An Open-Label, Dose-Escalation Study of INCB054329 in Pat... | NCT02431260 | Trialant
NCT02431260
Sponsor
Incyte Corporation
Status
Terminated
Last Update Posted
Jun 14, 2019Actual
Enrollment
69Actual
Phase
Phase 1Phase 2
Conditions
Solid Tumors and Hematologic Malignancy
Interventions
INCB054329 Monotherapy
Countries
United States
Protocol Section
Identification Module
NCT ID
NCT02431260
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
INCB 54329-101
Secondary IDs
Not provided
Brief Title
An Open-Label, Dose-Escalation Study of INCB054329 in Patients With Advanced Malignancies
Official Title
A Phase 1/2, Open-Label, Dose-Escalation, Safety and Tolerability Study of INCB054329 in Subjects With Advanced Malignancies
Acronym
Not provided
Organization
Incyte CorporationINDUSTRY
Status Module
Record Verification Date
May 2019
Overall Recruitment Status or Expanded Access Status
Terminated
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
As of 31 JAN 2018, the study was terminated by the sponsor due to PK variability.
Expanded Access Info
YesNCT03896815No longer available
Start Date
Apr 14, 2015Actual
Primary Completion Date
Jan 31, 2018Actual
Completion Date
Jan 31, 2018Actual
First Submitted Date
Apr 27, 2015
First Submission Date that Met QC Criteria
Apr 29, 2015
First Posted Date
Apr 30, 2015Estimated
Results Waived
Not provided
Results First Submitted Date
Jan 29, 2019
Results First Submitted that Met QC Criteria
May 17, 2019
Results First Posted Date
Jun 14, 2019Actual
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
May 17, 2019
Last Update Posted Date
Jun 14, 2019Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Incyte CorporationINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
Not provided
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
This was a study of INCB054329 given to patients with advanced malignancies that were conducted in three treatment groups. Each treatment group had a dose escalation (Part 1) and a dose expansion (Part 3), two of the treatment groups also had an intra-patient dose titration (Part 2).
Detailed Description
Not provided
Conditions Module
Conditions
Solid Tumors and Hematologic Malignancy
Keywords
solid tumor
lymphoma
BET bromodomain inhibitor
BRD
Diffuse large B-cell lymphoma (DLBCL)
Burkitt's lymphoma
c-MYC
colorectal cancer
Non-small cell lung cancer
Pancreatic adenocarcinoma
castration-resistant prostate cancer
breast cancer
NUT midline carcinoma
leukemia
acute myeloid leukemia (AML)
myelodysplastic syndrome (MDS)
myeloproliferative neoplasms
myelofibrosis (MF)
multiple myeloma (MM)
MDS/MPN
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 1Phase 2
Interventional Study Design
Allocation
Not provided
Intervention Model
Biospecimen
No data available
No data is available for this block.
Enrollment
69Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
INCB054329 Monotherapy
Experimental
Drug: INCB054329 Monotherapy
Interventions
Name
Type
Description
Arm Group Labels
Other Names
INCB054329 Monotherapy
Drug
Initial cohort dose of INCB054329 monotherapy at the protocol-specified starting dose in the treatment group A (TGA), with subsequent cohort escalations in the three treatment groups (TGA, TGB, and TGC) based on protocol-specific criteria
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Number of Participants With a Treatment-emergent Adverse Event (TEAE)
TEAE is defined as an adverse event reported for the first time or worsening of a pre-existing event after the first dose of study treatment.
up to 30 days
Secondary Outcomes
Measure
Description
Time Frame
Maximum Plasma Concentration (Cmax) Analysis of INCB054329
Cmax is defined as the maximum observed serum concentration measured at steady state (Day 15).
Study drug was administered with 240 mL of water. Summary of Steady-State, Day 15, was evaluated by dosing regimen.
Summary of steady-state PK parameters by dosing regimen at Day 15
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Key Inclusion Criteria:
Confirmed diagnosis of advanced malignancy:
Treatment Group A (TGA): Part 1 and Part 2: Any advanced solid tumor or lymphoma; Part 3: Histologically confirmed disease in specific solid tumors and lymphomas
Treatment Group B (TGB): Acute Leukemia (Part 3 - acute myeloid leukemia [AML] only), myelodysplastic syndrome (MDS), myelodysplastic /myeloproliferative neoplasms (MDS/MPN) and myelofibrosis (MF)
Treatment Group C (TGC): Multiple myeloma
Progressed following at least 1 line of prior therapy and there is no further approved therapy available that has been demonstrated to prolong survival (including subjects who are intolerant to the approved therapy)
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 in Parts 1 and 2 dose escalation and titration, and 0, 1, 2 in Part 3 dose expansion
Key Exclusion Criteria:
Inadequate hematopoietic, liver, endocrine or renal function
Receipt of anticancer medications or investigational drugs within the following interval before the first administration of study drug:
< 6 weeks for mitomycin-C or nitrosoureas
< 5 half-lives or 14 days, whichever is longer, for any investigational agent (for any indication)
< 28 days for any antibodies or biological therapies
< 5 half-lives for all other anticancer medications, or sponsor approval
Prior radiotherapy within 2 weeks prior to first dose of study drug
Untreated brain or central nervous system (CNS) metastases
Type 1 diabetes or uncontrolled Type 2 diabetes
Any sign of clinically significant bleeding
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
Not provided
Standard Ages
AdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Fred Zheng, M.D.
Incyte Corporation
Study Director
Locations
Facility
Status
City
State
ZIP
Country
Contacts
Cedars-Sinai Medical Center
Los Angeles
California
90048
United States
University of California, San Francisco, Medical Center at Mount Zion
Falchook G, Rosen S, LoRusso P, Watts J, Gupta S, Coombs CC, Talpaz M, Kurzrock R, Mita M, Cassaday R, Harb W, Peguero J, Smith DC, Piha-Paul SA, Szmulewitz R, Noel MS, Yeleswaram S, Liu P, Switzky J, Zhou G, Zheng F, Mehta A. Development of 2 Bromodomain and Extraterminal Inhibitors With Distinct Pharmacokinetic and Pharmacodynamic Profiles for the Treatment of Advanced Malignancies. Clin Cancer Res. 2020 Mar 15;26(6):1247-1257. doi: 10.1158/1078-0432.CCR-18-4071. Epub 2019 Sep 16.
See Also Links
Not provided
Available IPD Information
Not provided
IPD Sharing Statement Module
Plan to Share IPD
No
Description
Not provided
Types
Not provided
Time Frame
Not provided
Access Criteria
Not provided
URL
Not provided
Results Section
Participant Flow Module
Pre-assignment Details
Not provided
Recruitment Details
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Part 1 / Treatment Group A: 15 MG QD INCB054329
Part 1 / treatment group A (TGA): Initial cohort dose of INCB054329 monotherapy at the protocol-specified starting dose in the TGA. Treatment Group A included any advanced solid tumor or lymphoma.
FG001
Part 1 / Treatment Group A: 22.5 MG QD INCB054329
Periods
Title
Milestones
Reasons Not Completed
Overall Study
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 8, 2016
Jan 29, 2019
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.
Sequential Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
None (Open Label)
Masking Description
Not provided
Who Masked
Not provided
INCB054329 Monotherapy
Time to Maximum Plasma Concentration (Tmax) Analysis of INCB054329
Tmax is the time to maximum (peak) drug serum concentration. Study drug was administered with 240 mL of water. Summary of Steady-State, Day 15, was evaluated by dosing regimen.
Summary of steady-state PK parameters by dosing regimen at Day 15
Minimum Observed Plasma Concentration Over the Dose Interval (Cmin) Analysis of INCB054329
Minimum observed plasma concentration measured at steady state (Day 15). Study drug was administered with 240 mL of water. Summary of Steady-State, Day 15, was evaluated by dosing regimen.
Summary of steady-state PK parameters by dosing regimen at Day 15
AUC0-t Analysis of INCB054329
AUC0-t is the area under the plasma or serum concentration-time curve from time = 0 to the last measurable concentration at time = t measured at steady state (Day 15).
Study drug was administered with 240 mL of water.
Summary of steady-state PK parameters by dosing regimen at Day 15
Cl/F Analysis of INCB054329
Cl/F is the apparent oral dose clearance measured at steady state (Day 15). Study drug was administered with 240 mL of water.
