Open-Label Safety and Tolerability Study of INCB057643 in... | NCT02711137 | Trialant
NCT02711137
Sponsor
Incyte Corporation
Status
Terminated
Last Update Posted
Oct 21, 2025Actual
Enrollment
137Actual
Phase
Phase 1Phase 2
Conditions
Solid Tumors
Interventions
INCB057643
Gemcitabine
Paclitaxel
Rucaparib
Abiraterone
Ruxolitinib
Azacitidine
Countries
United States
Belgium
France
Protocol Section
Identification Module
NCT ID
NCT02711137
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
INCB 57643-101
Secondary IDs
ID
Type
Description
Link
2017-002641-29
EudraCT Number
Brief Title
Open-Label Safety and Tolerability Study of INCB057643 in Subjects With Advanced Malignancies
Official Title
A Phase 1/2, Open-Label, Dose-Escalation/Dose-Expansion, Safety and Tolerability Study of INCB057643 in Subjects With Advanced Malignancies
Acronym
Not provided
Organization
Incyte CorporationINDUSTRY
Status Module
Record Verification Date
Oct 2025
Overall Recruitment Status or Expanded Access Status
Terminated
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Study terminated due to safety issues.
Expanded Access Info
No
Start Date
May 18, 2016Actual
Primary Completion Date
Feb 13, 2019Actual
Completion Date
Feb 13, 2019Actual
First Submitted Date
Mar 9, 2016
First Submission Date that Met QC Criteria
Mar 12, 2016
First Posted Date
Mar 17, 2016Estimated
Results Waived
Not provided
Results First Submitted Date
Feb 11, 2022
Results First Submitted that Met QC Criteria
Apr 1, 2022
Results First Posted Date
Apr 28, 2022Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Feb 12, 2020
Certification/Extension First Submitted that Passed QC Review
Feb 12, 2020
Certification/Extension First Posted Date
Feb 17, 2020Actual
Last Update Submitted Date
Oct 20, 2025
Last Update Posted Date
Oct 21, 2025Actual
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
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
The purpose of the Study is to select a dose and assess the safety and tolerability of INCB057643 as a monotherapy (Part 1 and Part 2) and in combination with standard-of-care (SOC) agents (Part 3 and Part 4) for subjects with advanced malignancies.
Part 1 will determine the maximum tolerated dose of INCB057643 and/or a tolerated dose that demonstrates sufficient pharmacologic activity. Part 2 will further evaluate the safety, preliminary efficacy, PK, and PD of the dose(s) selected in Part 1 in select tumor types including solid tumors, lymphomas and other hematologic malignancies. Part 3 will determine the tolerated dose of INCB057643 in combination with select SOC agents; and assess the safety and tolerability of the combination therapy in select advanced solid tumors and hematologic malignancies. Part 4 will further evaluate the safety, preliminary efficacy, PK, and PD of the selected dose combination from Part 3 in 4 specific advanced solid tumor and hematologic malignancies.
Detailed Description
Not provided
Conditions Module
Conditions
Solid Tumors
Keywords
Solid tumor
lymphoma
leukemia
AML
myelodysplastic syndrome (MDS)
multiple myeloma
myeloproliferative neoplasm (MPN)
MDS/MPN
myelofibrosis (MF)
pancreatic cancer
colorectal cancer
non-small cell lung cancer
prostate cancer
breast cancer
ovarian cancer
glioblastoma multiforme (GBM)
NUT midline carcinoma
non-Hodgkin lymphoma
diffuse large B-cell lymphoma (DLBCL)
double-hit
triple-hit
myc
bromodomain and extra-terminal (BET) inhibitor
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 1Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
137Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Part1/Treatment Group A : 8mg QD INCB057643
Experimental
Initial cohort dose of INCB057643 monotherapy at the protocol specified starting dose in the TGA.
Treatment Group A included solid tumors and lymphoma
Drug: INCB057643
Part1/Treatment Group A : 12mg QD INCB057643
Experimental
Initial cohort dose of INCB057643 monotherapy at the protocol specified starting dose in the TGA.
Treatment Group A included solid tumors and lymphoma
Drug: INCB057643
Part1/Treatment Group A : 16mg QD INCB057643
Experimental
Initial cohort dose of INCB057643 monotherapy at the protocol specified starting dose in the TGA.
Treatment Group A included solid tumors and lymphoma
Drug: INCB057643
Part1/Treatment Group B : 8mg QD INCB057643
Experimental
Initial cohort dose of INCB054763 monotherapy at the protocol-specified cohort escalation treatment group B (TGB), based on protocol-specific criteria. Treatment Group B included any acute leukemia, HRMDS, MDS/MPN, or MF
Drug: INCB057643
Part1/Treatment Group B : 12mg QD INCB057643
Experimental
Initial cohort dose of INCB054763 monotherapy at the protocol-specified cohort escalation treatment group B (TGB), based on protocol-specific criteria. Treatment Group B included any acute leukemia, HRMDS, MDS/MPN, or MF.
Interventions
Name
Type
Description
Arm Group Labels
Other Names
INCB057643
Drug
Initial cohort dose of INCB057643 at the protocol-specified starting dose (Part 1), with subsequent dose escalations based on protocol-specific criteria. The recommended treatment group-specific dose(s) will be taken forward into expansion cohorts (Part 2).
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Number of Participants With Treatment Emergent Adverse Events (TEAE's).
Adverse events reported for the first time or worsening of a pre-existing event after first dose of study drug/treatment.
From screening through at least 30 days after end of treatment, up to approximately 24 months
Secondary Outcomes
Measure
Description
Time Frame
Percent Inhibition of Total Cellular Myc Protein Concentrations Before and After Administration of INCB057643 When Administered as Monotherapy in an Ex-vivo Assay
An ex vivo assay (utilized in monotherapy only), Measuring Total c-Myc protein expressed from an exogenously added cell line (KMS12BM) to patient plasma, before and after administration of INCB057643.
PD in plasma at pre-dose and 0.5, 1, 2, 4, 6 and 8 hours postdose, for C1D1 and C1D8, and 24hrs post dose for C1D1
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Histologically or cytologically confirmed diagnosis of relapsed or refractory advanced or metastatic malignancies:
Part 1: solid tumors or lymphomas, or hematologic malignancies
Part 2: histologically confirmed disease in specific tumor types
Part 3: advanced solid tumor or hematologic malignancy
Part 4: select advanced solid tumor or hematologic malignancy
For Part 1 and 2, subjects must have progressed following at least 1 line of prior therapy and there is no further established therapy that is known to provide clinical benefit (including subjects who are intolerant to the established therapy)
For Parts 3 and 4, subjects must have progressed following at least 1 line of prior therapy, and the treatment with the select SOC agent is relevant for the specific disease cohort.
Life expectancy > 12 weeks, for MF subjects in Parts 3 and 4, life expectancy > 24 weeks
Eastern Cooperative Oncology Group (ECOG) performance status
Parts 1 and 3: 0 or 1
Parts 2 and 4: 0, 1, or 2
Willingness to avoid pregnancy or fathering children
Exclusion Criteria:
Inadequate bone marrow function per protocol-specified hemoglobin, platelet count, and absolute neutrophil count
Inadequate organ function per protocol-specified total bilirubin, AST and ALT, creatinine clearance and alkaline phosphatase.
Receipt of anticancer medications or investigational drugs within protocol-specified intervals
Unless approved by the medical monitor, may not have received an allogeneic hematopoietic stem cell transplant within 6 months before treatment, or have active graft-versus-host-disease following allogeneic transplant
Unless approved by the medical monitor, may not have received autologous hematopoietic stem cell transplant within 3 months before treatment
Any unresolved toxicity ≥ Grade 2 (except stable Grade 2 peripheral neuropathy or alopecia) from previous anticancer therapy
Radiotherapy within the 2 weeks before initiation of treatment. Palliative radiation treatment to nonindex or bone lesions performed less than 2 weeks before treatment initiation may be considered with medical monitor approval
Currently active and uncontrolled infectious disease requiring systemic antibiotic, antifungal, or antiviral treatment
Untreated brain or central nervous system (CNS) metastases or brain/CNS metastases that have progressed
History or presence of abnormal electrocardiogram (ECG) that, in the investigator's opinion, is clinically meaningful
Type 1 diabetes or uncontrolled Type 2 diabetes
HbA1c of ≥ 8% (all subjects will have HbA1c test at screening)
Any sign of clinically significant bleeding
Coagulation panel within protocol-specified parameters
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
Subjects were assigned to either dose escalation/dose-expansion study of INCB057643 as monotherapy or in combination with SOC agents in subjects with relapsing or refractory malignancies.
Recruitment Details
A total of 137 subjects enrolled at 19 different sites in USA.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Part1/Treatment Group A : 8mg QD INCB057643
Initial cohort dose of INCB057643 monotherapy at the protocol specified starting dose in the TGA.
Treatment Group A included solid tumors and lymphoma
FG001
Part1/Treatment Group A : 12mg QD INCB057643
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Not provided
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Not provided
Uploaded Document Information
Type
Includes Protocol
Includes SAP
Includes ICF
Document Label
Document Date
Document Uploaded Date
Document File Name
Prot_SAP
Yes
Yes
No
Study Protocol and Statistical Analysis Plan
Oct 22, 2018
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
MeSH Terms
Non-Randomized
Intervention Model
Single Group 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
Drug: INCB057643
Part1/Treatment Group C : 8mg QD INCB057643
Experimental
Initial cohort dose of INCB054763 monotherapy at the protocol-specified cohort escalation treatment group C (TGC), based on protocol-specific criteria. Treatment Group C includes subjects with MM
Drug: INCB057643
Part2/Treatment Group A : 12 mg INCB057643 Expansion Cohort
Experimental
Initial cohort dose of INCB054763 monotherapy at the specified RP2D dose selected in Part 1 cohort escalation treatment group A (TGA), based on protocol-specific criteria. Part 2 Treatment Group A expansion included pancreatic adenocarcinoma, castration-resistant prostrate cancer, breast cancer, high grade serious ovarian cancer, glioblastoma multiform, non-hodgkin's lymphoma, ewing's sarcoma, and solid tumor or lymphoma.
