A Study of Rebastinib (DCC-2036) in Combination With Carb... | NCT03717415 | Trialant
NCT03717415
Sponsor
Deciphera Pharmaceuticals, LLC
Status
Terminated
Last Update Posted
Dec 27, 2024Actual
Enrollment
70Actual
Phase
Phase 1Phase 2
Conditions
Locally Advanced or Metastatic Solid Tumor
Interventions
Rebastinib
Carboplatin
Countries
United States
Protocol Section
Identification Module
NCT ID
NCT03717415
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
DCC-2036-01-004
Secondary IDs
Not provided
Brief Title
A Study of Rebastinib (DCC-2036) in Combination With Carboplatin in Patients With Advanced or Metastatic Solid Tumors
Official Title
An Open Label, Multicenter, Phase 1b/2 Study of Rebastinib (DCC-2036) in Combination With Carboplatin to Assess Safety, Tolerability, and Pharmacokinetics in Patients With Advanced or Metastatic Solid Tumors
Acronym
Not provided
Organization
Deciphera Pharmaceuticals, LLCINDUSTRY
Status Module
Record Verification Date
Dec 2024
Overall Recruitment Status or Expanded Access Status
Terminated
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Development program terminated.
Expanded Access Info
Not provided
Start Date
Jan 2, 2019Actual
Primary Completion Date
May 1, 2022Actual
Completion Date
Nov 1, 2022Actual
First Submitted Date
Oct 19, 2018
First Submission Date that Met QC Criteria
Oct 22, 2018
First Posted Date
Oct 24, 2018Actual
Results Waived
Not provided
Results First Submitted Date
Dec 3, 2024
Results First Submitted that Met QC Criteria
Dec 3, 2024
Results First Posted Date
Dec 27, 2024Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Dec 3, 2024
Last Update Posted Date
Dec 27, 2024Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Deciphera Pharmaceuticals, LLCINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
Not provided
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
This is an open-label Phase 1b/2 multicenter study of rebastinib (DCC-2036) in combination with carboplatin designed to evaluate the safety, tolerability, and pharmacokinetics (PK) in participants with advanced or metastatic solid tumors.
Dose escalation with rebastinib 50 milligram (mg) twice daily (BID) orally (PO) in 21-day cycles in combination with carboplatin administered by intravenous (IV) infusion at area under the curve (AUC)5 at Day 1 of each 21-day cycle.
Dose escalation with rebastinib 100 mg BID PO in 21-day cycles in combination with carboplatin administered by IV infusion at AUC5 at Day 1 of each 21-day cycle.
Dose escalation with rebastinib 100 mg BID PO in 21-day cycles in combination with carboplatin administered by IV infusion at AUC6 at Day 1 of each 21-day cycle.
Dose expansion in triple-negative breast cancer (TNBC) participants. Rebastinib 50 mg BID PO in 21-day cycles in combination with carboplatin administered by IV infusion at AUC5 at Day 1 of each 21-day cycle.
Percentage of participants who achieved an objective response of Complete Response (CR) or Partial Response (PR) per Response Evaluation Criteria in Solid Tumor (RECIST) v1.1. CR is defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) had to have reduction in short axis to <10 mm. PR is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Disease progression is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study including baseline; or the appearance of one or more new lesions.
Time from CR or PR to disease progression or death due to any cause (Up to 1.53 years)
Percentage of participants who achieved an objective response of Complete Response (CR) or Partial Response (PR) per Response Evaluation Criteria in Solid Tumor (RECIST) v1.1. CR is defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) had to have reduction in short axis to <10 mm. PR is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Disease progression is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study including baseline; or the appearance of one or more new lesions.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Male or female patients ≥18 years of age at the time of informed consent.
Part 1 (Dose Escalation). Histologically confirmed diagnosis of a locally advanced or metastatic solid tumor for which carboplatin is considered appropriate treatment.
Part 2 (Dose Expansion)
Previously treated, triple-negative breast cancer.
Recurrent platinum-sensitive ovarian cancer.
Histologically confirmed pleural or peritoneal malignant mesothelioma.
ECOG performance status of ≤2.
Able to provide an archival tumor tissue sample.
Adequate organ function and bone marrow reserve.
If a female of childbearing potential, must have a negative pregnancy test prior to enrollment.
Patient must provide signed consent to participate in the study and is willing to comply with study-specific procedures.
Exclusion Criteria:
Received prior anticancer or other investigational therapy within 28 days or 5× the half-life (whichever is shorter) prior to the first dose.
Not recovered from prior-treatment toxicities to Grade ≤1 or baseline.
Peripheral neuropathy of any etiology >Grade 1.
Concurrent malignancy.
Known active CNS metastases.
Use of systemic corticosteroids.
Known retinal neovascularization, macular edema or macular degeneration.
History or presence of clinically relevant cardiovascular abnormalities.