Summary of steady-state PK parameters by dosing regimen at Day 15
Pharmacodynamics (PD) Analysis - Total c-Myc % Inhibition Versus INCB054329
The half maximal inhibitory concentration (IC50) of INCB054329 was measured. The maximal inhibition of total c-Myc was correlated to the level of drug exposure and demonstrated a high degree of interparticipant variability, parallel to the PK data.
The measure was performed as a value across all cohorts. The entire dose escalation data set was used to create the relationship curve. Analysis of individual cohorts contained too few subjects and was biased toward one region of the curve so that the relationship was poorly defined.
Individual data points from all subjects were subjected to a nonlinear least squares regression analysis with no weighting, resulting in a sigmoidal dose response curve defining the relationship. The numerical value given is the projected INCB0054329 concentration in nM that produced 50% inhibition of c-myc expression.
Day 15 in all cohorts
Objective Response Rate (ORR)
Defined as the percentage of subjects having complete response (CR) or partial response (PR). The best overall response was defined as the best response recorded before and including the first event of Progressive disease (PD).
Baseline through end of study, up to 6 months
Duration of Response (DOR)
Defined as the time from earliest date of disease response until earliest date of disease progression or death.
Baseline through end of study, up to 6 months
Progression Free Survival (PFS)
PFS is the time from start of study treatment to first documentation of progression, or to death due to any cause, whichever comes first
Baseline through end of study, up to 6 months
Overall Survival (OS)
OS is defined as the time from the date of randomization to the date of the participant's death.
Baseline through end of study, up to 6 months for participants in Part 2
San Francisco
California
94115
United States
Sarah Cannon Research Institute Research Center
Denver
Colorado
80218
United States
Northwestern Memorial Hospital
Chicago
Illinois
60611
United States
The University of Chicago Medical Center
Chicago
Illinois
60637
United States
Horizon Oncology Center
Lafayette
Indiana
47905
United States
John Hopkins
Baltimore
Maryland
21287-0013
United States
University of Michigan Comprehensive Cancer Center
Ann Arbor
Michigan
48109
United States
Washington University School of Medicine in St. Louis
St Louis
Missouri
63110
United States
Vanderbilt University Medical Center
Nashville
Tennessee
37232-0021
United States
The University of Texas MD Anderson Cancer Center
Houston
Texas
77030
United States
Seattle Cancer Care Alliance
Seattle
Washington
98109
United States
Part 1 / treatment group A (TGA): Initial cohort dose of INCB054329 monotherapy at the protocol-specified starting dose in the TGA. Treatment Group A included any advanced solid tumor or lymphoma.
FG002
Part 1 / Treatment Group A: 15 MG BID INCB054329
Part 1 / treatment group A (TGA): Initial cohort dose of INCB054329 monotherapy at the protocol-specified starting dose in the TGA. Treatment Group A included any advanced solid tumor or lymphoma.
FG003
Part 1 / Treatment Group A: 30 MG QD INCB054329
Part 1 / treatment group A (TGA): Initial cohort dose of INCB054329 monotherapy at the protocol-specified starting dose in the TGA. Treatment Group A included any advanced solid tumor or lymphoma.
FG004
Part 1 / Treatment Group A: 22.5 MG BID INCB054329
Part 1 / treatment group A (TGA): Initial cohort dose of INCB054329 monotherapy at the protocol-specified starting dose in the TGA. Treatment Group A included any advanced solid tumor or lymphoma.
FG005
Part 1 / Treatment Group A: 22.5 MG BID 5/2 INCB054329
Part 1 / treatment group A (TGA): Initial cohort dose of INCB054329 monotherapy at the protocol-specified starting dose in the TGA. 5/2=5 days on/2 days off.
Treatment Group A included any advanced solid tumor or lymphoma.
FG006
Part 1 / Treatment Group A: 22.5 MG BID 4/3 INCB054329
Part 1 / treatment group A (TGA): Initial cohort dose of INCB054329 monotherapy at the protocol-specified starting dose in the TGA. 4/3=4 days on/3 days off. Treatment Group A included any advanced solid tumor or lymphoma.
FG007
Part 1 / Treatment Group A: 22.5 MG BID 7/7 INCB054329
Part 1 / treatment group A (TGA): Initial cohort dose of INCB054329 monotherapy at the protocol-specified starting dose in the TGA. 7/7=7 days on/7 days off. Treatment Group A included any advanced solid tumor or lymphoma.
FG008
Part 1 / Treatment Group A: 20 MG BID INCB054329
Part 1 / treatment group A (TGA): Initial cohort dose of INCB054329 monotherapy at the protocol-specified starting dose in the TGA. Treatment Group A included any advanced solid tumor or lymphoma.
FG009
Part 1 / Treatment Group A: 25 MG BID 5/2 INCB054329
Part 1 / treatment group A (TGA): Initial cohort dose of INCB054329 monotherapy at the protocol-specified starting dose in the TGA. 5/2=5 days on/2 days off. Treatment Group A included any advanced solid tumor or lymphoma.
FG010
Part 1 / Treatment Group A: 25 MG BID 7/7 INCB054329
Part 1 / treatment group A (TGA): Initial cohort dose of INCB054329 monotherapy at the protocol-specified starting dose in the TGA. 7/7=7 days on/7 days off. Treatment Group A included any advanced solid tumor or lymphoma.
FG011
Part 1 / Treatment Group B: 20 MG BID INCB054329
Part 1 / treatment group B (TGB): Initial cohort dose of INCB054329 monotherapy at the protocol-specified cohort escalation treatment group B (TGB), based on protocol-specific criteria. Treatment Group B included acute leukemia, myelodysplastic syndrome, myelodysplastic/myeloproliferative neoplasms, or myelofibrosis.
FG012
Part 2 / Treatment Group A: 20 MG BID INCB054329
Part 2 / treatment group A (TGA): dose titration was to determine the feasibility of intraparticipant dose titration using Protocol-defined criteria. Treatment Group A included any advanced solid tumor or lymphoma.
FG013
Part 2 / Treatment Group C: 20 mg BID INCB054329
Part 2 / treatment group C (TGC): dose titration was to determine the feasibility of intraparticipant dose titration using Protocol-defined criteria. Treatment Group C included multiple myeloma.
FG0004 subjects
FG0015 subjects
FG0026 subjects
FG0035 subjects
FG0043 subjects
FG0054 subjects
FG0064 subjects
FG0073 subjects
FG0088 subjects
FG0098 subjects
FG0104 subjects
FG0114 subjects
FG01210 subjects
FG0131 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
NOT COMPLETED
FG0004 subjects
FG0015 subjects
FG0026 subjects
FG0035 subjects
FG0043 subjects
FG0054 subjects
FG0064 subjects
FG0073 subjects
FG0088 subjects
FG0098 subjects
FG0104 subjects
FG0114 subjects
FG01210 subjects
FG0131 subjects
Type
Comment
Reasons
Subject Decision
FG0000 subjects
FG0011 subjects
FG0021 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0081 subjects
FG0091 subjects
FG0100 subjects
FG0111 subjects
FG0120 subjects
FG0130 subjects
Death
FG0004 subjects
FG0014 subjects
FG0023 subjects
FG0034 subjects
FG004
Lost to Follow-up
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Study Terminated by the Sponsor
FG0000 subjects
FG0010 subjects
FG0022 subjects
FG0031 subjects
FG004
Physician Decision
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Other Unspecified
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
The safety population included all enrolled participants who received at least 1 dose of INCB054329.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Part 1 / Treatment Group A: 15 MG QD INCB054329
Part 1 / treatment group A (TGA): Initial cohort dose of INCB054329 monotherapy at the protocol-specified starting dose in the TGA. Treatment Group A included any advanced solid tumor or lymphoma.
BG001
Part 1 / Treatment Group A: 22.5 MG QD INCB054329
Part 1 / treatment group A (TGA): Initial cohort dose of INCB054329 monotherapy at the protocol-specified starting dose in the TGA. Treatment Group A included any advanced solid tumor or lymphoma.
BG002
Part 1 / Treatment Group A: 15 MG BID INCB054329
Part 1 / treatment group A (TGA): Initial cohort dose of INCB054329 monotherapy at the protocol-specified starting dose in the TGA. Treatment Group A included any advanced solid tumor or lymphoma.
