ID
Title
Description
OG000
Part 1 GSK3368715 50mg
Participants with solid relapsed/refractory tumors were administered once daily oral dose of GSK3368715 50 milligrams (mg).
OG001
Part 1 GSK3368715 100mg
Participants with solid relapsed/refractory tumors were administered once daily oral dose of GSK3368715 100mg.
OG002
Part 1 GSK3368715 200mg
Participants with solid relapsed/refractory tumors were administered once daily oral dose of GSK3368715 200mg.
Primary
Part 1: Number of Participants With AEs by Severity Grades
All adverse events were analyzed using National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5.0. Graded from Grade 1: mild asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated, Grade 2: Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental activities of daily living (ADL), Grade 3: Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care ADL, Grade 4: Life-threatening consequences; urgent intervention indicated, Grade 5: death related AE. Higher grade indicates more severe condition. Number of participants with maximum severity grades are presented.
All-Treated Population. Data was not collected for Part 1: Food Effect Cohorts, as the study was terminated early during Part 1 and hence no participants were enrolled in Part 1: Food Effect Cohorts
Posted
Count of Participants
Participants
Up to 28 months
ID
Title
Description
OG000
Part 1 GSK3368715 50mg
Participants with solid relapsed/refractory tumors were administered once daily oral dose of GSK3368715 50 milligrams (mg).
OG001
Part 1 GSK3368715 100mg
Participants with solid relapsed/refractory tumors were administered once daily oral dose of GSK3368715 100mg.
Primary
Part 2: Percentage of Participants Achieving Objective Response Rate (ORR)
ORR is defined as the percentage of participants with a confirmed complete response (CR) or a partial response (PR). Participants with solid tumor were planned to be assessed per Response Criteria for Solid Tumors (RECIST) 1.1 and DLBCL participants were planned to be assessed per Lugano Criteria. This analysis was planned but not performed for Part 2 as the study was terminated during Part 1.
All-Treated Population. Data was not collected in Part 2 as the study was terminated early during Part 1 and hence no participant was enrolled in Part 2.
Posted
Up to 48 months
ID
Title
Description
OG000
Part 2 GSK3368715 Expansion Cohort
Participants with DLBCL were planned to receive recommended Phase II dose (RP2D) based on Part 1 data.
Units
Counts
Participants
OG000
Secondary
Part 1: Percentage of Participants Achieving Best Overall Response Rate
Overall response rate is defined as the percentage of participants with a confirmed complete response (CR) or a partial response (PR). Participants with solid tumor were assessed per Response Criteria for Solid Tumors (RECIST) 1.1 and DLBCL participants were assessed per Lugano Criteria. The best ORR was recorded from the start of the intervention until disease progression/recurrence and was determined based on the investigator's assessment of response at each time point. The percentage of participants achieving best overall response rate have been presented.
All Treated Population. Data was not collected for Part 1: Food Effect Cohorts, as the study was terminated early during Part 1 and hence no participants were enrolled in Part 1: Food Effect Cohorts
Posted
Number
Percentage of participants
Up to 28 months
ID
Title
Description
OG000
Part 1 GSK3368715 50mg
Participants with solid relapsed/refractory tumors were administered once daily oral dose of GSK3368715 50 milligrams (mg).
OG001
Part 1 GSK3368715 100mg
Participants with solid relapsed/refractory tumors were administered once daily oral dose of GSK3368715 100mg.
OG002
Part 1 GSK3368715 200mg
Secondary
Part 1: Maximum Observed Plasma Concentration (Cmax) Following Administration of GSK3368715
Blood samples were collected at indicated time points. The pharmacokinetic (PK) parameters were calculated by non-compartmental analysis. PK Population included all participants in the All-Treated population from whom at least one PK sample was obtained, analyzed, and was measurable.
PK Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles). Data was not collected for Part 1: Food Effect Cohorts, as the study was terminated early during Part 1 and hence no participants were enrolled in Part 1: Food Effect Cohorts
Posted
Geometric Mean
Geometric Coefficient of Variation
Nanograms per milliliter
Pre-dose, 15, 30 minutes, 1, 1.5, 2 ,3 ,4 ,6, 8, 12, 24, 48, 72 hours post-dose on Day 1; Pre-dose,30 minutes, 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose on Day 15
ID
Title
Description
OG000
Part 1 GSK3368715 50mg
Participants with solid relapsed/refractory tumors were administered once daily oral dose of GSK3368715 50 milligrams (mg).
OG001
Part 1 GSK3368715 100mg
Participants with solid relapsed/refractory tumors were administered once daily oral dose of GSK3368715 100mg.
OG002
Part 1 GSK3368715 200mg
Secondary
Part 1: Time to Reach Cmax (Tmax) Following Administration of GSK3368715
Blood samples were collected at indicated time points. The PK parameters were calculated by non-compartmental analysis.
PK Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).Data was not collected for Part 1: Food Effect Cohorts, as the study was terminated early during Part 1 and hence no participants were enrolled in Part 1: Food Effect Cohorts
Posted
Geometric Mean
Geometric Coefficient of Variation
Hours
Pre-dose, 15, 30 minutes, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 hours post-dose on Day 1; Pre-dose,30 minutes, 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose on Day 15
ID
Title
Description
OG000
Part 1 GSK3368715 50mg
Participants with solid relapsed/refractory tumors were administered once daily oral dose of GSK3368715 50 milligrams (mg).
OG001
Part 1 GSK3368715 100mg
Participants with solid relapsed/refractory tumors were administered once daily oral dose of GSK3368715 100mg.
OG002
Part 1 GSK3368715 200mg
Participants with solid relapsed/refractory tumors were administered once daily oral dose of GSK3368715 200mg.
Secondary
Part 1: Area Under the Concentration Time Curve From Time Zero to Last Time of Quantifiable Concentration (AUC [0-t]) Following Administration of GSK3368715
Blood samples were collected at indicated time points. The PK parameters were calculated by non-compartmental analysis.