Drug: INCB057643
Part2/Treatment Group B : 12 mg INCB057643 Expansion Cohort
Experimental
Initial cohort dose of INCB057463 monotherapy at the specified RP2D dose selected in Part 1 cohort escalation treatment group B (TGB), based on protocol-specific criteria. Part 2 Treatment Group B expansion included pancreatic adenocarcinoma, castration-resistant prostrate cancer, breast cancer, high grade serious ovarian cancer, glioblastoma multiform, non-hodgkin's lymphoma, ewing's sarcoma, and solid tumor or lymphoma.
Drug: INCB057643
Part3/Treatment Group A : 8 mg INCB057643 + Gemcitabine 1000mg
Experimental
Initial cohort dose of INCB057643 monotherapy based on protocol-specific criteria. Part 3 will determine the MTD and/or a tolerated dose of the combination of INCB057643 and one of the SOC agents (Gemcitabine) in relapsed or refractory advanced or metastatic solid tumors and hematologic malignancies where Gemcitabine is relevant
Drug: INCB057643
Drug: Gemcitabine
Part3/Treatment Group B : 8 mg INCB057643 + Paclitaxel 80mg
Experimental
Initial cohort dose of INCB054763 monotherapy based on protocol-specific criteria. Part 3 will determine the MTD and/or a tolerated dose of the combination of INCB057643 and one of the SOC agents (Paclitaxel) in relapsed or refractory advanced or metastatic solid tumors and hematologic malignancies.
Drug: INCB057643
Drug: Paclitaxel
Part3/Treatment Group C : 8 mg INCB057643 + Rucaparib 600mg
Experimental
Initial cohort dose of INCB054763 monotherapy based on protocol-specific criteria. Part 3 will determine the MTD and/or a tolerated dose of the combination of INCB057643 and one of the SOC agents (Rucaparib) in relapsed or refractory advanced or metastatic solid tumors and hematologic malignancies.
Drug: INCB057643
Drug: Rucaparib
Part3/Treatment Group D : 8 mg INCB057643 + Abir +Predni
Experimental
Initial cohort dose of INCB054763 monotherapy based on protocol-specific criteria. Part 3 will determine the MTD and/or a tolerated dose of the combination of INCB057643 and one of the SOC agents (Abiraterone + Prednisone) in Castration Resistant Prostrate Cancer
Drug: INCB057643
Drug: Abiraterone
Part3/Treatment Group E : 8 mg INCB057643 + Ruxolitinib 20mg
Experimental
Initial cohort dose of INCB054763 monotherapy based on protocol-specific criteria. Part 3 will determine the MTD and/or a tolerated dose of the combination of INCB057643 and one of the SOC agents (Ruxolitinib) in Myelofibrosis.
Drug: INCB057643
Drug: Ruxolitinib
Part3/Treatment Group F : 8 mg INCB057643 + Azacitidine 75mg
Experimental
Initial cohort dose of INCB054763 monotherapy based on protocol-specific criteria. Part 3 will determine the MTD and/or a tolerated dose of the combination of INCB057643 and one of the SOC agents (Azacitidine) in Acute Myeloid Leukemia and Myelodysplastic Syndrome
Drug: INCB057643
Drug: Azacitidine
Part1/Treatment Group A : 12mg QD INCB057643
Part1/Treatment Group A : 16mg QD INCB057643
Part1/Treatment Group A : 8mg QD INCB057643
Part1/Treatment Group B : 12mg QD INCB057643
Part1/Treatment Group B : 8mg QD INCB057643
Part1/Treatment Group C : 8mg QD INCB057643
Part2/Treatment Group A : 12 mg INCB057643 Expansion Cohort
Part2/Treatment Group B : 12 mg INCB057643 Expansion Cohort
Part3/Treatment Group A : 8 mg INCB057643 + Gemcitabine 1000mg
Part3/Treatment Group B : 8 mg INCB057643 + Paclitaxel 80mg
Part3/Treatment Group C : 8 mg INCB057643 + Rucaparib 600mg
Part3/Treatment Group D : 8 mg INCB057643 + Abir +Predni
Part3/Treatment Group E : 8 mg INCB057643 + Ruxolitinib 20mg
Part3/Treatment Group F : 8 mg INCB057643 + Azacitidine 75mg
Gemcitabine
Drug
Standard of Care (SOC) agents
Part3/Treatment Group A : 8 mg INCB057643 + Gemcitabine 1000mg
Paclitaxel
Drug
Standard of Care (SOC) agents
Part3/Treatment Group B : 8 mg INCB057643 + Paclitaxel 80mg
Rucaparib
Drug
Standard of Care (SOC) agents
Part3/Treatment Group C : 8 mg INCB057643 + Rucaparib 600mg
Abiraterone
Drug
Standard of Care (SOC) agents
Part3/Treatment Group D : 8 mg INCB057643 + Abir +Predni
Ruxolitinib
Drug
Standard of Care (SOC) agents
Part3/Treatment Group E : 8 mg INCB057643 + Ruxolitinib 20mg
Azacitidine
Drug
Standard of Care (SOC) agents
Part3/Treatment Group F : 8 mg INCB057643 + Azacitidine 75mg
Objective Response Rate (ORR) With INCB057643 in Solid Tumors
Objective response rate is defined as the proportion of subjects who have an objective response using the applicable disease assessment criteria. ORR was proportion of participants with best overall response [complete response (CR) or partial response (PR)].
Efficacy measures from screening through end of treatment and follow-up (every 9 weeks), up to approximately 24 months
Cmax: Maximum Observed Plasma Concentration of INCB057643.
Maximum Observed Plasma Concentration INCB057643 administered as monotherapy in fasted state.
Predose, 0.5, 1, 2, 4, 6, 8 hours on C1D1 and C1D8
Tmax: Time to Maximum Plasma Concentration of INCB057643
Time to maximum plasma concentration of INCB057643 administered as monotherapy in fasted state
Predose, 0.5, 1, 2, 4, 6, 8 hours on C1D1 and C1D8
AUC0-t: Area Under the Single-dose Plasma Concentration-time Curve of INCB057643
Area under the single-dose plasma concentration-time curve from Hour 0 to the last quantifiable measurable plasma concentration of INCB057643 administered as monotherapy in fasted state
Predose, 0.5, 1, 2, 4, 6, 8 hours on C1D1
AUC0-24: Area Under the Steady-state Plasma Concentration-time Curve of INCB057643 Administered as Monotherapy
Area under the steady-state plasma concentration-time curve over 1 dosing interval from Hour 0 to 24 for QD administration of INCB057643 administered as monotherapy in fasted state
Predose, 0.5, 1, 2, 4, 6, 8 hours on C1D8
Part 2 - Cmax: Maximum Observed Plasma Concentration of INCB057643.
Maximum Observed Plasma Concentration INCB057643 administered as monotherapy in fed state.
C2D1
Part 2-Tmax: Time to Maximum Plasma Concentration of INCB057643
Time to maximum plasma concentration of INCB057643 administered as monotherapy in fed state
C2D1
AUC0-24: Area Under the Steady-state Plasma Concentration-time Curve of INCB057643 Administered as Monotherapy
Area under the steady-state plasma concentration-time curve over 1 dosing interval from Hour 0 to 24 for QD administration of INCB057643 administered as monotherapy in fed state.
C2D1
La Jolla
California
92093
United States
Sarah Cannon Research Institute at Health One
Denver
Colorado
80218
United States
Yale University
New Haven
Connecticut
06510
United States
Sylvester Comprehensive Cancer Center
Miami
Florida
33136
United States
Hematology - Oncology Associates of Treasure Coast
Port Saint Lucie
Florida
34952
United States
University of Michigan
Ann Arbor
Michigan
48109
United States
University of Minnesota
Minneapolis
Minnesota
55455
United States
Washington University
St Louis
Missouri
63110
United States
University of Rochester, Wilmot Cancer Center
Rochester
New York
14642
United States
University of North Carolina at Chapel Hill
Chapel Hill
North Carolina
27599
United States
Wake Forest Baptist Health
Winston-Salem
North Carolina
27157
United States
Oncology Consultants, P.A.
Houston
Texas
77030
United States
The Methodist Hospital
Houston
Texas
77030
United States
Huntsman Cancer Institute
Salt Lake City
Utah
84112
United States
MultiCare Institute for Research and Innovation
Tacoma
Washington
98405
United States
Institut Jules Bordet, Clinical Trial Conduct Unit
Brussels
B-1000
Belgium
HÔPITAL SAINT-LOUIS, Service Hématologie Adultes
Paris
75010
France
Initial cohort dose of INCB057643 monotherapy at the protocol specified starting dose in the TGA.
Treatment Group A included solid tumors and lymphoma
FG002
Part1/Treatment Group A : 16mg QD INCB057643
Initial cohort dose of INCB057643 monotherapy at the protocol specified starting dose in the TGA.
Treatment Group A included solid tumors and lymphoma
FG003
Part1/Treatment Group B : 8mg QD INCB057643
Initial cohort dose of INCB054763 monotherapy at the protocol-specified cohort escalation treatment group B (TGB), based on protocol-specific criteria. Treatment Group B included any acute leukemia, HRMDS, MDS/MPN, or MF
FG004
Part1/Treatment Group B : 12mg QD INCB057643
Initial cohort dose of INCB054763 monotherapy at the protocol-specified cohort escalation treatment group B (TGB), based on protocol-specific criteria. Treatment Group B included any acute leukemia, HRMDS, MDS/MPN, or MF.