BG003
Part 1 / Treatment Group A: 30 MG QD INCB054329
Part 1 / treatment group A (TGA): Initial cohort dose of INCB054329 monotherapy at the protocol-specified starting dose in the TGA. Treatment Group A included any advanced solid tumor or lymphoma.
BG004
Part 1 / Treatment Group A: 22.5 MG BID INCB054329
Part 1 / treatment group A (TGA): Initial cohort dose of INCB054329 monotherapy at the protocol-specified starting dose in the TGA. Treatment Group A included any advanced solid tumor or lymphoma.
BG005
Part 1 / Treatment Group A: 22.5 MG BID 5/2 INCB054329
Part 1 / treatment group A (TGA): Initial cohort dose of INCB054329 monotherapy at the protocol-specified starting dose in the TGA. 5/2=5 days on/2 days off.
Treatment Group A included any advanced solid tumor or lymphoma.
BG006
Part 1 / Treatment Group A: 22.5 MG BID 4/3 INCB054329
Part 1 / treatment group A (TGA): Initial cohort dose of INCB054329 monotherapy at the protocol-specified starting dose in the TGA. 4/3=4 days on/3 days off. Treatment Group A included any advanced solid tumor or lymphoma.
BG007
Part 1 / Treatment Group A: 22.5 MG BID 7/7 INCB054329
Part 1 / treatment group A (TGA): Initial cohort dose of INCB054329 monotherapy at the protocol-specified starting dose in the TGA. 7/7=7 days on/7 days off. Treatment Group A included any advanced solid tumor or lymphoma.
BG008
Part 1 / Treatment Group A: 20 MG BID INCB054329
Part 1 / treatment group A (TGA): Initial cohort dose of INCB054329 monotherapy at the protocol-specified starting dose in the TGA. Treatment Group A included any advanced solid tumor or lymphoma.
BG009
Part 1 / Treatment Group A: 25 MG BID 5/2 INCB054329
Part 1 / treatment group A (TGA): Initial cohort dose of INCB054329 monotherapy at the protocol-specified starting dose in the TGA. 5/2=5 days on/2 days off. Treatment Group A included any advanced solid tumor or lymphoma.
BG010
Part 1 / Treatment Group A: 25 MG BID 7/7 INCB054329
Part 1 / treatment group A (TGA): Initial cohort dose of INCB054329 monotherapy at the protocol-specified starting dose in the TGA. 7/7=7 days on/7 days off. Treatment Group A included any advanced solid tumor or lymphoma.
BG011
Part 1 / Treatment Group B: 20 MG BID INCB054329
Part 1 / treatment group B (TGB): Initial cohort dose of INCB054329 monotherapy at the protocol-specified cohort escalation treatment group B (TGB), based on protocol-specific criteria. Treatment Group B included acute leukemia, myelodysplastic syndrome, myelodysplastic/myeloproliferative neoplasms, or myelofibrosis.
BG012
Part 2 / Treatment Group A: 20 MG BID INCB054329
Part 2 / treatment group A (TGA): dose titration was to determine the feasibility of intraparticipant dose titration using Protocol-defined criteria. Treatment Group A included any advanced solid tumor or lymphoma.
BG013
Part 2 / Treatment Group C: 20 mg BID INCB054329
Part 2 / treatment group C (TGC): dose titration was to determine the feasibility of intraparticipant dose titration using Protocol-defined criteria. Treatment Group C included multiple myeloma.
BG014
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG0004
BG0015
BG0026
BG0035
BG0043
BG0054
BG0064
BG0073
BG0088
BG0098
BG0104
BG0114
BG01210
BG0131
BG01469
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00062.3± 4.03
BG00154.8± 13.39
BG00257.7± 8.50
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0002
BG0012
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0000
BG0010
BG002
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0000
BG0010
BG002
Height
Mean
Standard Deviation
cm
Title
Denominators
Categories
Title
Measurements
BG000167.3± 8.02
BG001172.7± 11.47
BG002
Weight
Mean
Standard Deviation
kg
Title
Denominators
Categories
Title
Measurements
BG00070.0± 9.19
BG00166.2± 11.14
BG002
Body mass index (BMI)
BMI is a measure of body fat based on height and weight that applies to adult men and women.
Mean
Standard Deviation
kg/m^2
Title
Denominators
Categories
Title
Measurements
BG00025.2± 4.34
BG00122.3± 3.68
Eastern Cooperative Oncology Group (ECOG)
ECOG performance status measured on 6 point scale to assess participant's performance status. 0=Fully active, able to carry on all pre-disease activities without restriction; 1=Restricted in physically strenuous activity, ambulatory and able to carry out light or sedentary work; 2=Ambulatory (greater than [>]50% of waking hours), capable of all self care, unable to carry out any work activities
Count of Participants
Participants
Title
Denominators
Categories
ECOG - 0
Title
Measurements
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
Number of Participants With a Treatment-emergent Adverse Event (TEAE)
TEAE is defined as an adverse event reported for the first time or worsening of a pre-existing event after the first dose of study treatment.
The safety population included all enrolled participants who received at least 1 dose of INCB054329.
Posted
Count of Participants
Participants
up to 30 days
ID
Title
Description
OG000
Part 1 / Treatment Group A: 15 MG QD INCB054329
Part 1 / treatment group A (TGA): Initial cohort dose of INCB054329 monotherapy at the protocol-specified starting dose in the TGA. Treatment Group A included any advanced solid tumor or lymphoma.
OG001
Part 1 / Treatment Group A: 22.5 MG QD INCB054329
Part 1 / treatment group A (TGA): Initial cohort dose of INCB054329 monotherapy at the protocol-specified starting dose in the TGA. Treatment Group A included any advanced solid tumor or lymphoma.
OG002
Part 1 / Treatment Group A: 15 MG BID INCB054329
Part 1 / treatment group A (TGA): Initial cohort dose of INCB054329 monotherapy at the protocol-specified starting dose in the TGA. Treatment Group A included any advanced solid tumor or lymphoma.
OG003
Part 1 / Treatment Group A: 30 MG QD INCB054329
Part 1 / treatment group A (TGA): Initial cohort dose of INCB054329 monotherapy at the protocol-specified starting dose in the TGA. Treatment Group A included any advanced solid tumor or lymphoma.
OG004
Part 1 / Treatment Group A: 22.5 MG BID INCB054329
Part 1 / treatment group A (TGA): Initial cohort dose of INCB054329 monotherapy at the protocol-specified starting dose in the TGA. Treatment Group A included any advanced solid tumor or lymphoma.
OG005
Part 1 / Treatment Group A: 22.5 MG BID 5/2 INCB054329
Part 1 / treatment group A (TGA): Initial cohort dose of INCB054329 monotherapy at the protocol-specified starting dose in the TGA. 5/2=5 days on/2 days off.
Treatment Group A included any advanced solid tumor or lymphoma.
OG006
Part 1 / Treatment Group A: 22.5 MG BID 4/3 INCB054329
Part 1 / treatment group A (TGA): Initial cohort dose of INCB054329 monotherapy at the protocol-specified starting dose in the TGA. 4/3=4 days on/3 days off. Treatment Group A included any advanced solid tumor or lymphoma.
OG007
Part 1 / Treatment Group A: 22.5 MG BID 7/7 INCB054329
Part 1 / treatment group A (TGA): Initial cohort dose of INCB054329 monotherapy at the protocol-specified starting dose in the TGA. 7/7=7 days on/7 days off. Treatment Group A included any advanced solid tumor or lymphoma.
OG008
Part 1 / Treatment Group A: 20 MG BID INCB054329
Part 1 / treatment group A (TGA): Initial cohort dose of INCB054329 monotherapy at the protocol-specified starting dose in the TGA. Treatment Group A included any advanced solid tumor or lymphoma.
OG009
Part 1 / Treatment Group A: 25 MG BID 5/2 INCB054329
Part 1 / treatment group A (TGA): Initial cohort dose of INCB054329 monotherapy at the protocol-specified starting dose in the TGA. 5/2=5 days on/2 days off. Treatment Group A included any advanced solid tumor or lymphoma.
OG010
Part 1 / Treatment Group A: 25 MG BID 7/7 INCB054329
Part 1 / treatment group A (TGA): Initial cohort dose of INCB054329 monotherapy at the protocol-specified starting dose in the TGA. 7/7=7 days on/7 days off. Treatment Group A included any advanced solid tumor or lymphoma.