PK Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).Data was not collected for Part 1: Food Effect Cohorts, as the study was terminated early during Part 1 and hence no participants were enrolled in Part 1: Food Effect Cohorts
Posted
Geometric Mean
Geometric Coefficient of Variation
Hour*nanogram per milliliter
Pre-dose, 15, 30 minutes, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 hours post-dose on Day 1; Pre-dose,30 minutes, 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose on Day 15
ID
Title
Description
OG000
Part 1 GSK3368715 50mg
Participants with solid relapsed/refractory tumors were administered once daily oral dose of GSK3368715 50 milligrams (mg).
OG001
Part 1 GSK3368715 100mg
Participants with solid relapsed/refractory tumors were administered once daily oral dose of GSK3368715 100mg.
OG002
Part 1 GSK3368715 200mg
Secondary
Part 1: AUC From Time Zero Extrapolated to Infinite Time (AUC [0-infinity]) Following Administration of GSK3368715
Blood samples were collected at indicated time points. The PK parameters were calculated by non-compartmental analysis.
PK Population.Only those participants (par) with data available at specified data points were analyzed.Data not collected for Part (P)1:Food Effect Cohorts (FEC),as study was terminated early during P1;hence no par were enrolled in P1:FEC.AUC(0-infinity) could not be calculated for par in "P1 GSK3368715 50mg" arm,as atleast 3 data points are required in terminal elimination phase within same par;this criteria could not be fulfilled due to insufficient data above limit of quantification
Posted
Geometric Mean
Geometric Coefficient of Variation
Hour*nanogram per milliliter
Pre-dose, 15, 30 minutes, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 hours post-dose on Day 1
ID
Title
Description
OG000
Part 1 GSK3368715 50mg
Participants with solid relapsed/refractory tumors were administered once daily oral dose of GSK3368715 50 milligrams (mg).
OG001
Part 1 GSK3368715 100mg
Participants with solid relapsed/refractory tumors were administered once daily oral dose of GSK3368715 100mg.
OG002
Part 1 GSK3368715 200mg
Secondary
Part 1: Area Under the Concentration-time Curve From Time Zero to the Predose of the Next Dose [AUC (0-tau)] Following Administration of GSK3368715
Blood samples were collected at indicated time points. The PK parameters were calculated by non-compartmental analysis.
PK Population. Only those participants with data available at the specified data points were analyzed. Data was not collected for Part 1: Food Effect Cohorts, as the study was terminated early during Part 1 and hence no participants were enrolled in Part 1: Food Effect Cohorts
Posted
Geometric Mean
Geometric Coefficient of Variation
Hour*nanogram per milliliter
Pre-dose, 30 minutes, 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose on Day 15
ID
Title
Description
OG000
Part 1 GSK3368715 50mg
Participants with solid relapsed/refractory tumors were administered once daily oral dose of GSK3368715 50 milligrams (mg).
OG001
Part 1 GSK3368715 100mg
Participants with solid relapsed/refractory tumors were administered once daily oral dose of GSK3368715 100mg.
OG002
Part 1 GSK3368715 200mg
Participants with solid relapsed/refractory tumors were administered once daily oral dose of GSK3368715 200mg.
Secondary
Part 1: Trough (Pre-dose) Concentration (Ctau) Following Administration of GSK3368715
Blood samples were collected at indicated time points. The PK parameters were calculated by non-compartmental analysis. Not applicable (NA) indicates that data could not be calculated as these were derivate values which were below the lower limit of quantification.
PK Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles). Data was not collected for Part 1: Food Effect Cohorts, as the study was terminated early during Part 1 and hence no participants were enrolled in Part 1: Food Effect Cohorts
Posted
Geometric Mean
Geometric Coefficient of Variation
Nanogram per milliliter
Pre-dose on Day 1 and Day 15
ID
Title
Description
OG000
Part 1 GSK3368715 50mg
Participants with solid relapsed/refractory tumors were administered once daily oral dose of GSK3368715 50 milligrams (mg).
OG001
Part 1 GSK3368715 100mg
Participants with solid relapsed/refractory tumors were administered once daily oral dose of GSK3368715 100mg.
OG002
Part 1 GSK3368715 200mg
Participants with solid relapsed/refractory tumors were administered once daily oral dose of GSK3368715 200mg.
Secondary
Part 1: Time Invariance Ratio Following Administration of GSK3368715
Blood samples were collected at indicated time points. The PK parameters were calculated by non-compartmental analysis. Time invariance was calculated as the ratio of AUC(0-24) on Day 15 / AUC (0-infinity) on Day 1 for GSK3368715.
PK Population. Only those participants with data available at the specified data points were analyzed. Data was not collected for Part 1: Food Effect Cohorts, as the study was terminated early during Part 1 and hence no participants were enrolled in Part 1: Food Effect Cohorts. Time invariance computation is dependent on AUC(0-infinity) and since AUC(0-infinity) could not be computed for participants in "Part 1 GSK3368715 50mg" arm, time invariance was not computable as well.
Posted
Geometric Mean
Geometric Coefficient of Variation
Ratio
Pre-dose, 15, 30 minutes, 1 ,1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 hours post-dose on Day 1; Pre-dose, 30 minutes,1, 2, 3, 4, 6, 8, 12, 24 hours post-dose on Day 15
ID
Title
Description
OG000
Part 1 GSK3368715 50mg
Participants with solid relapsed/refractory tumors were administered once daily oral dose of GSK3368715 50 milligrams (mg).
OG001
Part 1 GSK3368715 100mg
Participants with solid relapsed/refractory tumors were administered once daily oral dose of GSK3368715 100mg.
OG002
Secondary
Part 1: Accumulation Ratio Following Administration of GSK3368715
Blood samples were collected at indicated time points. The PK parameters were calculated by non-compartmental analysis. Accumulation ratio (AR) was calculated as the ratio of AUC(0-24) on Day 15/Day 1 for GSK3368715.