FG005
Part1/Treatment Group C : 8mg QD INCB057643
Initial cohort dose of INCB054763 monotherapy at the protocol-specified cohort escalation treatment group C (TGC), based on protocol-specific criteria. Treatment Group C includes subjects with MM
FG006
Part2/Treatment Group A : 12 mg INCB057643 Expansion Cohort
Initial cohort dose of INCB054763 monotherapy at the specified RP2D dose selected in Part 1 cohort escalation treatment group A (TGA), based on protocol-specific criteria. Part 2 Treatment Group A expansion included pancreatic adenocarcinoma, castration-resistant prostrate cancer, breast cancer, high grade serious ovarian cancer, glioblastoma multiform, non-hodgkin's lymphoma, ewing's sarcoma, and solid tumor or lymphoma.
FG007
Part2/Treatment Group B : 12 mg INCB057643 Expansion Cohort
Initial cohort dose of INCB057463 monotherapy at the specified RP2D dose selected in Part 1 cohort escalation treatment group B (TGB), based on protocol-specific criteria. Part 2 Treatment Group B expansion included pancreatic adenocarcinoma, castration-resistant prostrate cancer, breast cancer, high grade serious ovarian cancer, glioblastoma multiform, non-hodgkin's lymphoma, ewing's sarcoma, and solid tumor or lymphoma.
FG008
Part3/Treatment Group A : 8 mg INCB057643 + Gemcitabine 1000mg
Initial cohort dose of INCB057643 monotherapy based on protocol-specific criteria. Part 3 will determine the MTD and/or a tolerated dose of the combination of INCB057643 and one of the SOC agents (Gemcitabine) in relapsed or refractory advanced or metastatic solid tumors and hematologic malignancies where Gemcitabine is relevant
FG009
Part3/Treatment Group B : 8 mg INCB057643 + Paclitaxel 80mg
Initial cohort dose of INCB054763 monotherapy based on protocol-specific criteria. Part 3 will determine the MTD and/or a tolerated dose of the combination of INCB057643 and one of the SOC agents (Paclitaxel) in relapsed or refractory advanced or metastatic solid tumors and hematologic malignancies.
FG010
Part3/Treatment Group C : 8 mg INCB057643 + Rucaparib 600mg
Initial cohort dose of INCB054763 monotherapy based on protocol-specific criteria. Part 3 will determine the MTD and/or a tolerated dose of the combination of INCB057643 and one of the SOC agents (Rucaparib) in relapsed or refractory advanced or metastatic solid tumors and hematologic malignancies.
FG011
Part3/Treatment Group D : 8 mg INCB057643 + Abir +Predni
Initial cohort dose of INCB054763 monotherapy based on protocol-specific criteria. Part 3 will determine the MTD and/or a tolerated dose of the combination of INCB057643 and one of the SOC agents (Abiraterone + Prednisone) in Castration Resistant Prostrate Cancer
FG012
Part3/Treatment Group E : 8 mg INCB057643 + Ruxolitinib 20mg
Initial cohort dose of INCB054763 monotherapy based on protocol-specific criteria. Part 3 will determine the MTD and/or a tolerated dose of the combination of INCB057643 and one of the SOC agents (Ruxolitinib) in Myelofibrosis.
FG013
Part3/Treatment Group F : 8 mg INCB057643 + Azacitidine 75mg
Initial cohort dose of INCB054763 monotherapy based on protocol-specific criteria. Part 3 will determine the MTD and/or a tolerated dose of the combination of INCB057643 and one of the SOC agents (Azacitidine) in Acute Myeloid Leukemia and Myelodysplastic Syndrome
FG014
Enrolled But Not Dosed
3 participants enrolled in the study and discontinued the study before study drug is administered
FG0004 subjects
FG0015 subjects
FG0028 subjects
FG0037 subjects
FG0045 subjects
FG0051 subjects
FG00686 subjects
FG0075 subjects
FG0081 subjects
FG0092 subjects
FG0104 subjects
FG0113 subjects
FG0121 subjects
FG0132 subjects
FG0143 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
FG0140 subjects
NOT COMPLETED
FG0004 subjects
FG0015 subjects
FG0028 subjects
FG0037 subjects
FG0045 subjects
FG0051 subjects
FG00686 subjects
FG0075 subjects
FG0081 subjects
FG0092 subjects
FG0104 subjects
FG0113 subjects
FG0121 subjects
FG0132 subjects
FG0143 subjects
Type
Comment
Reasons
Death
FG0001 subjects
FG0014 subjects
FG0025 subjects
FG0035 subjects
FG0043 subjects
FG0051 subjects
FG00661 subjects
FG0073 subjects
FG0080 subjects
FG0091 subjects
FG0101 subjects
FG0111 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
Study Terminated by Sponsor
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG004
Physician Decision
FG0001 subjects
FG0010 subjects
FG0022 subjects
FG0031 subjects
FG004
Other
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG004
Withdrawal by Subject
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG004
Lost to Follow-up
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Part1/Treatment Group A : 8mg QD INCB057643
Initial cohort dose of INCB057643 monotherapy at the protocol specified starting dose in the TGA.
Treatment Group A included solid tumors and lymphoma
BG001
Part1/Treatment Group A : 12mg QD INCB057643
Initial cohort dose of INCB057643 monotherapy at the protocol specified starting dose in the TGA.
Treatment Group A included solid tumors and lymphoma
BG002
Part1/Treatment Group A : 16mg QD INCB057643
Initial cohort dose of INCB057643 monotherapy at the protocol specified starting dose in the TGA.
Treatment Group A included solid tumors and lymphoma
BG003
Part1/Treatment Group B : 8mg QD INCB057643
Initial cohort dose of INCB054763 monotherapy at the protocol-specified cohort escalation treatment group B (TGB), based on protocol-specific criteria. Treatment Group B included any acute leukemia, HRMDS, MDS/MPN, or MF
BG004
Part1/Treatment Group B : 12mg QD INCB057643
Initial cohort dose of INCB054763 monotherapy at the protocol-specified cohort escalation treatment group B (TGB), based on protocol-specific criteria. Treatment Group B included any acute leukemia, HRMDS, MDS/MPN, or MF.
BG005
Part1/Treatment Group C : 8mg QD INCB057643
Initial cohort dose of INCB054763 monotherapy at the protocol-specified cohort escalation treatment group C (TGC), based on protocol-specific criteria. Treatment Group C includes subjects with MM
BG006
Part2/Treatment Group A : 12 mg INCB057643 Expansion Cohort
Initial cohort dose of INCB054763 monotherapy at the specified RP2D dose selected in Part 1 cohort escalation treatment group A (TGA), based on protocol-specific criteria. Part 2 Treatment Group A expansion included pancreatic adenocarcinoma, castration-resistant prostrate cancer, breast cancer, high grade serious ovarian cancer, glioblastoma multiform, non-hodgkin's lymphoma, ewing's sarcoma, and solid tumor or lymphoma.
BG007
Part2/Treatment Group B : 12 mg INCB057643 Expansion Cohort
Initial cohort dose of INCB057463 monotherapy at the specified RP2D dose selected in Part 1 cohort escalation treatment group B (TGB), based on protocol-specific criteria. Part 2 Treatment Group B expansion included pancreatic adenocarcinoma, castration-resistant prostrate cancer, breast cancer, high grade serious ovarian cancer, glioblastoma multiform, non-hodgkin's lymphoma, ewing's sarcoma, and solid tumor or lymphoma.
BG008
Part3/Treatment Group A : 8 mg INCB057643 + Gemcitabine 1000mg
Initial cohort dose of INCB057643 monotherapy based on protocol-specific criteria. Part 3 will determine the MTD and/or a tolerated dose of the combination of INCB057643 and one of the SOC agents (Gemcitabine) in relapsed or refractory advanced or metastatic solid tumors and hematologic malignancies where Gemcitabine is relevant
BG009
Part3/Treatment Group B : 8 mg INCB057643 + Paclitaxel 80mg
Initial cohort dose of INCB054763 monotherapy based on protocol-specific criteria. Part 3 will determine the MTD and/or a tolerated dose of the combination of INCB057643 and one of the SOC agents (Paclitaxel) in relapsed or refractory advanced or metastatic solid tumors and hematologic malignancies.
BG010
Part3/Treatment Group C : 8 mg INCB057643 + Rucaparib 600mg
Initial cohort dose of INCB054763 monotherapy based on protocol-specific criteria. Part 3 will determine the MTD and/or a tolerated dose of the combination of INCB057643 and one of the SOC agents (Rucaparib) in relapsed or refractory advanced or metastatic solid tumors and hematologic malignancies.
BG011
Part3/Treatment Group D : 8 mg INCB057643 + Abir +Predni
Initial cohort dose of INCB054763 monotherapy based on protocol-specific criteria. Part 3 will determine the MTD and/or a tolerated dose of the combination of INCB057643 and one of the SOC agents (Abiraterone + Prednisone) in Castration Resistant Prostrate Cancer
BG012
Part3/Treatment Group E : 8 mg INCB057643 + Ruxolitinib 20mg
Initial cohort dose of INCB054763 monotherapy based on protocol-specific criteria. Part 3 will determine the MTD and/or a tolerated dose of the combination of INCB057643 and one of the SOC agents (Ruxolitinib) in Myelofibrosis.