OG011
Part 1 / Treatment Group B: 20 MG BID INCB054329
Part 1 / treatment group B (TGB): Initial cohort dose of INCB054329 monotherapy at the protocol-specified cohort escalation treatment group B (TGB), based on protocol-specific criteria. Treatment Group B included acute leukemia, myelodysplastic syndrome, myelodysplastic/myeloproliferative neoplasms, or myelofibrosis.
OG012
Part 2 / Treatment Group A: 20 MG BID INCB054329
Part 2 / treatment group A (TGA): dose titration was to determine the feasibility of intraparticipant dose titration using Protocol-defined criteria. Treatment Group A included any advanced solid tumor or lymphoma.
OG013
Part 2 / Treatment Group C: 20 mg BID INCB054329
Part 2 / treatment group C (TGC): dose titration was to determine the feasibility of intraparticipant dose titration using Protocol-defined criteria. Treatment Group C included multiple myeloma.
Units
Counts
Participants
OG0004
OG0015
OG0026
OG003
Title
Denominators
Categories
Title
Measurements
OG0004
OG0015
OG0026
OG003
Secondary
Maximum Plasma Concentration (Cmax) Analysis of INCB054329
Cmax is defined as the maximum observed serum concentration measured at steady state (Day 15).
Study drug was administered with 240 mL of water. Summary of Steady-State, Day 15, was evaluated by dosing regimen.
All enrolled patients who received at least 1 dose of study medication and provided at least 1 plasma sample were included.
Posted
Mean
Standard Deviation
nM
Summary of steady-state PK parameters by dosing regimen at Day 15
ID
Title
Description
OG000
INCB054329 Monotherapy - 15 mg QD
INCB054329 Monotherapy
OG001
INCB054329 Monotherapy - 15 mg BID
INCB054329 Monotherapy
OG002
INCB054329 Monotherapy - 22.5 mg QD
INCB054329 Monotherapy
OG003
INCB054329 Monotherapy - 30 mg QD
INCB054329 Monotherapy
OG004
Secondary
Time to Maximum Plasma Concentration (Tmax) Analysis of INCB054329
Tmax is the time to maximum (peak) drug serum concentration. Study drug was administered with 240 mL of water. Summary of Steady-State, Day 15, was evaluated by dosing regimen.
All enrolled patients who received at least 1 dose of study medication and provided at least 1 plasma sample were included.
Posted
Median
Full Range
hour
Summary of steady-state PK parameters by dosing regimen at Day 15
ID
Title
Description
OG000
INCB054329 Monotherapy - 15 mg QD
INCB054329 Monotherapy
OG001
INCB054329 Monotherapy - 15 mg BID
INCB054329 Monotherapy
OG002
INCB054329 Monotherapy - 22.5 mg QD
INCB054329 Monotherapy
OG003
INCB054329 Monotherapy - 30 mg QD
INCB054329 Monotherapy
OG004
INCB054329 Monotherapy - 20 mg BID
Secondary
Minimum Observed Plasma Concentration Over the Dose Interval (Cmin) Analysis of INCB054329
Minimum observed plasma concentration measured at steady state (Day 15). Study drug was administered with 240 mL of water. Summary of Steady-State, Day 15, was evaluated by dosing regimen.
All enrolled patients who received at least 1 dose of study medication and provided at least 1 plasma sample were included.
Posted
Mean
Standard Deviation
nM
Summary of steady-state PK parameters by dosing regimen at Day 15
ID
Title
Description
OG000
INCB054329 Monotherapy - 15 mg QD
INCB054329 Monotherapy
OG001
INCB054329 Monotherapy - 15 mg BID
INCB054329 Monotherapy
OG002
INCB054329 Monotherapy - 22.5 mg QD
INCB054329 Monotherapy
OG003
INCB054329 Monotherapy - 30 mg QD
INCB054329 Monotherapy
OG004
Secondary
AUC0-t Analysis of INCB054329
AUC0-t is the area under the plasma or serum concentration-time curve from time = 0 to the last measurable concentration at time = t measured at steady state (Day 15).
Study drug was administered with 240 mL of water.
All enrolled patients who received at least 1 dose of study medication and provided at least 1 plasma sample were included.
Posted
Mean
Standard Deviation
nM*h
Summary of steady-state PK parameters by dosing regimen at Day 15
ID
Title
Description
OG000
INCB054329 Monotherapy - 15 mg QD
INCB054329 Monotherapy
OG001
INCB054329 Monotherapy - 15 mg BID
INCB054329 Monotherapy
OG002
INCB054329 Monotherapy - 22.5 mg QD
INCB054329 Monotherapy
OG003
INCB054329 Monotherapy - 30 mg QD
INCB054329 Monotherapy
OG004
INCB054329 Monotherapy - 20 mg BID
Secondary
Cl/F Analysis of INCB054329
Cl/F is the apparent oral dose clearance measured at steady state (Day 15). Study drug was administered with 240 mL of water.
All enrolled patients who received at least 1 dose of study medication and provided at least 1 plasma sample were included.
Posted
Mean
Standard Deviation
L/h
Summary of steady-state PK parameters by dosing regimen at Day 15
ID
Title
Description
OG000
INCB054329 Monotherapy - 15 mg QD
INCB054329 Monotherapy
OG001
INCB054329 Monotherapy - 15 mg BID
INCB054329 Monotherapy
OG002
INCB054329 Monotherapy - 22.5 mg BID
INCB054329 Monotherapy
OG003
INCB054329 Monotherapy - 30 mg QD
INCB054329 Monotherapy
OG004
INCB054329 Monotherapy - 20 mg BID
Secondary
Pharmacodynamics (PD) Analysis - Total c-Myc % Inhibition Versus INCB054329
The half maximal inhibitory concentration (IC50) of INCB054329 was measured. The maximal inhibition of total c-Myc was correlated to the level of drug exposure and demonstrated a high degree of interparticipant variability, parallel to the PK data.
The measure was performed as a value across all cohorts. The entire dose escalation data set was used to create the relationship curve. Analysis of individual cohorts contained too few subjects and was biased toward one region of the curve so that the relationship was poorly defined.
Individual data points from all subjects were subjected to a nonlinear least squares regression analysis with no weighting, resulting in a sigmoidal dose response curve defining the relationship. The numerical value given is the projected INCB0054329 concentration in nM that produced 50% inhibition of c-myc expression.
Individual data points from all subjects were subjected to a nonlinear least squares regression analysis with no weighting, resulting in a sigmoidal dose response curve defining the relationship. The numerical value given is the projected INCB0054329 concentration in nM that produced 50% inhibition of c-myc expression.
Posted
Number
nM
Day 15 in all cohorts
ID
Title
Description
OG000
INCB054329 Monotherapy
INCB054329 Monotherapy: Initial cohort dose of INCB054329 monotherapy at the protocol-specified starting dose in the treatment group A (TGA), with subsequent cohort escalations in the three treatment groups (TGA, TGB, and TGC) based on protocol-specific criteria
Secondary
Objective Response Rate (ORR)
Defined as the percentage of subjects having complete response (CR) or partial response (PR). The best overall response was defined as the best response recorded before and including the first event of Progressive disease (PD).
As a result of early termination of the study, only participants in Part 2 of the study were evaluated; Treatment Group C was not evaluated due to early termination from the study.
Posted
Count of Participants
Participants
Baseline through end of study, up to 6 months
ID
Title
Description
OG000
Part 2 / Treatment Group A: 20 MG BID INCB054329
Part 2 / treatment group A (TGA): dose titration was to determine the feasibility of intraparticipant dose titration using Protocol-defined criteria. Treatment Group A included any advanced solid tumor or lymphoma.
OG001
Part 2 / Treatment Group C: 20 mg BID INCB054329
Part 2 / treatment group C (TGC): dose titration was to determine the feasibility of intraparticipant dose titration using Protocol-defined criteria. Treatment Group C included multiple myeloma.
Units
Counts
Participants
Secondary
Duration of Response (DOR)
Defined as the time from earliest date of disease response until earliest date of disease progression or death.
As a result of early termination of the study, there are no participants that are responders and therefore DOR was not achieved.
Posted
Baseline through end of study, up to 6 months
ID
Title
Description
OG000
Part 1 / Treatment Group A: 15 MG QD INCB054329
Part 1 / treatment group A (TGA): Initial cohort dose of INCB054329 monotherapy at the protocol-specified starting dose in the TGA. Treatment Group A included any advanced solid tumor or lymphoma.