PK Population.Only those participants with data available at the specified data points were analyzed. Data was not collected for Part 1: Food Effect Cohorts,as study was terminated early during Part 1 and hence no participants were enrolled in Part 1: Food Effect Cohorts. Accumulation ratio could not be derived for "Part 1 GSK3368715 50mg" arm because there were no participant with AUC(0-24) values at both Day 1 and Day 15; hence, paired results were not available to calculate Accumulation ratio
Posted
Geometric Mean
Geometric Coefficient of Variation
Ratio
Pre-dose, 15, 30 minutes, 1 ,1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 hours post-dose on Day 1; Pre-dose, 30 minutes, 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose on Day 15
ID
Title
Description
OG000
Part 1 GSK3368715 50mg
Participants with solid relapsed/refractory tumors were administered once daily oral dose of GSK3368715 50 milligrams (mg).
OG001
Part 1 GSK3368715 100mg
Participants with solid relapsed/refractory tumors were administered once daily oral dose of GSK3368715 100mg.
OG002
Secondary
Part 1: Food Effect Cohorts: Cmax Following Administration of GSK3368715
Blood samples were planned to be collected at indicated time points in food effect cohorts (fasted followed by fed state and fed followed by fasted state). Samples were not collected due to early termination of study during Part 1; therefore, no analysis could be performed.
PK Population. Data was not collected for Part 1: Food Effect Cohorts, as the study was terminated early during Part 1 and hence no participants were enrolled in Part 1: Food Effect Cohorts
Posted
Pre-dose, 15, 30 minutes, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 hours post-dose on Day 1; Pre-dose, 1 and 4 hours post dose on Day 8, Pre-dose, 30 minutes, 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose on Day 15
ID
Title
Description
OG000
Part 1:Food Effect Cohort: GSK3368715 Fasted Followed by Fed
Participants with solid relapsed/refractory tumors were planned to receive once daily oral dose of GSK3368715 with a tablet formulation in the fasted state followed by fed state at or near the recommended Phase II dose (RP2D).
OG001
Part 1:Food Effect Cohort: GSK3368715 Fed Followed by Fasted
Participants with solid relapsed/refractory tumors were planned to receive once daily oral dose of GSK3368715 with a tablet formulation in the fed state followed by fasted state at or near the RP2D
Secondary
Part 1: Food Effect Cohorts: Tmax Following Administration of GSK3368715
Blood samples were planned to be collected at indicated time points in food effect cohorts (fasted followed by fed state and fed followed by fasted state). Samples were not collected due to early termination of the study during Part 1; therefore, no analysis could be performed.
PK Population. Data was not collected for Part 1: Food Effect Cohorts, as the study was terminated early during Part 1 and hence no participants were enrolled in Part 1: Food Effect Cohorts.
Posted
Pre-dose, 15, 30 minutes, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 hours post-dose on Day 1; Pre-dose, 1 and 4 hours post dose on Day 8, Pre-dose, 30 minutes, 1 ,2, 3, 4, 6, 8, 12, 24 hours post-dose on Day 15
ID
Title
Description
OG000
Part 1:Food Effect Cohort: GSK3368715 Fasted Followed by Fed
Participants with solid relapsed/refractory tumors were planned to receive once daily oral dose of GSK3368715 with a tablet formulation in the fasted state followed by fed state at or near the recommended Phase II dose (RP2D).
OG001
Part 1:Food Effect Cohort: GSK3368715 Fed Followed by Fasted
Participants with solid relapsed/refractory tumors were planned to receive once daily oral dose of GSK3368715 with a tablet formulation in the fed state followed by fasted state at or near the RP2D
Secondary
Part 1: Food Effect Cohorts: AUC (0-t) Following Administration of GSK3368715
Blood samples were planned to be collected at indicated time points in food effect cohorts (fasted followed by fed state and fed followed by fasted state). Samples were not collected due to early termination of the study during Part 1; therefore, no analysis could be performed.
PK Population. Data was not collected for Part 1: Food Effect Cohorts, as the study was terminated early during Part 1 and hence no participants were enrolled in Part 1: Food Effect Cohorts.
Posted
Pre-dose, 15, 30 minutes, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 hours post-dose on Day 1; Pre-dose, 1 and 4 hours post dose on Day 8, Pre-dose,30 minutes, 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose on Day 15
ID
Title
Description
OG000
Part 1:Food Effect Cohort: GSK3368715 Fasted Followed by Fed
Participants with solid relapsed/refractory tumors were planned to receive once daily oral dose of GSK3368715 with a tablet formulation in the fasted state followed by fed state at or near the recommended Phase II dose (RP2D).
OG001
Part 1:Food Effect Cohort: GSK3368715 Fed Followed by Fasted
Participants with solid relapsed/refractory tumors were planned to receive once daily oral dose of GSK3368715 with a tablet formulation in the fed state followed by fasted state at or near the RP2D
Secondary
Part 1: Food Effect Cohorts: AUC (0-infinity) Following Administration of GSK3368715
Blood samples were planned to be collected at indicated time points in food effect cohorts (fasted followed by fed state and fed followed by fasted state). Samples were not collected due to early termination of the study during Part 1; therefore, no analysis could be performed.
PK Population. Data was not collected for Part 1: Food Effect Cohorts, as the study was terminated early during Part 1 and hence no participants were enrolled in Part 1: Food Effect Cohorts.
Posted
Pre-dose, 15, 30 minutes, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 hours post-dose on Day 1; Pre-dose, 1 and 4 hours post dose on Day 8, Pre-dose,30 minutes,1, 2, 3, 4, 6, 8, 12, 24 hours post-dose on Day 15
ID
Title
Description
OG000
Part 1:Food Effect Cohort: GSK3368715 Fasted Followed by Fed
Participants with solid relapsed/refractory tumors were planned to receive once daily oral dose of GSK3368715 with a tablet formulation in the fasted state followed by fed state at or near the recommended Phase II dose (RP2D).