BG013
Part3/Treatment Group F : 8 mg INCB057643 + Azacitidine 75mg
Initial cohort dose of INCB054763 monotherapy based on protocol-specific criteria. Part 3 will determine the MTD and/or a tolerated dose of the combination of INCB057643 and one of the SOC agents (Azacitidine) in Acute Myeloid Leukemia and Myelodysplastic Syndrome
BG014
Enrolled But Not Dosed
3 participants enrolled in the study and discontinued the study before study drug is administered
BG015
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG0004
BG0015
BG0028
BG0037
BG0045
BG0051
BG00686
BG0075
BG0081
BG0092
BG0104
BG0113
BG0121
BG0132
BG0143
BG015137
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
BG00064.3± 10.21
BG00160.2± 12.26
BG00260.5± 11.44
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0002
BG0012
BG002
Race/Ethnicity, Customized
Count of Participants
Participants
Title
Denominators
Categories
White/Caucasian
Title
Measurements
BG0003
BG0013
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Number of Participants With Treatment Emergent Adverse Events (TEAE's).
Adverse events reported for the first time or worsening of a pre-existing event after first dose of study drug/treatment.
All participants enrolled in the study who received at least 1 dose of study drug.
Posted
Number
Participants
From screening through at least 30 days after end of treatment, up to approximately 24 months
ID
Title
Description
OG000
Part1/Treatment Group A : 8mg QD INCB057643
Initial cohort dose of INCB057643 monotherapy at the protocol specified starting dose in the TGA.
Treatment Group A included solid tumors and lymphoma
OG001
Part1/Treatment Group A : 12mg QD INCB057643
Initial cohort dose of INCB057643 monotherapy at the protocol specified starting dose in the TGA.
Treatment Group A included solid tumors and lymphoma
OG002
Part1/Treatment Group A : 16mg QD INCB057643
Initial cohort dose of INCB057643 monotherapy at the protocol specified starting dose in the TGA.
Treatment Group A included solid tumors and lymphoma
OG003
Part1/Treatment Group B : 8mg QD INCB057643
Initial cohort dose of INCB054763 monotherapy at the protocol-specified cohort escalation treatment group B (TGB), based on protocol-specific criteria. Treatment Group B included any acute leukemia, HRMDS, MDS/MPN, or MF
OG004
Part1/Treatment Group B : 12mg QD INCB057643
Initial cohort dose of INCB054763 monotherapy at the protocol-specified cohort escalation treatment group B (TGB), based on protocol-specific criteria. Treatment Group B included any acute leukemia, HRMDS, MDS/MPN, or MF.
OG005
Part1/Treatment Group C : 8mg QD INCB057643
Initial cohort dose of INCB054763 monotherapy at the protocol-specified cohort escalation treatment group C (TGC), based on protocol-specific criteria. Treatment Group C includes subjects with MM
OG006
Part2/Treatment Group A : 12 mg INCB057643 Expansion Cohort
Initial cohort dose of INCB054763 monotherapy at the specified RP2D dose selected in Part 1 cohort escalation treatment group A (TGA), based on protocol-specific criteria. Part 2 Treatment Group A expansion included pancreatic adenocarcinoma, castration-resistant prostrate cancer, breast cancer, high grade serious ovarian cancer, glioblastoma multiform, non-hodgkin's lymphoma, ewing's sarcoma, and solid tumor or lymphoma.
OG007
Part2/Treatment Group B : 12 mg INCB057643 Expansion Cohort
Initial cohort dose of INCB057463 monotherapy at the specified RP2D dose selected in Part 1 cohort escalation treatment group B (TGB), based on protocol-specific criteria. Part 2 Treatment Group B expansion included pancreatic adenocarcinoma, castration-resistant prostrate cancer, breast cancer, high grade serious ovarian cancer, glioblastoma multiform, non-hodgkin's lymphoma, ewing's sarcoma, and solid tumor or lymphoma.
OG008
Part3/Treatment Group A : 8 mg INCB057643 + Gemcitabine 1000mg
Initial cohort dose of INCB057643 monotherapy based on protocol-specific criteria. Part 3 will determine the MTD and/or a tolerated dose of the combination of INCB057643 and one of the SOC agents (Gemcitabine) in relapsed or refractory advanced or metastatic solid tumors and hematologic malignancies where Gemcitabine is relevant
OG009
Part3/Treatment Group B : 8 mg INCB057643 + Paclitaxel 80mg
Initial cohort dose of INCB054763 monotherapy based on protocol-specific criteria. Part 3 will determine the MTD and/or a tolerated dose of the combination of INCB057643 and one of the SOC agents (Paclitaxel) in relapsed or refractory advanced or metastatic solid tumors and hematologic malignancies.
OG010
Part3/Treatment Group C : 8 mg INCB057643 + Rucaparib 600mg
Initial cohort dose of INCB054763 monotherapy based on protocol-specific criteria. Part 3 will determine the MTD and/or a tolerated dose of the combination of INCB057643 and one of the SOC agents (Rucaparib) in relapsed or refractory advanced or metastatic solid tumors and hematologic malignancies.
OG011
Part3/Treatment Group D : 8 mg INCB057643 + Abir +Predni
Initial cohort dose of INCB054763 monotherapy based on protocol-specific criteria. Part 3 will determine the MTD and/or a tolerated dose of the combination of INCB057643 and one of the SOC agents (Abiraterone + Prednisone) in Castration Resistant Prostrate Cancer
OG012
Part3/Treatment Group E : 8 mg INCB057643 + Ruxolitinib 20mg
Initial cohort dose of INCB054763 monotherapy based on protocol-specific criteria. Part 3 will determine the MTD and/or a tolerated dose of the combination of INCB057643 and one of the SOC agents (Ruxolitinib) in Myelofibrosis.
OG013
Part3/Treatment Group F : 8 mg INCB057643 + Azacitidine 75mg
Initial cohort dose of INCB054763 monotherapy based on protocol-specific criteria. Part 3 will determine the MTD and/or a tolerated dose of the combination of INCB057643 and one of the SOC agents (Azacitidine) in Acute Myeloid Leukemia and Myelodysplastic Syndrome
Units
Counts
Participants
OG0004
OG0015
OG0028
OG003
Title
Denominators
Categories
Title
Measurements
OG0004
OG0015
OG0028
OG003
Secondary
Percent Inhibition of Total Cellular Myc Protein Concentrations Before and After Administration of INCB057643 When Administered as Monotherapy in an Ex-vivo Assay
An ex vivo assay (utilized in monotherapy only), Measuring Total c-Myc protein expressed from an exogenously added cell line (KMS12BM) to patient plasma, before and after administration of INCB057643.
Posted
Mean
Standard Error
%Inhibition of Total c-Myc
PD in plasma at pre-dose and 0.5, 1, 2, 4, 6 and 8 hours postdose, for C1D1 and C1D8, and 24hrs post dose for C1D1
ID
Title
Description
OG000
8mg QD INCB057643
cohort dose of INCB057643 monotherapy at the protocol specified starting dose in the Part 1 TGA,TGB,TGC.
OG001
12mg QD INCB057643
12mg QD INCB057643 Initial cohort dose of INCB057643 monotherapy at the protocol specified starting dose in the Part 1 TGA,TGB, and Part 2 TGA,TGB.
OG002
16mg QD INCB057643
Initial cohort dose of INCB057643 monotherapy at the protocol specified starting dose in the Part 1 TGA
Units
Secondary
Objective Response Rate (ORR) With INCB057643 in Solid Tumors
Objective response rate is defined as the proportion of subjects who have an objective response using the applicable disease assessment criteria. ORR was proportion of participants with best overall response [complete response (CR) or partial response (PR)].
The efficacy evaluable population included all participants enrolled in the study who received at least 1 dose of study drug.
Posted
Number
Participants
Efficacy measures from screening through end of treatment and follow-up (every 9 weeks), up to approximately 24 months
ID
Title
Description
OG000
Part1/Treatment Group A : 8mg QD INCB057643
Initial cohort dose of INCB057643 monotherapy at the protocol specified starting dose in the TGA.
Treatment Group A included solid tumors and lymphoma
OG001
Part1/Treatment Group A : 12mg QD INCB057643
Initial cohort dose of INCB057643 monotherapy at the protocol specified starting dose in the TGA.
Treatment Group A included solid tumors and lymphoma
OG002
Part1/Treatment Group A : 16mg QD INCB057643
Initial cohort dose of INCB057643 monotherapy at the protocol specified starting dose in the TGA.
Treatment Group A included solid tumors and lymphoma
Secondary
Cmax: Maximum Observed Plasma Concentration of INCB057643.
Maximum Observed Plasma Concentration INCB057643 administered as monotherapy in fasted state.
PK evaluable population includes all subjects who received at least 1 dose of study drug and had at least 1 PK sample collected and analyzed
Posted
Mean
Standard Deviation
nM
Predose, 0.5, 1, 2, 4, 6, 8 hours on C1D1 and C1D8
ID
Title
Description
OG000
8mg QD INCB057643
Initial cohort dose of INCB057643 monotherapy at the protocol specified starting dose in the Part 1 TGA,TGB,TGC, and Part 2 TGA
OG001
12mg QD INCB057643
Initial cohort dose of INCB057643 monotherapy at the protocol specified starting dose in the Part 1 TGA,TGB, and Part 2 TGA,TGB.