OG001
Part 1 / Treatment Group A: 22.5 MG QD INCB054329
Part 1 / treatment group A (TGA): Initial cohort dose of INCB054329 monotherapy at the protocol-specified starting dose in the TGA. Treatment Group A included any advanced solid tumor or lymphoma.
OG002
Part 1 / Treatment Group A: 15 MG BID INCB054329
Part 1 / treatment group A (TGA): Initial cohort dose of INCB054329 monotherapy at the protocol-specified starting dose in the TGA. Treatment Group A included any advanced solid tumor or lymphoma.
OG003
Secondary
Progression Free Survival (PFS)
PFS is the time from start of study treatment to first documentation of progression, or to death due to any cause, whichever comes first
As a result of early termination of the study, only participants in Part 2 of the study were evaluated; Treatment Group C was not evaluated due to early termination from the study.
Posted
Median
95% Confidence Interval
months
Baseline through end of study, up to 6 months
ID
Title
Description
OG000
Part 2 / Treatment Group A: 20 MG BID INCB054329
Part 2 / treatment group A (TGA): dose titration was to determine the feasibility of intraparticipant dose titration using Protocol-defined criteria. Treatment Group A included any advanced solid tumor or lymphoma.
OG001
Part 2 / Treatment Group C: 20 mg BID INCB054329
Part 2 / treatment group C (TGC): dose titration was to determine the feasibility of intraparticipant dose titration using Protocol-defined criteria. Treatment Group C included multiple myeloma.
Units
Counts
Participants
Secondary
Overall Survival (OS)
OS is defined as the time from the date of randomization to the date of the participant's death.
As a result of early termination of the study, only participants in Part 2 of the study were evaluated; Treatment Group C was not evaluated due to early termination from the study.
Posted
Median
95% Confidence Interval
months
Baseline through end of study, up to 6 months for participants in Part 2
ID
Title
Description
OG000
Part 2 / Treatment Group A: 20 MG BID INCB054329
Part 2 / treatment group A (TGA): dose titration was to determine the feasibility of intraparticipant dose titration using Protocol-defined criteria. Treatment Group A included any advanced solid tumor or lymphoma.
OG001
Part 2 / Treatment Group C: 20 mg BID INCB054329
Part 2 / treatment group C (TGC): dose titration was to determine the feasibility of intraparticipant dose titration using Protocol-defined criteria. Treatment Group C included multiple myeloma.
Units
Counts
Participants
Time Frame
From the first dose of study medication up to 6 months or up to study termination date 31Jan2018. Follow-up data included up until database lock 11APR2018.
Description
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
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 / Treatment Group A: 15 MG QD INCB054329
Part 1 / treatment group A (TGA): Initial cohort dose of INCB054329 monotherapy at the protocol-specified starting dose in the TGA. Treatment Group A included any advanced solid tumor or lymphoma.
4
4
1
4
4
4
EG001
Part 1 / Treatment Group A: 22.5 MG QD INCB054329
Part 1 / treatment group A (TGA): Initial cohort dose of INCB054329 monotherapy at the protocol-specified starting dose in the TGA. Treatment Group A included any advanced solid tumor or lymphoma.
4
5
1
5
5
5
EG002
Part 1 / Treatment Group A: 15 MG BID INCB054329
Part 1 / treatment group A (TGA): Initial cohort dose of INCB054329 monotherapy at the protocol-specified starting dose in the TGA. Treatment Group A included any advanced solid tumor or lymphoma.
3
6
1
6
6
6
EG003
Part 1 / Treatment Group A: 30 MG QD INCB054329
Part 1 / treatment group A (TGA): Initial cohort dose of INCB054329 monotherapy at the protocol-specified starting dose in the TGA. Treatment Group A included any advanced solid tumor or lymphoma.
4
5
1
5
5
5
EG004
Part 1 / Treatment Group A: 22.5 MG BID INCB054329
Part 1 / treatment group A (TGA): Initial cohort dose of INCB054329 monotherapy at the protocol-specified starting dose in the TGA. Treatment Group A included any advanced solid tumor or lymphoma.
2
3
3
3
3
3
EG005
Part 1 / Treatment Group A: 22.5 MG BID 5/2 INCB054329
Part 1 / treatment group A (TGA): Initial cohort dose of INCB054329 monotherapy at the protocol-specified starting dose in the TGA. 5/2=5 days on/2 days off.
Treatment Group A included any advanced solid tumor or lymphoma.
2
4
3
4
4
4
EG006
Part 1 / Treatment Group A: 22.5 MG BID 4/3 INCB054329
Part 1 / treatment group A (TGA): Initial cohort dose of INCB054329 monotherapy at the protocol-specified starting dose in the TGA. 4/3=4 days on/3 days off. Treatment Group A included any advanced solid tumor or lymphoma.
3
4
1
4
4
4
EG007
Part 1 / Treatment Group A: 22.5 MG BID 7/7 INCB054329
Part 1 / treatment group A (TGA): Initial cohort dose of INCB054329 monotherapy at the protocol-specified starting dose in the TGA. 7/7=7 days on/7 days off. Treatment Group A included any advanced solid tumor or lymphoma.
1
3
1
3
3
3
EG008
Part 1 / Treatment Group A: 20 MG BID INCB054329
Part 1 / treatment group A (TGA): Initial cohort dose of INCB054329 monotherapy at the protocol-specified starting dose in the TGA. Treatment Group A included any advanced solid tumor or lymphoma.
6
8
3
8
8
8
EG009
Part 1 / Treatment Group A: 25 MG BID 5/2 INCB054329
Part 1 / treatment group A (TGA): Initial cohort dose of INCB054329 monotherapy at the protocol-specified starting dose in the TGA. 5/2=5 days on/2 days off. Treatment Group A included any advanced solid tumor or lymphoma.
6
8
3
8
8
8
EG010
Part 1 / Treatment Group A: 25 MG BID 7/7 INCB054329
Part 1 / treatment group A (TGA): Initial cohort dose of INCB054329 monotherapy at the protocol-specified starting dose in the TGA. 7/7=7 days on/7 days off. Treatment Group A included any advanced solid tumor or lymphoma.
3
4
1
4
2
4
EG011
Part 1 / Treatment Group B: 20 MG BID INCB054329
Part 1 / treatment group B (TGB): Initial cohort dose of INCB054329 monotherapy at the protocol-specified cohort escalation treatment group B (TGB), based on protocol-specific criteria. Treatment Group B included acute leukemia, myelodysplastic syndrome, myelodysplastic/myeloproliferative neoplasms, or myelofibrosis.
2
4
3
4
4
4
EG012
Part 2 / Treatment Group A: 20 MG BID INCB054329
Part 2 / treatment group A (TGA): dose titration was to determine the feasibility of intraparticipant dose titration using Protocol-defined criteria. Treatment Group A included any advanced solid tumor or lymphoma.
6
10
3
10
10
10
EG013
Part 2 / Treatment Group C: 20 mg BID INCB054329
Part 2 / treatment group C (TGC): dose titration was to determine the feasibility of intraparticipant dose titration using Protocol-defined criteria. Treatment Group C included multiple myeloma.