OG001
Part 1:Food Effect Cohort: GSK3368715 Fed Followed by Fasted
Participants with solid relapsed/refractory tumors were planned to receive once daily oral dose of GSK3368715 with a tablet formulation in the fed state followed by fasted state at or near the RP2D
Secondary
Part 1: Food Effect Cohorts: AUC (0-tau) Following Administration of GSK3368715
Blood samples were planned to be collected at indicated time points in food effect cohorts (fasted followed by fed state and fed followed by fasted state). Samples were not collected due to early termination of the study during Part 1; therefore, no analysis could be performed.
PK Population. Data was not collected for Part 1: Food Effect Cohorts, as the study was terminated early during Part 1 and hence no participants were enrolled in Part 1: Food Effect Cohorts.
Posted
Pre-dose, 15, 30 minutes, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 hours post-dose on Day 1; Pre-dose, 1 and 4 hours post dose on Day 8, Pre-dose, 30 minutes, 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose on Day 15
ID
Title
Description
OG000
Part 1:Food Effect Cohort: GSK3368715 Fasted Followed by Fed
Participants with solid relapsed/refractory tumors were planned to receive once daily oral dose of GSK3368715 with a tablet formulation in the fasted state followed by fed state at or near the recommended Phase II dose (RP2D).
OG001
Part 1:Food Effect Cohort: GSK3368715 Fed Followed by Fasted
Participants with solid relapsed/refractory tumors were planned to receive once daily oral dose of GSK3368715 with a tablet formulation in the fed state followed by fasted state at or near the RP2D
Secondary
Part 2: Number of Participants With Non-SAEs and SAEs
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. Any untoward event resulting in death, life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, congenital anomaly/birth defect or any other situation according to medical or scientific judgment is categorized as serious adverse event (SAE). This analysis was planned but not performed for Part 2 as the study was terminated early during Part 1.
All Treated Population. Data was not collected as the study was terminated early during Part 1 and hence no participants were enrolled in Part 2.
Posted
Up to 48 months
ID
Title
Description
OG000
Part 2 GSK3368715 Expansion Cohort
Participants with DLBCL were planned to receive recommended Phase II dose (RP2D) based on Part 1 data.
Units
Counts
Participants
OG000
Secondary
Part 2: Number of Participants With AEs by Severity Grades
All adverse events were analyzed using National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5.0. Graded from Grade 1: mild asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated, Grade 2: Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental activities of daily living (ADL), Grade 3: Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care ADL, Grade 4: Life-threatening consequences; urgent intervention indicated, Grade 5: death related AE. Higher grade indicates more severe condition. Number of participants with maximum severity grades were presented. This analysis was planned but not performed for Part 2 as the study was terminated early during Part 1.
All Treated Population. Data was not collected as the study was terminated early during Part 1 and hence no participants were enrolled in Part 2.
Posted
Up to 48 months
ID
Title
Description
OG000
Part 2 GSK3368715 Expansion Cohort
Participants with DLBCL were planned to receive recommended Phase II dose (RP2D) based on Part 1 data.
Units
Counts
Participants
Secondary
Part 2: Progression-free Survival (PFS)
PFS is defined as the time from the first dose of study intervention to disease progression or death due to any cause, whichever occurs earlier. This analysis was planned but not performed for Part 2 as the study was terminated early during Part 1.
All Treated Population. Data was not collected as the study was terminated early during Part 1 and hence no participants were enrolled in Part 2.
Posted
Up to 48 months
ID
Title
Description
OG000
Part 2 GSK3368715 Expansion Cohort
Participants with DLBCL were planned to receive recommended Phase II dose (RP2D) based on Part 1 data.
Units
Counts
Participants
OG000
Secondary
Part 2: Cmax Following Administration of GSK3368715
Blood samples were planned to be collected for PK analysis of GSK3368715. This analysis was planned but not performed for Part 2 as the study was terminated early during Part 1.
PK Population. Data was not collected as the study was terminated early during Part 1 and hence no participants were enrolled in Part 2.
Posted
Pre-dose, 15, 30 minutes, 1, 1.5 ,2 ,3 ,4 ,6, 8, 12, 24, 48, 72 hours post-dose on Day 1; Pre-dose,30 minutes, 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose on Day 15
ID
Title
Description
OG000
Part 2 GSK3368715 Expansion Cohort
Participants with DLBCL were planned to receive recommended Phase II dose (RP2D) based on Part 1 data.
Units
Counts
Participants
OG000
Secondary
Part 2: Tmax Following Administration of GSK3368715
Blood samples were planned to be collected for PK analysis of GSK3368715. This analysis was planned but not performed for Part 2 as the study was terminated early during Part 1.
PK Population. Data was not collected as the study was terminated early during Part 1 and hence no participants were enrolled in Part 2.
Posted
Pre-dose, 15, 30 minutes, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 hours post-dose on Day 1; Pre-dose,30 minutes, 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose on Day 15
ID
Title
Description
OG000
Part 2 GSK3368715 Expansion Cohort
Participants with DLBCL were planned to receive recommended Phase II dose (RP2D) based on Part 1 data.
Units
Counts
Participants
OG000
Secondary
Part 2: AUC (0-t) Following Administration of GSK3368715
Blood samples were planned to be collected for PK analysis of GSK3368715. This analysis was planned but not performed for Part 2 as the study was terminated early during Part 1.
PK Population. Data was not collected as the study was terminated early during Part 1 and hence no participants were enrolled in Part 2.
Posted
Pre-dose, 15, 30 minutes, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 hours post-dose on Day 1; Pre-dose,30 minutes, 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose on Day 15
ID
Title
Description
OG000
Part 2 GSK3368715 Expansion Cohort
Participants with DLBCL were planned to receive recommended Phase II dose (RP2D) based on Part 1 data.