OG002
16mg QD INCB057643
Initial cohort dose of INCB057643 monotherapy at the protocol specified starting dose in the Part 1 TGA
Units
Counts
Secondary
Tmax: Time to Maximum Plasma Concentration of INCB057643
Time to maximum plasma concentration of INCB057643 administered as monotherapy in fasted state
PK evaluable population includes all subjects who received at least 1 dose of study drug and had at least 1 PK sample collected and analyzed
Posted
Median
Full Range
hours
Predose, 0.5, 1, 2, 4, 6, 8 hours on C1D1 and C1D8
ID
Title
Description
OG000
8mg QD INCB057643
Initial cohort dose of INCB057643 monotherapy at the protocol specified starting dose in the Part 1 TGA,TGB,TGC, and Part 2 TGA
OG001
12mg QD INCB057643
Initial cohort dose of INCB057643 monotherapy at the protocol specified starting dose in the Part 1 TGA,TGB, and Part 2 TGA
OG002
16mg QD INCB057643
Initial cohort dose of INCB057643 monotherapy at the protocol specified starting dose in the Part 1 TGA
Units
Counts
Participants
Secondary
AUC0-t: Area Under the Single-dose Plasma Concentration-time Curve of INCB057643
Area under the single-dose plasma concentration-time curve from Hour 0 to the last quantifiable measurable plasma concentration of INCB057643 administered as monotherapy in fasted state
PK evaluable population includes all subjects who received at least 1 dose of study drug and had at least 1 PK sample collected and analyzed
Posted
Mean
Standard Deviation
h*nM
Predose, 0.5, 1, 2, 4, 6, 8 hours on C1D1
ID
Title
Description
OG000
8mg QD INCB057643
Initial cohort dose of INCB057643 monotherapy at the protocol specified starting dose in the Part 1 TGA,TGB,TGC, and Part 2 TGA
OG001
12mg QD INCB057643
Initial cohort dose of INCB057643 monotherapy at the protocol specified starting dose in the Part 1 TGA,TGB, and Part 2 TGA
OG002
16mg QD INCB057643
Initial cohort dose of INCB057643 monotherapy at the protocol specified starting dose in the Part 1 TGA
Secondary
AUC0-24: Area Under the Steady-state Plasma Concentration-time Curve of INCB057643 Administered as Monotherapy
Area under the steady-state plasma concentration-time curve over 1 dosing interval from Hour 0 to 24 for QD administration of INCB057643 administered as monotherapy in fasted state
PK evaluable population includes all subjects who received at least 1 dose of study drug and had at least 1 PK sample collected and analyzed
Posted
Mean
Standard Deviation
h*nM
Predose, 0.5, 1, 2, 4, 6, 8 hours on C1D8
ID
Title
Description
OG000
8mg QD INCB057643
Initial cohort dose of INCB057643 monotherapy at the protocol specified starting dose in the Part 1 TGA,TGB,TGC, and Part 2 TGA
OG001
12mg QD INCB057643
Initial cohort dose of INCB057643 monotherapy at the protocol specified starting dose in the Part 1 TGA,TGB, and Part 2 TGA
OG002
16mg QD INCB057643
Initial cohort dose of INCB057643 monotherapy at the protocol specified starting dose in the Part 1 TGA
Secondary
Part 2 - Cmax: Maximum Observed Plasma Concentration of INCB057643.
Maximum Observed Plasma Concentration INCB057643 administered as monotherapy in fed state.
PK evaluable population includes all subjects who received at least 1 dose of study drug and had at least 1 PK sample collected and analyzed
Posted
Mean
Standard Deviation
nM
C2D1
ID
Title
Description
OG000
12mg QD INCB057643
Initial cohort dose of INCB057643 monotherapy at the protocol specified starting dose in Part 2 TGA and TGB
Units
Counts
Participants
OG00011
Secondary
Part 2-Tmax: Time to Maximum Plasma Concentration of INCB057643
Time to maximum plasma concentration of INCB057643 administered as monotherapy in fed state
PK evaluable population includes all subjects who received at least 1 dose of study drug and had at least 1 PK sample collected and analyzed
Posted
Median
Full Range
hours
C2D1
ID
Title
Description
OG000
12mg QD INCB057643
Initial cohort dose of INCB057643 monotherapy at the protocol specified starting dose in Part 2 TGA and TGB
Units
Counts
Participants
OG00011
Secondary
AUC0-24: Area Under the Steady-state Plasma Concentration-time Curve of INCB057643 Administered as Monotherapy
Area under the steady-state plasma concentration-time curve over 1 dosing interval from Hour 0 to 24 for QD administration of INCB057643 administered as monotherapy in fed state.
PK evaluable population includes all subjects who received at least 1 dose of study drug and had at least 1 PK sample collected and analyzed
Posted
Mean
Standard Deviation
h*nM
C2D1
ID
Title
Description
OG000
12mg QD INCB057643
Initial cohort dose of INCB057643 monotherapy at the protocol specified starting dose in Part 2 TGA and TGB
Units
Counts
Participants
OG000
Time Frame
From screening through at least 30 days after end of treatment, up to approximately 24 months
Description
Not provided
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
Part1/Treatment Group A : 8mg QD INCB057643
Part1/Treatment Group A : 8mg QD INCB057643 Initial cohort dose of INCB057643 monotherapy at the protocol specified starting dose in the TGA.
Treatment Group A included solid tumors and lymphoma
2
4
2
4
4
4
EG001
Part1/Treatment Group A : 12mg QD INCB057643
Initial cohort dose of INCB057643 monotherapy at the protocol specified starting dose in the TGA.
Treatment Group A included solid tumors and lymphoma
4
5
1
5
5
5
EG002
Part1/Treatment Group A : 16mg QD INCB057643
Initial cohort dose of INCB057643 monotherapy at the protocol specified starting dose in the TGA.
Treatment Group A included solid tumors and lymphoma
5
8
4
8
7
8
EG003
Part1/Treatment Group B : 8mg QD INCB057643
Initial cohort dose of INCB054763 monotherapy at the protocol-specified cohort escalation treatment group B (TGB), based on protocol-specific criteria. Treatment Group B included any acute leukemia, HRMDS, MDS/MPN, or MF.
6
7
5
7
7
7
EG004
Part1/Treatment Group B : 12mg QD INCB057643
Initial cohort dose of INCB054763 monotherapy at the protocol-specified cohort escalation treatment group B (TGB), based on protocol-specific criteria. Treatment Group B included any acute leukemia, HRMDS, MDS/MPN, or MF.
4
5
4
5
5
5
EG005
Part1/Treatment Group C : 8mg QD INCB057643
Initial cohort dose of INCB054763 monotherapy at the protocol-specified cohort escalation treatment group C (TGC), based on protocol-specific criteria. Treatment Group C includes subjects with MM
1
1
1
1
0
1
EG006
Part2/Treatment Group A : 12 mg INCB057643 Expansion Cohort
Initial cohort dose of INCB054763 monotherapy at the specified RP2D dose selected in Part 1 cohort escalation treatment group A (TGA), based on protocol-specific criteria. Part 2 Treatment Group A expansion included pancreatic adenocarcinoma, castration-resistant prostrate cancer, breast cancer, high grade serious ovarian cancer, glioblastoma multiform, non-hodgkin's lymphoma, ewing's sarcoma, and solid tumor or lymphoma.
68
86
32
86
82
86
EG007
Part2/Treatment Group B : 12 mg INCB057643 Expansion Cohort
Initial cohort dose of INCB057463 monotherapy at the specified RP2D dose selected in Part 1 cohort escalation treatment group B (TGB), based on protocol-specific criteria. Part 2 Treatment Group B expansion included pancreatic adenocarcinoma, castration-resistant prostrate cancer, breast cancer, high grade serious ovarian cancer, glioblastoma multiform, non-hodgkin's lymphoma, ewing's sarcoma, and solid tumor or lymphoma.
3
5
4
5
5
5
EG008
Part3/Treatment Group A : 8 mg INCB057643 + Gemcitabine 1000mg
Initial cohort dose of INCB057643 monotherapy based on protocol-specific criteria. Part 3 will determine the MTD and/or a tolerated dose of the combination of INCB057643 and one of the SOC agents (Gemcitabine) in relapsed or refractory advanced or metastatic solid tumors and hematologic malignancies where Gemcitabine is relevant
0
1
0
1
1
1
EG009
Part3/Treatment Group B : 8 mg INCB057643 + Paclitaxel 80mg
Initial cohort dose of INCB054763 monotherapy based on protocol-specific criteria. Part 3 will determine the MTD and/or a tolerated dose of the combination of INCB057643 and one of the SOC agents (Paclitaxel) in relapsed or refractory advanced or metastatic solid tumors and hematologic malignancies.
1
2
0
2
2
2
EG010
Part3/Treatment Group C : 8 mg INCB057643 + Rucaparib 600mg
Initial cohort dose of INCB054763 monotherapy based on protocol-specific criteria. Part 3 will determine the MTD and/or a tolerated dose of the combination of INCB057643 and one of the SOC agents (Rucaparib) in relapsed or refractory advanced or metastatic solid tumors and hematologic malignancies.
1
4
0
4
4
4
EG011
Part3/Treatment Group D : 8 mg INCB057643 + Abir +Predni
Initial cohort dose of INCB054763 monotherapy based on protocol-specific criteria. Part 3 will determine the MTD and/or a tolerated dose of the combination of INCB057643 and one of the SOC agents (Abiraterone + Prednisone) in Castration Resistant Prostrate Cancer
1
3
1
3
3
3
EG012
Part3/Treatment Group E : 8 mg INCB057643 + Ruxolitinib 20mg
Initial cohort dose of INCB054763 monotherapy based on protocol-specific criteria. Part 3 will determine the MTD and/or a tolerated dose of the combination of INCB057643 and one of the SOC agents (Ruxolitinib) in Myelofibrosis.