1
1
1
1
1
1
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected4 at risk
EG0011 affected5 at risk
EG0020 affected6 at risk
EG0031 affected5 at risk
EG0040 affected3 at risk
EG0051 affected4 at risk
EG0060 affected4 at risk
EG0070 affected3 at risk
EG0080 affected8 at risk
EG0090 affected8 at risk
EG0100 affected4 at risk
EG0110 affected4 at risk
EG0121 affected10 at risk
EG0131 affected1 at risk
Neutropenia
Blood and lymphatic system disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected6 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected4 at risk
EG0011 affected5 at risk
EG0020 affected6 at risk
EG003
Febrile neutropenia
Blood and lymphatic system disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected6 at risk
EG003
Vertigo
Ear and labyrinth disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected6 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected6 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected6 at risk
EG003
Gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected4 at risk
EG0011 affected5 at risk
EG0020 affected6 at risk
EG003
Ileus
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected6 at risk
EG003
Intra-abdominal haemorrhage
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected6 at risk
EG003
Large intestinal obstruction
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected6 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected6 at risk
EG003
Oesophagitis
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected6 at risk
EG003
Stomatitis
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected6 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected6 at risk
EG003
Fatigue
General disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected4 at risk
EG0011 affected5 at risk
EG0020 affected6 at risk
EG003
Multi-organ failure
General disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected6 at risk
EG003
Hepatic vein thrombosis
Hepatobiliary disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected6 at risk
EG003
Hyperbilirubinaemia
Hepatobiliary disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected6 at risk
EG003
Abdominal abscess
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected6 at risk
EG003
Abscess intestinal
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected6 at risk
EG003
Cellulitis
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected6 at risk
EG003
Escherichia bacteraemia
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected6 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected6 at risk
EG003
Septic shock
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected6 at risk
EG003
Staphylococcal bacteraemia
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected6 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA 18.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected6 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA 18.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected6 at risk
EG003
Blood bilirubin increased
Investigations
MedDRA 18.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected6 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected6 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected6 at risk
EG003
Flank pain
Musculoskeletal and connective tissue disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected6 at risk
EG003
Colon cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 18.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected6 at risk
EG003
Myelodysplastic syndrome
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 18.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected6 at risk
EG003
Encephalopathy
Nervous system disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected6 at risk
EG003
Seizure
Nervous system disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0021 affected6 at risk
EG003
Spinal cord compression
Nervous system disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected6 at risk
EG003
Syncope
Nervous system disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected6 at risk
EG003
Chronic obstructive pulmonary disease
Respiratory, thoracic and mediastinal disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected6 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected4 at risk
EG0010 affected5 at risk
EG0020 affected6 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected6 at risk
EG003
Hypoxia
Respiratory, thoracic and mediastinal disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected4 at risk
EG0010 affected5 at risk
EG0020 affected6 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected4 at risk
EG0010 affected5 at risk
EG0020 affected6 at risk
EG003
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected6 at risk
EG003
Respiratory failure
Respiratory, thoracic and mediastinal disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected4 at risk
EG0010 affected5 at risk
EG0020 affected6 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected4 at risk
EG0011 affected5 at risk
EG0020 affected6 at risk
EG0031 affected5 at risk
EG0041 affected3 at risk
EG0052 affected4 at risk
EG0061 affected4 at risk
EG0071 affected3 at risk
EG0083 affected8 at risk
EG0091 affected8 at risk
EG0101 affected4 at risk
EG0111 affected4 at risk
EG0121 affected10 at risk
EG0130 affected1 at risk
Lymphopenia
Blood and lymphatic system disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected6 at risk
EG003
Neutropenia
Blood and lymphatic system disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected6 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected4 at risk
EG0011 affected5 at risk
EG0020 affected6 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected4 at risk
EG0011 affected5 at risk
EG0021 affected6 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected4 at risk
EG0012 affected5 at risk
EG0021 affected6 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected4 at risk
EG0011 affected5 at risk
EG0021 affected6 at risk
EG003
Dry mouth
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected4 at risk
EG0010 affected5 at risk
EG0020 affected6 at risk
EG003
Dysphagia
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected4 at risk
EG0010 affected5 at risk
EG0020 affected6 at risk
EG003
Mouth haemorrhage
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected6 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected4 at risk
EG0012 affected5 at risk
EG0021 affected6 at risk
EG003
Stomatitis
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected4 at risk
EG0010 affected5 at risk
EG0020 affected6 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected4 at risk
EG0011 affected5 at risk
EG0021 affected6 at risk
EG003
Fatigue
General disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected4 at risk
EG0013 affected5 at risk
EG0021 affected6 at risk
EG003
Oedema peripheral
General disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected6 at risk
EG003
Pain
General disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected4 at risk
EG0011 affected5 at risk
EG0021 affected6 at risk
EG003
Pyrexia
General disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected6 at risk
EG003
Hyperbilirubinaemia
Hepatobiliary disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected6 at risk
EG003
Bacteraemia
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected6 at risk
EG003
Candida infection
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected6 at risk
EG003
Oral herpes
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected6 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0021 affected6 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA 18.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected6 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA 18.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0021 affected6 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA 18.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0021 affected6 at risk
EG003
Blood bilirubin increased
Investigations
MedDRA 18.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0021 affected6 at risk
EG003
Neutrophil count decreased
Investigations
MedDRA 18.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected6 at risk
EG003
Platelet count decreased
Investigations
MedDRA 18.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected6 at risk
EG003
Weight decreased
Investigations
MedDRA 18.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected6 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA 18.0
Systematic Assessment
EG0002 affected4 at risk
EG0013 affected5 at risk
EG0020 affected6 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0021 affected6 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected6 at risk
EG003
Hyperkalaemia
Metabolism and nutrition disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected6 at risk
EG003
Hyperphosphataemia
Metabolism and nutrition disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected6 at risk
EG003
Hypertriglyceridaemia
Metabolism and nutrition disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected6 at risk
EG003
Hyperuricaemia
Metabolism and nutrition disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected6 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected6 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected6 at risk
EG003
Hypophosphataemia
Metabolism and nutrition disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected6 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0021 affected6 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected4 at risk
EG0011 affected5 at risk
EG0021 affected6 at risk
EG003
Musculoskeletal pain
Musculoskeletal and connective tissue disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected4 at risk
EG0011 affected5 at risk
EG0022 affected6 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0022 affected6 at risk
EG003
Pain in jaw
Musculoskeletal and connective tissue disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected6 at risk
EG003
Dizziness
Nervous system disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected6 at risk
EG003
Dysgeusia
Nervous system disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected4 at risk
EG0011 affected5 at risk
EG0021 affected6 at risk
EG003
Headache
Nervous system disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected4 at risk
EG0011 affected5 at risk
EG0020 affected6 at risk
EG003
Neuropathy peripheral
Nervous system disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0021 affected6 at risk
EG003
Dysuria
Renal and urinary disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected6 at risk
EG003
Haematuria
Renal and urinary disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected6 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0021 affected6 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected4 at risk
EG0012 affected5 at risk
EG0020 affected6 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected6 at risk
EG003
Hypoxia
Respiratory, thoracic and mediastinal disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected4 at risk
EG0011 affected5 at risk
EG0020 affected6 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected6 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected6 at risk
EG003
Hypotension
Vascular disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected6 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected6 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected4 at risk
EG0011 affected5 at risk
EG0020 affected6 at risk
EG003
Leukopenia
Blood and lymphatic system disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected6 at risk
EG003
Tinnitus
Ear and labyrinth disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0021 affected6 at risk
EG003
Diplopia
Eye disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected6 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected4 at risk
EG0010 affected5 at risk
EG0020 affected6 at risk
EG003
Flatulence
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected6 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected6 at risk
EG003
Lip dry
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected4 at risk
EG0011 affected5 at risk
EG0020 affected6 at risk
EG003
Catheter site pain
General disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0021 affected6 at risk
EG003
Peripheral swelling
General disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0021 affected6 at risk
EG003
Oral candidiasis
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected6 at risk
EG003
Staphylococcal infection
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected6 at risk
EG003
Subcutaneous abscess
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected6 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0021 affected6 at risk
EG003
Procedural pain
Injury, poisoning and procedural complications
MedDRA 18.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0021 affected6 at risk
EG003
Blood creatinine increased
Investigations
MedDRA 18.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected6 at risk
EG003
Electrocardiogram ST segment elevation
Investigations
MedDRA 18.0
Systematic Assessment
EG0000 affected4 at risk
EG0011 affected5 at risk
EG0020 affected6 at risk
EG003
Hypoalbuminaemia
Metabolism and nutrition disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected4 at risk
EG0010 affected5 at risk
EG0020 affected6 at risk
EG003
Hypochloraemia
Metabolism and nutrition disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected6 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0021 affected6 at risk
EG003
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected4 at risk
EG0010 affected5 at risk
EG0020 affected6 at risk