Units
Counts
Participants
OG000
Secondary
Part 2: AUC (0-infinity) Following Administration of GSK3368715
Blood samples were planned to be collected for PK analysis of GSK3368715 . This analysis was planned but not performed for Part 2 as the study was terminated early during Part 1.
PK Population. Data was not collected as the study was terminated early during Part 1 and hence no participants were enrolled in Part 2.
Posted
Pre-dose, 15, 30 minutes, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 hours post-dose on Day 1
ID
Title
Description
OG000
Part 2 GSK3368715 Expansion Cohort
Participants with DLBCL were planned to receive recommended Phase II dose (RP2D) based on Part 1 data.
Units
Counts
Participants
OG000
Secondary
Part 2: AUC (0-tau) Following Administration of GSK3368715
Blood samples were planned to be collected for PK analysis of GSK3368715. This analysis was planned but not performed for Part 2 as the study was terminated early during Part 1.
PK Population. Data was not collected as the study was terminated early during Part 1 and hence no participants were enrolled in Part 2.
Posted
Pre-dose, 30 minutes, 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose on Day 15
ID
Title
Description
OG000
Part 2 GSK3368715 Expansion Cohort
Participants with DLBCL were planned to receive recommended Phase II dose (RP2D) based on Part 1 data.
Units
Counts
Participants
OG000
Secondary
Part 2: Ctau Following Administration of GSK3368715
Blood samples were planned to be collected for pharmacokinetic analysis of GSK3368715. This analysis was planned but not performed for Part 2 as the study was terminated early during Part 1.
PK Population. Data was not collected as the study was terminated early during Part 1 and hence no participants were enrolled in Part 2.
Posted
Pre-dose on Day 1 and Day 15
ID
Title
Description
OG000
Part 2 GSK3368715 Expansion Cohort
Participants with DLBCL were planned to receive recommended Phase II dose (RP2D) based on Part 1 data.
Units
Counts
Participants
OG000
Secondary
Part 2: Time Invariance Ratio Following Administration of GSK3368715
Blood samples were planned to be collected for pharmacokinetic analysis of GSK3368715. This analysis was planned but not performed for Part 2 as the study was terminated early during Part 1.
PK Population. Data was not collected as the study was terminated early during Part 1 and hence no participants were enrolled in Part 2.
Posted
Pre-dose, 15, 30 minutes, 1 ,1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 hours post-dose on Day 1; Pre-dose, 30 minutes,1, 2, 3, 4, 6, 8, 12, 24 hours post-dose on Day 15
ID
Title
Description
OG000
Part 2 GSK3368715 Expansion Cohort
Participants with DLBCL were planned to receive recommended Phase II dose (RP2D) based on Part 1 data.
Units
Counts
Participants
OG000
Secondary
Part 2: Accumulation Ratio Following Administration of GSK3368715
Blood samples were planned to be collected for PK analysis of GSK3368715. This analysis was planned but not performed for Part 2 as the study was terminated early during Part 1.
PK Population. Data was not collected as the study was terminated early during Part 1 and hence no participants were enrolled in Part 2.
Posted
Pre-dose, 15, 30 minutes, 1 ,1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 hours post-dose on Day 1; Pre-dose, 30 minutes, 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose on Day 15
ID
Title
Description
OG000
Part 2 GSK3368715 Expansion Cohort
Participants with DLBCL were planned to receive recommended Phase II dose (RP2D) based on Part 1 data.
Units
Counts
Participants
OG000
Time Frame
All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected from the start of the study treatment up to 28 months in Part 1.
Description
All Treated Population included all participants who received at least one dose of GSK3368715. Study was terminated early during Part 1 as the benefit/risk assessment did not favor continuation of the study; therefore, Part 1: Food effect cohorts and Part 2 were not conducted.
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
Part 1 GSK3368715 50mg
Participants with solid relapsed/refractory tumors were administered once daily oral dose of GSK3368715 50 milligrams (mg).
0
3
2
3
3
3
EG001
Part 1 GSK3368715 100mg
Participants with solid relapsed/refractory tumors were administered once daily oral dose of GSK3368715 100mg.
0
16
4
16
15
16
EG002
Part 1 GSK3368715 200mg
Participants with solid relapsed/refractory tumors were administered once daily oral dose of GSK3368715 200mg.
0
12
6
12
9
12
EG003
Part 1:Food Effect Cohort: GSK3368715 Fasted Followed by Fed
Participants with solid relapsed/refractory tumors were planned to receive once daily oral dose of GSK3368715 with a tablet formulation in the fasted state followed by fed state at or near the recommended Phase II dose (RP2D).
0
0
0
0
0
0
EG004
Part 1:Food Effect Cohort: GSK3368715 Fed Followed by Fasted
Participants with solid relapsed/refractory tumors were planned to receive once daily oral dose of GSK3368715 with a tablet formulation in the fed state followed by fasted state at or near the RP2D.
0
0
0
0
0
0
EG005
Part 2 GSK3368715 Expansion Cohort
Participants with DLBCL were planned to receive recommended Phase II dose (RP2D) based on Part 1 data.