0
1
1
1
1
1
EG013
Part3/Treatment Group F : 8 mg INCB057643 + Azacitidine 75mg
Initial cohort dose of INCB054763 monotherapy based on protocol-specific criteria. Part 3 will determine the MTD and/or a tolerated dose of the combination of INCB057643 and one of the SOC agents (Azacitidine) in Acute Myeloid Leukemia and Myelodysplastic Syndrome
0
2
0
2
2
2
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Abdominal pain
Gastrointestinal disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected8 at risk
EG0030 events0 affected7 at risk
EG0040 events0 affected5 at risk
EG0050 events0 affected1 at risk
EG0063 events3 affected86 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected1 at risk
EG0090 events0 affected2 at risk
EG0100 events0 affected4 at risk
EG0110 events0 affected3 at risk
EG0120 events0 affected1 at risk
EG0130 events0 affected2 at risk
Abdominal pain upper
Gastrointestinal disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0021 events1 affected8 at risk
EG003
Acute kidney injury
Renal and urinary disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected8 at risk
EG003
Acute myocardial infarction
Cardiac disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected8 at risk
EG003
Acute respiratory distress syndrome
Respiratory, thoracic and mediastinal disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected8 at risk
EG003
Acute respiratory failure
Respiratory, thoracic and mediastinal disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected8 at risk
EG003
Anaemia
Blood and lymphatic system disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected8 at risk
EG003
Appendicitis
Infections and infestations
MedDRA 19
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected8 at risk
EG003
Asthenia
General disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected8 at risk
EG003
Atrial fibrillation
Cardiac disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected8 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected8 at risk
EG003
Balance disorder
Nervous system disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected8 at risk
EG003
Bile duct obstruction
Hepatobiliary disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected8 at risk
EG003
Cardiac arrest
Cardiac disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected8 at risk
EG003
Cardiac failure congestive
Cardiac disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected8 at risk
EG003
Cardio-respiratory arrest
Cardiac disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected8 at risk
EG003
Confusional state
Psychiatric disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0021 events1 affected8 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected8 at risk
EG003
Cytomegalovirus oesophagitis
Infections and infestations
MedDRA 19
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected8 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected8 at risk
EG003
Deep vein thrombosis
Vascular disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected8 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected8 at risk
EG003
Delirium
Psychiatric disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected8 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected8 at risk
EG003
Disease progression
General disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected8 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected8 at risk
EG003
End stage renal disease
Renal and urinary disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected8 at risk
EG003
Failure to thrive
Metabolism and nutrition disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected8 at risk
EG003
Febrile neutropenia
Blood and lymphatic system disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected8 at risk
EG003
Gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected8 at risk
EG003
Haemoptysis
Respiratory, thoracic and mediastinal disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected8 at risk
EG003
Headache
Nervous system disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected8 at risk
EG003
Hepatic failure
Hepatobiliary disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected4 at risk
EG0011 events1 affected5 at risk
EG0020 events0 affected8 at risk
EG003
Herpes zoster
Infections and infestations
MedDRA 19
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected8 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected8 at risk
EG003
Hyperkalaemia
Metabolism and nutrition disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected8 at risk
EG003
Hypotension
Vascular disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected8 at risk
EG003
Hypoxia
Respiratory, thoracic and mediastinal disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected8 at risk
EG003
International normalised ratio increased
Investigations
MedDRA 19
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0021 events1 affected8 at risk
EG003
Intestinal obstruction
Gastrointestinal disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected8 at risk
EG003
Intestinal perforation
Gastrointestinal disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected8 at risk
EG003
Ischaemic stroke
Nervous system disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected8 at risk
EG003
Large intestinal obstruction
Gastrointestinal disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected8 at risk
EG003
Lung infection
Infections and infestations
MedDRA 19
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected8 at risk
EG003
Lung infiltration
Respiratory, thoracic and mediastinal disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected8 at risk
EG003
Muscular weakness
Musculoskeletal and connective tissue disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected8 at risk
EG003
Musculoskeletal pain
Musculoskeletal and connective tissue disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected8 at risk
EG003
Neck pain
Musculoskeletal and connective tissue disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected8 at risk
EG003
Nephrolithiasis
Renal and urinary disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0021 events1 affected8 at risk
EG003
Pain
General disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected8 at risk
EG003
Pancreatitis
Gastrointestinal disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected8 at risk
EG003
Performance status decreased
General disorders
MedDRA 19
Systematic Assessment
EG0001 events1 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected8 at risk
EG003
Periodontal disease
Gastrointestinal disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected8 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0021 events1 affected8 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 19
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0021 events1 affected8 at risk
EG003
Pneumonia bacterial
Infections and infestations
MedDRA 19
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected8 at risk
EG003
Pneumonia klebsiella
Infections and infestations
MedDRA 19
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected8 at risk
EG003
Pneumonia respiratory syncytial viral
Infections and infestations
MedDRA 19
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected8 at risk
EG003
Pneumonia streptococcal
Infections and infestations
MedDRA 19
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected8 at risk
EG003
Pneumothorax spontaneous
Respiratory, thoracic and mediastinal disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected8 at risk
EG003
Presyncope
Nervous system disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected8 at risk
EG003
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected8 at risk
EG003
Pulmonary oedema
Respiratory, thoracic and mediastinal disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected8 at risk
EG003
Respiratory failure
Respiratory, thoracic and mediastinal disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected8 at risk
EG003
Seizure
Nervous system disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected8 at risk
EG003
Sepsis
Infections and infestations
MedDRA 19
Systematic Assessment
EG0001 events1 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected8 at risk
EG003
Septic shock
Infections and infestations
MedDRA 19
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected8 at risk
EG003
Small intestinal obstruction
Gastrointestinal disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0021 events1 affected8 at risk
EG003
Spinal compression fracture
Injury, poisoning and procedural complications
MedDRA 19
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected8 at risk
EG003
Spinal cord infarction
Nervous system disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected8 at risk
EG003
Staphylococcal infection
Infections and infestations
MedDRA 19
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected8 at risk
EG003
Syncope
Nervous system disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0021 events1 affected8 at risk
EG003
Tachycardia
Cardiac disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected8 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected8 at risk
EG003
Tumour pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 19
Systematic Assessment
EG0002 events1 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected8 at risk
EG003
Upper gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected8 at risk
EG003
Urinary retention
Renal and urinary disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected8 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 19
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected8 at risk
EG003
Urosepsis
Infections and infestations
MedDRA 19
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected8 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Abdominal distension
Gastrointestinal disorders
MedDRA 19
Systematic Assessment
EG0001 events1 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected8 at risk
EG0030 events0 affected7 at risk
EG0040 events0 affected5 at risk
EG0050 events0 affected1 at risk
EG0061 events1 affected86 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected1 at risk
EG0090 events0 affected2 at risk
EG0100 events0 affected4 at risk
EG0110 events0 affected3 at risk
EG0120 events0 affected1 at risk
EG0130 events0 affected2 at risk
Abdominal pain
Gastrointestinal disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected4 at risk
EG0012 events2 affected5 at risk
EG0022 events2 affected8 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected8 at risk
EG003
Acne
Skin and subcutaneous tissue disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected8 at risk
EG003
Activated partial thromboplastin time prolonged
Investigations
MedDRA 19
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected8 at risk
EG003
Acute kidney injury
Renal and urinary disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0021 events1 affected8 at risk
EG003
Acute sinusitis
Infections and infestations
MedDRA 19
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected8 at risk
EG003
Agitation
Psychiatric disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected8 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA 19
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0021 events1 affected8 at risk
EG003
Alopecia
Skin and subcutaneous tissue disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected8 at risk
EG003
Anaemia
Blood and lymphatic system disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected4 at risk
EG0012 events1 affected5 at risk
EG0023 events3 affected8 at risk
EG003
Anal fissure
Gastrointestinal disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected8 at risk
EG003
Angioedema
Skin and subcutaneous tissue disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected8 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA 19
Systematic Assessment
EG0001 events1 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected8 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected8 at risk
EG003
Arthropod bite
Injury, poisoning and procedural complications
MedDRA 19
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected8 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA 19
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0021 events1 affected8 at risk
EG003
Asthenia
General disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0021 events1 affected8 at risk
EG003
Atrial fibrillation
Cardiac disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected8 at risk
EG003
Atrioventricular block second degree
Cardiac disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected8 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 19
Systematic Assessment
EG0001 events1 affected4 at risk
EG0011 events1 affected5 at risk
EG0021 events1 affected8 at risk
EG003
Basal cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 19
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected8 at risk
EG003
Benign neoplasm
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 19
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected8 at risk
EG003
Bilirubin conjugated increased
Investigations
MedDRA 19
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0021 events1 affected8 at risk
EG003
Blood alkaline phosphatase increased
Investigations
MedDRA 19
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected8 at risk
EG003
Blood bilirubin increased
Investigations
MedDRA 19
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0023 events1 affected8 at risk
EG003
Blood creatinine increased
Investigations
MedDRA 19
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected8 at risk
EG003
Blood pressure increased
Investigations
MedDRA 19
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected8 at risk
EG003
Brain oedema
Nervous system disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected8 at risk
EG003
Bronchitis
Infections and infestations
MedDRA 19
Systematic Assessment
EG0002 events1 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected8 at risk
EG003
Cataract
Eye disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0021 events1 affected8 at risk
EG003
Catheter site erythema
General disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0021 events1 affected8 at risk
EG003
Catheter site haemorrhage
General disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected8 at risk
EG003
Catheter site pain
General disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected8 at risk
EG003
Chancroid
Infections and infestations
MedDRA 19
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected8 at risk
EG003
Chills
General disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0021 events1 affected8 at risk
EG003
Chronic obstructive pulmonary disease
Respiratory, thoracic and mediastinal disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected8 at risk
EG003
Conjunctivitis
Infections and infestations
MedDRA 19
Systematic Assessment
EG0001 events1 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected8 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected4 at risk
EG0012 events2 affected5 at risk
EG0021 events1 affected8 at risk
EG003
Contusion
Injury, poisoning and procedural complications
MedDRA 19
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0021 events1 affected8 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 19
Systematic Assessment
EG0001 events1 affected4 at risk
EG0011 events1 affected5 at risk
EG0020 events0 affected8 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA 19
Systematic Assessment
EG0002 events2 affected4 at risk
EG0012 events2 affected5 at risk
EG0023 events3 affected8 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected8 at risk
EG003
Depression
Psychiatric disorders
MedDRA 19
Systematic Assessment
EG0002 events2 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected8 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 19
Systematic Assessment
EG0001 events1 affected4 at risk
EG0012 events2 affected5 at risk
EG0023 events3 affected8 at risk
EG003
Dizziness
Nervous system disorders
MedDRA 19
Systematic Assessment
EG0001 events1 affected4 at risk
EG0011 events1 affected5 at risk
EG0021 events1 affected8 at risk
EG003
Drug withdrawal syndrome
General disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected4 at risk
EG0011 events1 affected5 at risk
EG0020 events0 affected8 at risk
EG003
Dry mouth
Gastrointestinal disorders
MedDRA 19
Systematic Assessment
EG0001 events1 affected4 at risk
EG0011 events1 affected5 at risk
EG0021 events1 affected8 at risk
EG003
Dry skin
Skin and subcutaneous tissue disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected8 at risk
EG003
Dysgeusia
Nervous system disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected4 at risk
EG0011 events1 affected5 at risk
EG0022 events2 affected8 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0021 events1 affected8 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected4 at risk
EG0011 events1 affected5 at risk
EG0020 events0 affected8 at risk
EG003
Dyspnoea exertional
Respiratory, thoracic and mediastinal disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected8 at risk
EG003
Dysuria
Renal and urinary disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected8 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected8 at risk
EG003
Erythema
Skin and subcutaneous tissue disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected8 at risk
EG003
Eye contusion
Injury, poisoning and procedural complications
MedDRA 19
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected8 at risk
EG003
Eye pain
Eye disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0021 events1 affected8 at risk
EG003
Eyelid oedema
Eye disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected8 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA 19
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0021 events1 affected8 at risk
EG003
Fatigue
General disorders
MedDRA 19
Systematic Assessment
EG0002 events2 affected4 at risk
EG0014 events4 affected5 at risk
EG0024 events4 affected8 at risk
EG003
Febrile neutropenia
Blood and lymphatic system disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected8 at risk
EG003
Flank pain
Musculoskeletal and connective tissue disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected8 at risk
EG003
Flatulence
Gastrointestinal disorders
MedDRA 19
Systematic Assessment
EG0001 events1 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected8 at risk
EG003
Fractured sacrum
Injury, poisoning and procedural complications
MedDRA 19
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected8 at risk
EG003
Fungal infection
Infections and infestations
MedDRA 19
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected8 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA 19
Systematic Assessment
EG0001 events1 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected8 at risk
EG003
Gingivitis
Infections and infestations
MedDRA 19
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected8 at risk
EG003
Groin infection
Infections and infestations
MedDRA 19
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0021 events1 affected8 at risk
EG003
Haematoma
Vascular disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0021 events1 affected8 at risk
EG003
Haematuria
Renal and urinary disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected8 at risk
EG003
Haemoptysis
Respiratory, thoracic and mediastinal disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected8 at risk
EG003
Haemorrhoids
Gastrointestinal disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected8 at risk
EG003
Headache
Nervous system disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0023 events1 affected8 at risk
EG003
Herpes simplex
Infections and infestations
MedDRA 19
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected8 at risk
EG003
Herpes zoster
Infections and infestations
MedDRA 19
Systematic Assessment
EG0001 events1 affected4 at risk
EG0010 events0 affected5 at risk
EG0021 events1 affected8 at risk
EG003
Hot flush
Vascular disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0021 events1 affected8 at risk
EG003
Hyperbilirubinaemia
Hepatobiliary disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected8 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA 19
Systematic Assessment
EG0002 events2 affected4 at risk
EG0010 events0 affected5 at risk
EG0026 events3 affected8 at risk
EG003
Hypertension
Vascular disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected4 at risk
EG0011 events1 affected5 at risk
EG0022 events2 affected8 at risk
EG003
Hypertriglyceridaemia
Metabolism and nutrition disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected8 at risk
EG003
Hypoalbuminaemia
Metabolism and nutrition disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected8 at risk
EG003
Hypocalcaemia
Metabolism and nutrition disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected8 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected4 at risk
EG0011 events1 affected5 at risk
EG0020 events0 affected8 at risk
EG003
Hypomagnesaemia
Metabolism and nutrition disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected8 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0021 events1 affected8 at risk
EG003
Hypophosphataemia
Metabolism and nutrition disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0021 events1 affected8 at risk
EG003
Hypotension
Vascular disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected8 at risk
EG003
Hypoxia
Respiratory, thoracic and mediastinal disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0021 events1 affected8 at risk
EG003
Increased tendency to bruise
Blood and lymphatic system disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected8 at risk
EG003
Influenza like illness
General disorders
MedDRA 19
Systematic Assessment
EG0001 events1 affected4 at risk
EG0010 events0 affected5 at risk
EG0021 events1 affected8 at risk
EG003
Infusion related reaction
Injury, poisoning and procedural complications
MedDRA 19
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected8 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected8 at risk
EG003
International normalised ratio increased
Investigations
MedDRA 19
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0021 events1 affected8 at risk
EG003
Iron deficiency anaemia
Blood and lymphatic system disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0021 events1 affected8 at risk
EG003
Laceration
Injury, poisoning and procedural complications
MedDRA 19
Systematic Assessment
EG0001 events1 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected8 at risk
EG003
Leukocytosis
Blood and lymphatic system disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected8 at risk
EG003
Leukopenia
Blood and lymphatic system disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected8 at risk
EG003
Lip haemorrhage
Gastrointestinal disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected8 at risk
EG003
Localised oedema
General disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected8 at risk
EG003
Lower respiratory tract infection bacterial
Infections and infestations
MedDRA 19
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected8 at risk
EG003
Lung infection
Infections and infestations
MedDRA 19
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected8 at risk
EG003
Lymph gland infection
Infections and infestations
MedDRA 19
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected8 at risk
EG003
Lymph node pain
Blood and lymphatic system disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected8 at risk
EG003
Lymphopenia
Blood and lymphatic system disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected8 at risk
EG003
Metabolic acidosis
Metabolism and nutrition disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected8 at risk
EG003
Mucosal dryness
General disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected8 at risk
EG003
Mucosal haemorrhage
General disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected8 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA 19
Systematic Assessment
EG0002 events1 affected4 at risk
EG0010 events0 affected5 at risk
EG0021 events1 affected8 at risk
EG003
Muscular weakness
Musculoskeletal and connective tissue disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected8 at risk
EG003
Musculoskeletal pain
Musculoskeletal and connective tissue disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected8 at risk
EG003
Nasal congestion
Respiratory, thoracic and mediastinal disorders
MedDRA 19
Systematic Assessment
EG0001 events1 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected8 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 19