EG003
Depression
Psychiatric disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected4 at risk
EG0011 affected5 at risk
EG0020 affected6 at risk
EG003
Disorientation
Psychiatric disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0021 affected6 at risk
EG003
Ureteric obstruction
Renal and urinary disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0021 affected6 at risk
EG003
Testicular pain
Reproductive system and breast disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected4 at risk
EG0011 affected5 at risk
EG0020 affected6 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected4 at risk
EG0010 affected5 at risk
EG0020 affected6 at risk
EG003
Pleuritic pain
Respiratory, thoracic and mediastinal disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected4 at risk
EG0010 affected5 at risk
EG0020 affected6 at risk
EG003
Rhinorrhoea
Respiratory, thoracic and mediastinal disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0021 affected6 at risk
EG003
Sinus congestion
Respiratory, thoracic and mediastinal disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected6 at risk
EG003
Sinus disorder
Respiratory, thoracic and mediastinal disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected4 at risk
EG0011 affected5 at risk
EG0020 affected6 at risk
EG003
Sputum increased
Respiratory, thoracic and mediastinal disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected4 at risk
EG0011 affected5 at risk
EG0020 affected6 at risk
EG003
Alopecia
Skin and subcutaneous tissue disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected6 at risk
EG003
Dry skin
Skin and subcutaneous tissue disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected4 at risk
EG0011 affected5 at risk
EG0020 affected6 at risk
EG003
Hyperhidrosis
Skin and subcutaneous tissue disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected4 at risk
EG0011 affected5 at risk
EG0020 affected6 at risk
EG003
Pain of skin
Skin and subcutaneous tissue disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected6 at risk
EG003
Night sweats
Skin and subcutaneous tissue disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected6 at risk
EG003
Palmar erythema
Skin and subcutaneous tissue disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected4 at risk
EG0011 affected5 at risk
EG0020 affected6 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected6 at risk
EG003
Rash pruritic
Skin and subcutaneous tissue disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected6 at risk
EG003
Skin discolouration
Skin and subcutaneous tissue disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected6 at risk
EG003
Hot flush
Vascular disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected4 at risk
EG0011 affected5 at risk
EG0021 affected6 at risk
EG003
Hypertension
Vascular disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected6 at risk
EG003
Flushing
Vascular disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected6 at risk
EG003
Lymphoedema
Vascular disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected6 at risk
EG003
Iron deficiency
Metabolism and nutrition disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected6 at risk
EG003
Palpitations
Cardiac disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected6 at risk
EG003
Sinus tachycardia
Cardiac disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected6 at risk
EG003
Gilbert's syndrome
Congenital, familial and genetic disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected6 at risk
EG003
Eye discharge
Eye disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected6 at risk
EG003
Eye irritation
Eye disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected6 at risk
EG003
Eye pain
Eye disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected6 at risk
EG003
Lacrimation increased
Eye disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected6 at risk
EG003
Abdominal distension
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected6 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected6 at risk
EG003
Ascites
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected6 at risk
EG003
Gastritis
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected6 at risk
EG003
Haemorrhoidal haemorrhage
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected6 at risk
EG003
Melaena
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected6 at risk
EG003
Odynophagia
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected6 at risk
EG003
Retching
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected6 at risk
EG003
Toothache
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected6 at risk
EG003
Axillary pain
General disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected6 at risk
EG003
Chills
General disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected6 at risk
EG003
Early satiety
General disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected6 at risk
EG003
Feeling hot
General disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected6 at risk
EG003
Hepatic pain
Hepatobiliary disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected6 at risk
EG003
Cellulitis
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected6 at risk
EG003
Conjunctivitis
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected6 at risk
EG003
Contusion
Injury, poisoning and procedural complications
MedDRA 18.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected6 at risk
EG003
Tooth fracture
Injury, poisoning and procedural complications
MedDRA 18.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected6 at risk
EG003
Blood alkaline phosphatase increased
Investigations
MedDRA 18.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected6 at risk
EG003
Blood phosphorus increased
Investigations
MedDRA 18.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected6 at risk
EG003
Blood magnesium decreased
Investigations
MedDRA 18.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected6 at risk
EG003
Lymphocyte count decreased
Investigations
MedDRA 18.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected6 at risk
EG003
Hypercholesterolaemia
Metabolism and nutrition disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected6 at risk
EG003
Hypomagnesaemia
Metabolism and nutrition disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected6 at risk
EG003
Flank pain
Musculoskeletal and connective tissue disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected6 at risk
EG003
Cognitive disorder
Nervous system disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected6 at risk
EG003
Speech disorder
Nervous system disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected6 at risk
EG003
Tremor
Nervous system disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected6 at risk
EG003
Restlessness
Psychiatric disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected6 at risk
EG003
Pollakiuria
Renal and urinary disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected6 at risk
EG003
Dyspnoea exertional
Respiratory, thoracic and mediastinal disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected6 at risk
EG003
Haemorrhage
Vascular disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected6 at risk
EG003
Hypovolaemic shock
Vascular disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected6 at risk
EG003
Ear pain
Ear and labyrinth disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected6 at risk
EG003
Eyelid oedema
Eye disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected6 at risk
EG003
Abdominal discomfort
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected6 at risk
EG003
Abdominal pain lower
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected6 at risk
EG003
Rectal haemorrhage
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected6 at risk
EG003
Asthenia
General disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected6 at risk
EG003
Feeling abnormal
General disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected6 at risk
EG003
Non-cardiac chest pain
General disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected6 at risk
EG003
Clostridium difficile infection
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected6 at risk
EG003
Herpes simplex
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected6 at risk
EG003
Herpes zoster
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected6 at risk
EG003
Laryngitis
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected6 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected6 at risk
EG003
Sinusitis
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected6 at risk
EG003
Urinary tract infection fungal
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected6 at risk
EG003
Viral upper respiratory tract infection
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected6 at risk
EG003
Vulvovaginal candidiasis
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected6 at risk
EG003
Blood potassium decreased
Investigations
MedDRA 18.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected6 at risk
EG003
Electrocardiogram QT prolonged
Investigations
MedDRA 18.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected6 at risk
EG003
Hypercalcaemia
Metabolism and nutrition disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected6 at risk
EG003
Hypocalcaemia
Metabolism and nutrition disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected6 at risk
EG003
Groin pain
Musculoskeletal and connective tissue disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected6 at risk
EG003
Musculoskeletal stiffness
Musculoskeletal and connective tissue disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected6 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected6 at risk
EG003
Neck pain
Musculoskeletal and connective tissue disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected6 at risk
EG003
Spinal pain
Musculoskeletal and connective tissue disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected6 at risk
EG003
Tumour haemorrhage
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 18.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected6 at risk
EG003
Balance disorder
Nervous system disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected6 at risk
EG003
Dizziness
Nervous system disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected6 at risk
EG003
Embolic stroke
Nervous system disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected6 at risk
EG003
Paraesthesia
Nervous system disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected6 at risk
EG003
Peroneal nerve palsy
Nervous system disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected6 at risk
EG003
Seizure
Nervous system disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected6 at risk
EG003
Apathy
Psychiatric disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected6 at risk
EG003
Confusional state
Psychiatric disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected6 at risk
EG003
Hallucination
Psychiatric disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected6 at risk
EG003
Acute kidney injury
Renal and urinary disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected6 at risk
EG003
Urinary incontinence
Renal and urinary disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected6 at risk
EG003
Vaginal discharge
Reproductive system and breast disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected6 at risk
EG003
Vaginal haemorrhage
Reproductive system and breast disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected6 at risk
EG003
Nasal congestion
Respiratory, thoracic and mediastinal disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected6 at risk
EG003
Productive cough
Respiratory, thoracic and mediastinal disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected6 at risk
EG003
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected6 at risk
EG003
Wheezing
Respiratory, thoracic and mediastinal disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected6 at risk
EG003
Decubitus ulcer
Skin and subcutaneous tissue disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected6 at risk
EG003
Erythema
Skin and subcutaneous tissue disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected6 at risk
EG003
Palmar-plantar erythrodysaesthesia syndrome
Skin and subcutaneous tissue disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected6 at risk
EG003
Papule
Skin and subcutaneous tissue disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected6 at risk
EG003
Rash macular
Skin and subcutaneous tissue disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected6 at risk
EG003
Rash maculo-papular
Skin and subcutaneous tissue disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected6 at risk
EG003
Eyelid oedema
Eye disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected6 at risk
EG003
Oral pain
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected6 at risk
EG003
Muscular weakness
Musculoskeletal and connective tissue disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected6 at risk
EG003
Iron deficiency anaemia
Blood and lymphatic system disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected6 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
Following the first publication, the Institution and/or Principal Investigator may publish data or results from the Study, provided, however, that the Institution and/or Principal Investigator submits the proposed publication to the Sponsor for review at least sixty (60) days prior to the date of the proposed publication. Sponsor may remove from the proposed publication any information that is considered confidential and/or proprietary other than Study data and results.