0
0
0
0
0
0
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Haemorrhage intracranial
Nervous system disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected16 at risk
EG0021 events1 affected12 at risk
EG0030 events0 affected0 at risk
EG0040 events0 affected0 at risk
EG0050 events0 affected0 at risk
Hemiparesis
Nervous system disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected16 at risk
EG0020 events0 affected12 at risk
EG003
Spinal cord compression
Nervous system disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected16 at risk
EG0021 events1 affected12 at risk
EG003
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected16 at risk
EG0022 events2 affected12 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected16 at risk
EG0020 events0 affected12 at risk
EG003
Hyperbilirubinaemia
Hepatobiliary disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected16 at risk
EG0020 events0 affected12 at risk
EG003
Portal vein thrombosis
Hepatobiliary disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected16 at risk
EG0021 events1 affected12 at risk
EG003
Blood bilirubin increased
Investigations
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected16 at risk
EG0020 events0 affected12 at risk
EG003
Blood creatinine increased
Investigations
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected16 at risk
EG0020 events0 affected12 at risk
EG003
Platelet count decreased
Investigations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected16 at risk
EG0021 events1 affected12 at risk
EG003
Atrial fibrillation
Cardiac disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected16 at risk
EG0021 events1 affected12 at risk
EG003
Vertigo
Ear and labyrinth disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected16 at risk
EG0020 events0 affected12 at risk
EG003
Anal infection
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected16 at risk
EG0020 events0 affected12 at risk
EG003
Pathological fracture
Musculoskeletal and connective tissue disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected16 at risk
EG0021 events1 affected12 at risk
EG003
Mental status changes
Psychiatric disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected16 at risk
EG0020 events0 affected12 at risk
EG003
Aortic thrombosis
Vascular disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected16 at risk
EG0021 events1 affected12 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Nausea
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0002 events2 affected3 at risk
EG0013 events3 affected16 at risk
EG0025 events4 affected12 at risk
EG0030 events0 affected0 at risk
EG0040 events0 affected0 at risk
EG0050 events0 affected0 at risk
Diarrhoea
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected3 at risk
EG0016 events5 affected16 at risk
EG0024 events1 affected12 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0002 events2 affected3 at risk
EG0013 events2 affected16 at risk
EG0025 events3 affected12 at risk
EG003
Abdominal distension
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected3 at risk
EG0011 events1 affected16 at risk
EG0021 events1 affected12 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0002 events1 affected3 at risk
EG0012 events2 affected16 at risk
EG0020 events0 affected12 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected3 at risk
EG0011 events1 affected16 at risk
EG0021 events1 affected12 at risk
EG003
Abdominal discomfort
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected16 at risk
EG0021 events1 affected12 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected16 at risk
EG0020 events0 affected12 at risk
EG003
Anal haemorrhage
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected16 at risk
EG0020 events0 affected12 at risk
EG003
Ascites
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected16 at risk
EG0020 events0 affected12 at risk
EG003
Change of bowel habit
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected16 at risk
EG0020 events0 affected12 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected16 at risk
EG0020 events0 affected12 at risk
EG003
Flatulence
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected16 at risk
EG0020 events0 affected12 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected16 at risk
EG0020 events0 affected12 at risk
EG003
Oesophageal spasm
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected16 at risk
EG0020 events0 affected12 at risk
EG003
Rectal haemorrhage
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected16 at risk
EG0020 events0 affected12 at risk
EG003
Fatigue
General disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected3 at risk
EG0017 events6 affected16 at risk
EG0021 events1 affected12 at risk
EG003
Pyrexia
General disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected3 at risk
EG0015 events5 affected16 at risk
EG0020 events0 affected12 at risk
EG003
Oedema peripheral
General disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected3 at risk
EG0012 events2 affected16 at risk
EG0020 events0 affected12 at risk
EG003
Chest pain
General disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected16 at risk
EG0020 events0 affected12 at risk
EG003
Gait disturbance
General disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected16 at risk
EG0020 events0 affected12 at risk
EG003
Peripheral swelling
General disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected16 at risk
EG0020 events0 affected12 at risk
EG003
Suprapubic pain
General disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected16 at risk
EG0020 events0 affected12 at risk
EG003
Neutrophil count decreased
Investigations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected16 at risk
EG0023 events3 affected12 at risk
EG003
Blood bilirubin increased
Investigations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0013 events3 affected16 at risk
EG0020 events0 affected12 at risk
EG003
Platelet count decreased
Investigations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected16 at risk
EG0022 events2 affected12 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected16 at risk
EG0020 events0 affected12 at risk
EG003
Blood alkaline phosphatase increased
Investigations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected16 at risk
EG0020 events0 affected12 at risk
EG003
Haemoglobin decreased
Investigations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0012 events1 affected16 at risk
EG0020 events0 affected12 at risk
EG003
International normalised ratio increased
Investigations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected16 at risk
EG0021 events1 affected12 at risk
EG003
Lymphocyte count decreased
Investigations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected16 at risk
EG0025 events1 affected12 at risk
EG003
Red blood cell count decreased
Investigations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected16 at risk
EG0021 events1 affected12 at risk
EG003
Weight decreased
Investigations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected16 at risk
EG0020 events0 affected12 at risk
EG003
White blood cell count decreased
Investigations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected16 at risk
EG0021 events1 affected12 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0013 events3 affected16 at risk
EG0020 events0 affected12 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0012 events2 affected16 at risk
EG0020 events0 affected12 at risk
EG003
Bone pain
Musculoskeletal and connective tissue disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected16 at risk
EG0021 events1 affected12 at risk
EG003
Joint swelling
Musculoskeletal and connective tissue disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected16 at risk
EG0020 events0 affected12 at risk
EG003
Muscular weakness
Musculoskeletal and connective tissue disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected16 at risk
EG0020 events0 affected12 at risk
EG003
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected16 at risk
EG0021 events1 affected12 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected16 at risk
EG0020 events0 affected12 at risk
EG003
Neck pain