Systematic Assessment
EG0005 events3 affected4 at risk
EG0014 events4 affected5 at risk
EG0026 events4 affected8 at risk
EG003
Neck pain
Musculoskeletal and connective tissue disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected8 at risk
EG003
Neuropathy peripheral
Nervous system disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected8 at risk
EG003
Neutropenia
Blood and lymphatic system disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected8 at risk
EG003
Neutrophil count decreased
Investigations
MedDRA 19
Systematic Assessment
EG0000 events0 affected4 at risk
EG0012 events1 affected5 at risk
EG0020 events0 affected8 at risk
EG003
Non-cardiac chest pain
General disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected8 at risk
EG003
Oedema peripheral
General disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected8 at risk
EG003
Oesophageal haemorrhage
Gastrointestinal disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected8 at risk
EG003
Oral candidiasis
Infections and infestations
MedDRA 19
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected8 at risk
EG003
Oral pain
Gastrointestinal disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected8 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected8 at risk
EG003
Pain in jaw
Musculoskeletal and connective tissue disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected8 at risk
EG003
Pain of skin
Skin and subcutaneous tissue disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected8 at risk
EG003
Penile oedema
Reproductive system and breast disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected8 at risk
EG003
Performance status decreased
General disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0021 events1 affected8 at risk
EG003
Petechiae
Skin and subcutaneous tissue disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected8 at risk
EG003
Platelet count decreased
Investigations
MedDRA 19
Systematic Assessment
EG0001 events1 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected8 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected8 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 19
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected8 at risk
EG003
Pneumonitis
Respiratory, thoracic and mediastinal disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected8 at risk
EG003
Post herpetic neuralgia
Nervous system disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected8 at risk
EG003
Productive cough
Respiratory, thoracic and mediastinal disorders
MedDRA 19
Systematic Assessment
EG0001 events1 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected8 at risk
EG003
Prothrombin time prolonged
Investigations
MedDRA 19
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected8 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA 19
Systematic Assessment
EG0001 events1 affected4 at risk
EG0011 events1 affected5 at risk
EG0021 events1 affected8 at risk
EG003
Pulmonary oedema
Respiratory, thoracic and mediastinal disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected8 at risk
EG003
Purpura
Skin and subcutaneous tissue disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected8 at risk
EG003
Pyrexia
General disorders
MedDRA 19
Systematic Assessment
EG0002 events1 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected8 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0021 events1 affected8 at risk
EG003
Respiratory failure
Respiratory, thoracic and mediastinal disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected8 at risk
EG003
Retinal haemorrhage
Eye disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected8 at risk
EG003
Rotator cuff syndrome
Musculoskeletal and connective tissue disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected8 at risk
EG003
Scab
Skin and subcutaneous tissue disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected8 at risk
EG003
Sinus bradycardia
Cardiac disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected8 at risk
EG003
Sinus tachycardia
Cardiac disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected8 at risk
EG003
Sinusitis
Infections and infestations
MedDRA 19
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected8 at risk
EG003
Skin infection
Infections and infestations
MedDRA 19
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected8 at risk
EG003
Skin ulcer
Skin and subcutaneous tissue disorders
MedDRA 19
Systematic Assessment
EG0001 events1 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected8 at risk
EG003
Sneezing
Respiratory, thoracic and mediastinal disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0021 events1 affected8 at risk
EG003
Splenic infarction
Blood and lymphatic system disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected8 at risk
EG003
Splenomegaly
Blood and lymphatic system disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected8 at risk
EG003
Squamous cell carcinoma of skin
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Female Urogenital Diseases and Pregnancy Complications
D005833
Genital Neoplasms, Female
D006058
Gonadal Disorders
D001254
Astrocytoma
D005910
Glioma
D018302
Neoplasms, Neuroepithelial
D017599
Neuroectodermal Tumors
D009373
Neoplasms, Germ Cell and Embryonal
D009375
Neoplasms, Glandular and Epithelial
D009380
Neoplasms, Nerve Tissue
D016393
Lymphoma, B-Cell
Browse Leaves
Not provided
Browse Branches
Not provided
ID
Term
C000712522
INCB057643
D000093542
Gemcitabine
D017239
Paclitaxel
C531549
rucaparib
C089740
abiraterone
C540383
ruxolitinib
D001374
Azacitidine
Ancestor Terms
ID
Term
D006571
Heterocyclic Compounds
D003841
Deoxycytidine
D003562
Cytidine
D011741
Pyrimidine Nucleosides
D011743
Pyrimidines
D006573
Heterocyclic Compounds, 1-Ring
D043823
Taxoids
D043822
Cyclodecanes
D003516
Cycloparaffins
D006840
Hydrocarbons, Alicyclic
D006844
Hydrocarbons, Cyclic
D006838
Hydrocarbons
D009930
Organic Chemicals
D004224
Diterpenes
D013729
Terpenes
D001372
Aza Compounds
D009705
Nucleosides
D009706
Nucleic Acids, Nucleotides, and Nucleosides
D012263
Ribonucleosides
Browse Leaves
Not provided
Browse Branches
Not provided
0 subjects
FG0050 subjects
FG0061 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
1 subjects
FG0050 subjects
FG00612 subjects
FG0072 subjects
FG0081 subjects
FG0091 subjects
FG0103 subjects
FG0112 subjects
FG0121 subjects
FG0131 subjects
FG0142 subjects
0 subjects
FG0050 subjects
FG0063 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0141 subjects
1 subjects
FG0050 subjects
FG0067 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0131 subjects
FG0140 subjects
0 subjects
FG0050 subjects
FG0062 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
68.9
± 5.81
BG00475.8± 7.33
BG00570.0± NASD is not calculable as there is only 1 participant enrolled in this arm.
BG00660.6± 13.80
BG00772.6± 10.92
BG00872.0± 0
BG00956.0± 12.73
BG01066.0± 6.16
BG01167.7± 4.04
BG01275.0± 0
BG01376.5± 2.12
BG01466.0± 6.24
BG01563.0± 12.80
5
BG0033
BG0041
BG0050
BG00648
BG0070
BG0081
BG0091
BG0104
BG0110
BG0120
BG0130
BG0141
BG01568
Male
BG0002
BG0013
BG0023
BG0034
BG0044
BG0051
BG00638
BG0075
BG0080
BG0091
BG0100
BG0113
BG0121
BG0132
BG0142
BG01569
5
BG0036
BG0044
BG0050
BG00671
BG0075
BG0080
BG0091
BG0104
BG0113
BG0121
BG0132
BG0143
BG015111
Black/African American
Title
Measurements
BG0001
BG0010
BG0022
BG0031
BG0040
BG0050
BG00610
BG0070
BG0081
BG0091
BG0100
BG0110
BG0120
BG0130
BG0140
BG01516
Asian
Title
Measurements
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
BG0070
BG0080
BG0090
BG0100
BG0110
BG0120
BG0130
BG0140
BG0150
American-Indian/Alaska Native
Title
Measurements
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0061
BG0070
BG0080
BG0090
BG0100
BG0110
BG0120
BG0130
BG0140
BG0151
Native Hawaiian/Pacific Islander
Title
Measurements
BG0000
BG0011
BG0020
BG0030
BG0040
BG0050
BG0060
BG0070
BG0080
BG0090
BG0100
BG0110
BG0120
BG0130
BG0140
BG0151
Other
Title
Measurements
BG0000
BG0011
BG0021
BG0030
BG0041
BG0051
BG0062
BG0070
BG0080
BG0090
BG0100
BG0110
BG0120
BG0130
BG0140
BG0156
Missing
Title
Measurements
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0061
BG0070
BG0080
BG0090
BG0100
BG0110
BG0120
BG0130
BG0140
BG0151
7
OG0045
OG0051
OG00686
OG0075
OG0081
OG0092
OG0104
OG0113
OG0121
OG0132
7
OG0045
OG0051
OG00686
OG0075
OG0081
OG0092
OG0104
OG0113
OG0121
OG0132
Counts
Participants
OG00011
OG00151
OG0027
Title
Denominators
Categories
C1D1
Title
Measurements
OG00024± 199.5
OG00128± 200.1
OG00254± 236.3
C1D8
Title
Measurements
OG00030± 42.59
OG00143.4± 52.7
OG00265± 55.21
OG003
Part1/Treatment Group B : 8mg QD INCB057643
Initial cohort dose of INCB054763 monotherapy at the protocol-specified cohort escalation treatment group B (TGB), based on protocol-specific criteria. Treatment Group B included any acute leukemia, HRMDS, MDS/MPN, or MF
OG004
Part1/Treatment Group B : 12mg QD INCB057643
Initial cohort dose of INCB054763 monotherapy at the protocol-specified cohort escalation treatment group B (TGB), based on protocol-specific criteria. Treatment Group B included any acute leukemia, HRMDS, MDS/MPN, or MF.
OG005
Part1/Treatment Group C : 8mg QD INCB057643
Initial cohort dose of INCB054763 monotherapy at the protocol-specified cohort escalation treatment group C (TGC), based on protocol-specific criteria. Treatment Group C includes subjects with MM
OG006
Part2/Treatment Group A : 12 mg INCB057643 Expansion Cohort
Initial cohort dose of INCB054763 monotherapy at the specified RP2D dose selected in Part 1 cohort escalation treatment group A (TGA), based on protocol-specific criteria. Part 2 Treatment Group A expansion included pancreatic adenocarcinoma, castration-resistant prostrate cancer, breast cancer, high grade serious ovarian cancer, glioblastoma multiform, non-hodgkin's lymphoma, ewing's sarcoma, and solid tumor or lymphoma.
OG007
Part2/Treatment Group B : 12 mg INCB057643 Expansion Cohort
Initial cohort dose of INCB057463 monotherapy at the specified RP2D dose selected in Part 1 cohort escalation treatment group B (TGB), based on protocol-specific criteria. Part 2 Treatment Group B expansion included pancreatic adenocarcinoma, castration-resistant prostrate cancer, breast cancer, high grade serious ovarian cancer, glioblastoma multiform, non-hodgkin's lymphoma, ewing's sarcoma, and solid tumor or lymphoma.
OG008
Part3/Treatment Group A : 8 mg INCB057643 + Gemcitabine 1000mg
Initial cohort dose of INCB057643 monotherapy based on protocol-specific criteria. Part 3 will determine the MTD and/or a tolerated dose of the combination of INCB057643 and one of the SOC agents (Gemcitabine) in relapsed or refractory advanced or metastatic solid tumors and hematologic malignancies where Gemcitabine is relevant
OG009
Part3/Treatment Group B : 8 mg INCB057643 + Paclitaxel 80mg
Initial cohort dose of INCB054763 monotherapy based on protocol-specific criteria. Part 3 will determine the MTD and/or a tolerated dose of the combination of INCB057643 and one of the SOC agents (Paclitaxel) in relapsed or refractory advanced or metastatic solid tumors and hematologic malignancies.
OG010
Part3/Treatment Group C : 8 mg INCB057643 + Rucaparib 600mg
Initial cohort dose of INCB054763 monotherapy based on protocol-specific criteria. Part 3 will determine the MTD and/or a tolerated dose of the combination of INCB057643 and one of the SOC agents (Rucaparib) in relapsed or refractory advanced or metastatic solid tumors and hematologic malignancies.
OG011
Part3/Treatment Group D : 8 mg INCB057643 + Abir +Predni
Initial cohort dose of INCB054763 monotherapy based on protocol-specific criteria. Part 3 will determine the MTD and/or a tolerated dose of the combination of INCB057643 and one of the SOC agents (Abiraterone + Prednisone) in Castration Resistant Prostrate Cancer
OG012
Part3/Treatment Group E : 8 mg INCB057643 + Ruxolitinib 20mg
Initial cohort dose of INCB054763 monotherapy based on protocol-specific criteria. Part 3 will determine the MTD and/or a tolerated dose of the combination of INCB057643 and one of the SOC agents (Ruxolitinib) in Myelofibrosis.
OG013
Part3/Treatment Group F : 8 mg INCB057643 + Azacitidine 75mg
Initial cohort dose of INCB054763 monotherapy based on protocol-specific criteria. Part 3 will determine the MTD and/or a tolerated dose of the combination of INCB057643 and one of the SOC agents (Azacitidine) in Acute Myeloid Leukemia and Myelodysplastic Syndrome