OG007NA± NADose dependent parameter and overall summary not provided.
INCB054329 Monotherapy
OG005
INCB054329 Monotherapy - 22.5 mg BID
INCB054329 Monotherapy
OG006
INCB054329 Monotherapy - 25 mg BID
INCB054329 Monotherapy
OG007
INCB054329 Monotherapy - Overall Dosing Regimen
INCB054329 Monotherapy
Units
Counts
Participants
OG0004
OG0015
OG0024
OG0034
OG00414
OG00512
OG0068
OG00751
Title
Denominators
Categories
Title
Measurements
OG0001.0(0.52 to 1.0)
OG0010.93(0.5 to 1.1)
OG0020.53(0.5 to 1.0)
OG0031.0(0.52 to 1.0)
OG0041.0(0.48 to 2.0)
OG0051.0(0.5 to 4.1)
OG0060.77(0.50 to 2.2)
OG0071.0(0.48 to 4.1)
INCB054329 Monotherapy - 20 mg BID
INCB054329 Monotherapy
OG005
INCB054329 Monotherapy - 22.5 mg BID
INCB054329 Monotherapy
OG006
INCB054329 Monotherapy - 25 mg BID
INCB054329 Monotherapy
OG007
INCB054329 Monotherapy - Overall Dosing Regimen
INCB054329 Monotherapy
Units
Counts
Participants
OG0004
OG0015
OG0024
OG0034
OG00413
OG00512
OG0067
OG00749
Title
Denominators
Categories
Title
Measurements
OG0000.538± 1.08
OG0011.09± 2.45
OG0020± 0
OG0031.51± 3.02
OG00454.2± 91.1
OG00514.6± 45
OG0060± 0
OG007NA± NADose dependent parameter and overall summary not provided.
INCB054329 Monotherapy
OG005
INCB054329 Monotherapy - 22.5 mg BID
INCB054329 Monotherapy
OG006
INCB054329 Monotherapy - 25 mg BID
INCB054329 Monotherapy
OG007
INCB054329 Monotherapy - Overall Dosing Regimen
INCB054329 Monotherapy
Units
Counts
Participants
OG0004
OG0015
OG0024
OG0034
OG00414
OG00512
OG0068
OG00751
Title
Denominators
Categories
Title
Measurements
OG000686± 178
OG001611± 628
OG002883± 409
OG0031150± 1660
OG0042130± 1690
OG0051970± 1560
OG006995± 843
OG007NA± NADose dependent parameter and overall summary not provided.
INCB054329 Monotherapy
OG005
INCB054329 Monotherapy - 22.5 mg QD
INCB054329 Monotherapy
OG006
INCB054329 Monotherapy - 25 mg BID
INCB054329 Monotherapy
OG007
INCB054329 Monotherapy - Overall Dosing Regimen
INCB054329 Monotherapy
Units
Counts
Participants
OG0004
OG0014
OG0024
OG0034
OG00414
OG00511
OG0067
OG00748
Title
Denominators
Categories
Title
Measurements
OG00061.8± 21.3
OG00185.0± 42.9
OG00281.7± 29.4
OG003234± 184
OG00492.3± 201
OG00548.3± 33.7
OG006130± 127
OG00795.5± 135
Units
Counts
Participants
OG00049
Title
Denominators
Categories
Title
Measurements
OG000283.4
OG00010
OG0010
Title
Denominators
Categories
Title
Measurements
Complete response (CR)
OG0000
Partial response (PR)
OG0000
Stable disease (SD) >= 6 months
OG0000
Stable disease (SD) < 6 months
OG0004
Progressive disease (PD)
OG0005
Not evaluable (NE)
OG0001
Part 1 / Treatment Group A: 30 MG QD INCB054329
Part 1 / treatment group A (TGA): Initial cohort dose of INCB054329 monotherapy at the protocol-specified starting dose in the TGA. Treatment Group A included any advanced solid tumor or lymphoma.
OG004
Part 1 / Treatment Group A: 22.5 MG BID INCB054329
Part 1 / treatment group A (TGA): Initial cohort dose of INCB054329 monotherapy at the protocol-specified starting dose in the TGA. Treatment Group A included any advanced solid tumor or lymphoma.
OG005
Part 1 / Treatment Group A: 22.5 MG BID 5/2 INCB054329
Part 1 / treatment group A (TGA): Initial cohort dose of INCB054329 monotherapy at the protocol-specified starting dose in the TGA. 5/2=5 days on/2 days off.
Treatment Group A included any advanced solid tumor or lymphoma.
OG006
Part 1 / Treatment Group A: 22.5 MG BID 4/3 INCB054329
Part 1 / treatment group A (TGA): Initial cohort dose of INCB054329 monotherapy at the protocol-specified starting dose in the TGA. 4/3=4 days on/3 days off. Treatment Group A included any advanced solid tumor or lymphoma.
OG007
Part 1 / Treatment Group A: 22.5 MG BID 7/7 INCB054329
Part 1 / treatment group A (TGA): Initial cohort dose of INCB054329 monotherapy at the protocol-specified starting dose in the TGA. 7/7=7 days on/7 days off. Treatment Group A included any advanced solid tumor or lymphoma.
OG008
Part 1 / Treatment Group A: 20 MG BID INCB054329
Part 1 / treatment group A (TGA): Initial cohort dose of INCB054329 monotherapy at the protocol-specified starting dose in the TGA. Treatment Group A included any advanced solid tumor or lymphoma.
OG009
Part 1 / Treatment Group A: 25 MG BID 5/2 INCB054329
Part 1 / treatment group A (TGA): Initial cohort dose of INCB054329 monotherapy at the protocol-specified starting dose in the TGA. 5/2=5 days on/2 days off. Treatment Group A included any advanced solid tumor or lymphoma.
OG010
Part 1 / Treatment Group A: 25 MG BID 7/7 INCB054329
Part 1 / treatment group A (TGA): Initial cohort dose of INCB054329 monotherapy at the protocol-specified starting dose in the TGA. 7/7=7 days on/7 days off. Treatment Group A included any advanced solid tumor or lymphoma.
OG011
Part 1 / Treatment Group B: 20 MG BID INCB054329
Part 1 / treatment group B (TGB): Initial cohort dose of INCB054329 monotherapy at the protocol-specified cohort escalation treatment group B (TGB), based on protocol-specific criteria. Treatment Group B included acute leukemia, myelodysplastic syndrome, myelodysplastic/myeloproliferative neoplasms, or myelofibrosis.
OG012
Part 2 / Treatment Group A: 20 MG BID INCB054329
Part 2 / treatment group A (TGA): dose titration was to determine the feasibility of intraparticipant dose titration using Protocol-defined criteria. Treatment Group A included any advanced solid tumor or lymphoma.
OG013
Part 2 / Treatment Group C: 20 mg BID INCB054329
Part 2 / treatment group C (TGC): dose titration was to determine the feasibility of intraparticipant dose titration using Protocol-defined criteria. Treatment Group C included multiple myeloma.
Units
Counts
Participants
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
OG0080
OG0090
OG0100
OG0110
OG0120
OG0130
OG00010
OG0010
Title
Denominators
Categories
Title
Measurements
OG0002.04(0.63 to 4.21)
OG00010
OG0010
Title
Denominators
Categories
Title
Measurements
OG0007.09(3.13 to NA)The upper CI limit of median PFS could not be estimated by the Brookmeyer and Crowley method because there were not enough events.