Musculoskeletal and connective tissue disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected16 at risk
EG0021 events1 affected12 at risk
EG003
Pain in jaw
Musculoskeletal and connective tissue disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected16 at risk
EG0020 events0 affected12 at risk
EG003
Soft tissue swelling
Musculoskeletal and connective tissue disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected16 at risk
EG0020 events0 affected12 at risk
EG003
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0012 events2 affected16 at risk
EG0023 events3 affected12 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected3 at risk
EG0012 events2 affected16 at risk
EG0021 events1 affected12 at risk
EG003
Haemoptysis
Respiratory, thoracic and mediastinal disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected16 at risk
EG0020 events0 affected12 at risk
EG003
Hiccups
Respiratory, thoracic and mediastinal disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected16 at risk
EG0020 events0 affected12 at risk
EG003
Anaemia
Blood and lymphatic system disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected3 at risk
EG00111 events6 affected16 at risk
EG0022 events2 affected12 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected16 at risk
EG0020 events0 affected12 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0012 events2 affected16 at risk
EG0021 events1 affected12 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected16 at risk
EG0021 events1 affected12 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0012 events1 affected16 at risk
EG0020 events0 affected12 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected16 at risk
EG0020 events0 affected12 at risk
EG003
Hyperkalaemia
Metabolism and nutrition disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected16 at risk
EG0020 events0 affected12 at risk
EG003
Hypoalbuminaemia
Metabolism and nutrition disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected16 at risk
EG0020 events0 affected12 at risk
EG003
Hypocalcaemia
Metabolism and nutrition disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected16 at risk
EG0020 events0 affected12 at risk
EG003
Hypophosphataemia
Metabolism and nutrition disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected16 at risk
EG0020 events0 affected12 at risk
EG003
Dizziness
Nervous system disorders
MedDRA 24.0
Systematic Assessment
EG0002 events1 affected3 at risk
EG0012 events1 affected16 at risk
EG0020 events0 affected12 at risk
EG003
Headache
Nervous system disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0013 events2 affected16 at risk
EG0020 events0 affected12 at risk
EG003
Hypoaesthesia
Nervous system disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected3 at risk
EG0011 events1 affected16 at risk
EG0020 events0 affected12 at risk
EG003
Brain oedema
Nervous system disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected16 at risk
EG0020 events0 affected12 at risk
EG003
Hemiparesis
Nervous system disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected16 at risk
EG0021 events1 affected12 at risk
EG003
Neuropathy peripheral
Nervous system disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected16 at risk
EG0021 events1 affected12 at risk
EG003
Peripheral sensory neuropathy
Nervous system disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected16 at risk
EG0020 events0 affected12 at risk
EG003
Vasogenic cerebral oedema
Nervous system disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected16 at risk
EG0020 events0 affected12 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0014 events3 affected16 at risk
EG0020 events0 affected12 at risk
EG003
Device related infection
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected16 at risk
EG0020 events0 affected12 at risk
EG003
Oral herpes
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected16 at risk
EG0020 events0 affected12 at risk
EG003
Pseudomonas infection
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected16 at risk
EG0020 events0 affected12 at risk
EG003
Sepsis
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected16 at risk
EG0020 events0 affected12 at risk
EG003
Vascular device infection
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected16 at risk
EG0020 events0 affected12 at risk
EG003
Haematuria
Renal and urinary disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected16 at risk
EG0021 events1 affected12 at risk
EG003
Dysuria
Renal and urinary disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected16 at risk
EG0020 events0 affected12 at risk
EG003
Proteinuria
Renal and urinary disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected16 at risk
EG0022 events1 affected12 at risk
EG003
Renal failure
Renal and urinary disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected16 at risk
EG0020 events0 affected12 at risk
EG003
Urinary hesitation
Renal and urinary disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected16 at risk
EG0020 events0 affected12 at risk
EG003
Portal vein thrombosis
Hepatobiliary disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected16 at risk
EG0021 events1 affected12 at risk
EG003
Hyperbilirubinaemia
Hepatobiliary disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected16 at risk
EG0020 events0 affected12 at risk
EG003
Jaundice
Hepatobiliary disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected16 at risk
EG0020 events0 affected12 at risk
EG003
Hypotension
Vascular disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0013 events2 affected16 at risk
EG0020 events0 affected12 at risk
EG003
Deep vein thrombosis
Vascular disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected16 at risk
EG0021 events1 affected12 at risk
EG003
Pallor
Vascular disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected16 at risk
EG0020 events0 affected12 at risk
EG003
Dry skin
Skin and subcutaneous tissue disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected16 at risk
EG0020 events0 affected12 at risk
EG003
Hyperhidrosis
Skin and subcutaneous tissue disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected16 at risk
EG0020 events0 affected12 at risk
EG003
Night sweats
Skin and subcutaneous tissue disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected16 at risk
EG0020 events0 affected12 at risk
EG003
Petechiae
Skin and subcutaneous tissue disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected16 at risk
EG0020 events0 affected12 at risk
EG003
Contusion
Injury, poisoning and procedural complications
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected16 at risk
EG0021 events1 affected12 at risk
EG003
Skin abrasion
Injury, poisoning and procedural complications
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected16 at risk
EG0021 events1 affected12 at risk
EG003
Cancer pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected16 at risk
EG0020 events0 affected12 at risk
EG003
Tumour associated fever
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected16 at risk
EG0020 events0 affected12 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected16 at risk
EG0020 events0 affected12 at risk
EG003
Restlessness
Psychiatric disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected16 at risk
EG0020 events0 affected12 at risk
EG003
Ventricular arrhythmia
Cardiac disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected16 at risk
EG0020 events0 affected12 at risk
EG003
Vertigo
Ear and labyrinth disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected16 at risk
EG0020 events0 affected12 at risk
EG003
Lacrimation increased
Eye disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected16 at risk
EG0020 events0 affected12 at risk
EG003
Hypersensitivity
Immune system disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected16 at risk
EG0021 events1 affected12 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Part 1:Food Effect Cohort: GSK3368715 Fasted Followed by Fed
Participants with solid relapsed/refractory tumors were planned to receive once daily oral dose of GSK3368715 with a tablet formulation in the fasted state followed by fed state at or near the recommended Phase II dose (RP2D).
OG004
Part 1:Food Effect Cohort: GSK3368715 Fed Followed by Fasted
Participants with solid relapsed/refractory tumors were planned to receive once daily oral dose of GSK3368715 with a tablet formulation in the fed state followed by fasted state at or near the RP2D.
Units
Counts
Participants
OG0003
OG00116
OG00212
OG0030
OG0040
Title
Denominators
Categories
Any Non-SAE
Title
Measurements
OG0003
OG00115
OG0029
Any SAE
Title
Measurements
OG0002
OG0014
OG0026
OG002
Part 1 GSK3368715 200mg
Participants with solid relapsed/refractory tumors were administered once daily oral dose of GSK3368715 200mg.
OG003
Part 1:Food Effect Cohort: GSK3368715 Fasted Followed by Fed
Participants with solid relapsed/refractory tumors were planned to receive once daily oral dose of GSK3368715 with a tablet formulation in the fasted state followed by fed state at or near the recommended Phase II dose (RP2D).
OG004
Part 1:Food Effect Cohort: GSK3368715 Fed Followed by Fasted
Participants with solid relapsed/refractory tumors were planned to receive once daily oral dose of GSK3368715 with a tablet formulation in the fed state followed by fasted state at or near the RP2D.
Units
Counts
Participants
OG0003
OG00116
OG00212
OG0030
OG0040
Title
Denominators
Categories
Grade 1
Title
Measurements
OG0001
OG0010
OG0022
Grade 2
Title
Measurements
OG0001
OG0019
OG0021
Grade 3
Title
Measurements
OG0001
OG0015
OG0025
Grade 4
Title
Measurements
OG0000
OG0011
OG0022
Grade 5
Title
Measurements
OG0000
OG0010
OG0022
0
Participants with solid relapsed/refractory tumors were administered once daily oral dose of GSK3368715 200mg.
OG003
Part 1:Food Effect Cohort: GSK3368715 Fasted Followed by Fed
Participants with solid relapsed/refractory tumors were planned to receive once daily oral dose of GSK3368715 with a tablet formulation in the fasted state followed by fed state at or near the recommended Phase II dose (RP2D).
OG004
Part 1:Food Effect Cohort: GSK3368715 Fed Followed by Fasted
Participants with solid relapsed/refractory tumors were planned to receive once daily oral dose of GSK3368715 with a tablet formulation in the fed state followed by fasted state at or near the RP2D.
Units
Counts
Participants
OG0003
OG00116
OG00212
OG0030
OG0040
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0020
Participants with solid relapsed/refractory tumors were administered once daily oral dose of GSK3368715 200mg.
Units
Counts
Participants
OG0003
OG00116
OG00212
Title
Denominators
Categories
GSK3368715 Day 1,n=3,16,12
ParticipantsOG0003
ParticipantsOG00116
ParticipantsOG00212
Title
Measurements
OG000107.166± 48.81
OG001197.420± 112.05
OG002336.771± 72.57
GSK3368715 Day 15,n=3,14,9
ParticipantsOG0003
ParticipantsOG00114
ParticipantsOG0029
Title
Measurements
OG000
Units
Counts
Participants
OG0003
OG00116
OG00212
Title
Denominators
Categories
GSK3368715 Day 1,n=3,16,12
ParticipantsOG0003
ParticipantsOG00116
ParticipantsOG00212
Title
Measurements
OG0000.5326± 180.404
OG0010.6821± 94.273
OG0021.1594± 86.483
GSK3368715 Day 15,n=3,14,9
ParticipantsOG0003
ParticipantsOG00114
ParticipantsOG0029
Title
Measurements
OG000
Participants with solid relapsed/refractory tumors were administered once daily oral dose of GSK3368715 200mg.
Units
Counts
Participants
OG0003
OG00116
OG00212
Title
Denominators
Categories
GSK3368715 Day 1,n=3,16,12
ParticipantsOG0003
ParticipantsOG00116
ParticipantsOG00212
Title
Measurements
OG000283.4828± 32.756
OG001483.1405± 107.980
OG0021400.0804± 64.718
GSK3368715 Day 15,n=3,14,9
ParticipantsOG0003
ParticipantsOG00114
ParticipantsOG0029
Title
Measurements
OG000
Participants with solid relapsed/refractory tumors were administered once daily oral dose of GSK3368715 200mg.
Units
Counts
Participants
OG0000
OG0012
OG0024
Title
Denominators
Categories
Title
Measurements
OG0011217.5147± 27.619
OG0021674.8304± 50.515
Units
Counts
Participants
OG0002
OG00114
OG0029
Title
Denominators
Categories
Title
Measurements
OG000581.9071± 101.434
OG0011573.8450± 64.183
OG0024861.3917± 45.288
Units
Counts
Participants
OG0003
OG00116
OG00211
Title
Denominators
Categories
GSK3368715 Day 1,n=3,16,11
ParticipantsOG0003
ParticipantsOG00116
ParticipantsOG00211
Title
Measurements
OG0005.150± NAData could not be calculated as these were derivate values which were below the lower limit of quantification.
OG0017.880± 18.46
OG00212.642± 73.85
GSK3368715 Day 15,n=3,14,10
ParticipantsOG0003
ParticipantsOG00114
ParticipantsOG00210
Title
Measurements
OG000
Part 1 GSK3368715 200mg
Participants with solid relapsed/refractory tumors were administered once daily oral dose of GSK3368715 200mg.
Units
Counts
Participants
OG0000
OG0012
OG0024
Title
Denominators
Categories
Title
Measurements
OG0011.6007± 15.614
OG0022.9492± 43.451
Part 1 GSK3368715 200mg
Participants with solid relapsed/refractory tumors were administered once daily oral dose of GSK3368715 200mg.