QTcF >450 ms in males or >470 ms in females.
Left ventricular ejection fraction (LVEF) <50% at screening.
Arterial thrombotic or embolic events.
Symptomatic venous thrombotic event.
Active infection ≥Grade 3.
Known HIV or HCV infection only if taking medications excluded per protocol, active HBV, or active HCV infection.
Use of proton pump inhibitors.
If female, the patient is pregnant or lactating.
Major surgery 4 weeks prior to the first dose of study drug.
Malabsorption syndrome or other illness which could affect oral absorption.
Known allergy or hypersensitivity to any component of rebastinib or any of its excipients.
Dose escalation with rebastinib 50 milligram (mg) twice daily (BID) orally (PO) in 21-day cycles in combination with carboplatin administered by intravenous (IV) infusion at area under the curve (AUC)5 at Day 1 of each 21-day cycle.
FG001
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
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Not provided
Uploaded Document Information
Type
Includes Protocol
Includes SAP
Includes ICF
Document Label
Document Date
Document Uploaded Date
Document File Name
Prot
Yes
No
No
Study Protocol
Feb 24, 2020
Dec 2, 2024
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
Randomized
Intervention Model
Sequential Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
None (Open Label)
Masking Description
Not provided
Who Masked
Not provided
Experimental
Dose expansion in TNBC participants. Rebastinib 100 mg BID PO in 21-day cycles in combination with carboplatin administered by IV infusion at AUC5 at Day 1 of each 21-day cycle.
Dose expansion in platinum-sensitive ovarian cancer participants. Rebastinib 50 mg BID PO in 21-day cycles in combination with carboplatin administered by IV infusion at AUC5 at Day 1 of each 21-day cycle.
Dose expansion in platinum-sensitive ovarian cancer participants. Rebastinib 100 mg BID PO in 21-day cycles in combination with carboplatin administered by IV infusion at AUC5 at Day 1 of each 21-day cycle.
Dose expansion in mesothelioma participants. Rebastinib 50 mg BID PO in 21-day cycles in combination with carboplatin administered by IV infusion at AUC5 at Day 1 of each 21-day cycle.
Dose expansion in mesothelioma participants. Rebastinib 100 mg BID PO in 21-day cycles in combination with carboplatin administered by IV infusion at AUC5 at Day 1 of each 21-day cycle.
Time from CR or PR to disease progression or death due to any cause (Up to 1.53 years)
Duration of Response (DOR)
Time from first partial response (PR) or complete response (CR) to disease progression (PD) or death due to any cause. Evaluation of radiographic disease assessment per Response Evaluation Criteria in Solid Tumor (RECIST v1.1). CR is defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) had to have reduction in short axis to <10 mm. PR is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Disease progression is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study including baseline; or the appearance of one or more new lesions.
Time from PR or CR to PD or Death due to Any Cause (up to 1.53 years)
Time to Progression (TTP)
Time from first dose of study drug to the first documentation of progressive disease (PD). Participants were considered to have progressive disease if they had documented progression based on radiologic assessment according to RECIST v1.1. RECIST v1.1 defined disease progression as at least a 20% increase in the sum of the disease measurements for measurable lesions, taking as reference the smallest disease measurement recorded since the start of treatment, or the appearance of one or more new lesions.
First Dose of Study Drug to PD (Up to 1.63 years)
Progression-free-survival (PFS)
Time from first dose of study drug to disease progression (PD) or death due to any cause. Participants who undergo surgical resection of target or non-target lesions, who have received other anticancer treatments, including surgical resection or radiation (other than palliative radiation to pre-existing bone metastases'), or who do not have a documented date of progression or death due to any cause will be censored at the date of the last assessment. Disease progression per RECIST v1.1 is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study including baseline; or the appearance of one or more new lesions.
First Dose of Study Drug to PD or Death due to Any Cause (up to 1.63 years)
Overall Survival (OS)
Time from baseline C1 D1 to date of death due to any cause. Participants who are still alive or who are lost to follow-up will be censored at the date of last contact.
Baseline to death due to any cause (Up to 2.12 years)
Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of Rebastinib (Part 1)
Cmax of rebastinib
Part 1: Cycle (C) 1 Day (D) 1, C2 D1 (Cycle = 21 Days)
PK: Area Under the Concentration-time Curve 0-3 Hours (AUC 0-3 Hours) (Part 1)
Measure the AUC 0-3 hours
Part 1: Cycle (C) 1 Day (D) 1, C2 D1 (Cycle = 21 Days)
Dose escalation with rebastinib 100 mg BID PO in 21-day cycles in combination with carboplatin administered by IV infusion at AUC5 at Day 1 of each 21-day cycle.
Dose escalation with rebastinib 100 mg BID PO in 21-day cycles in combination with carboplatin administered by IV infusion at AUC6 at Day 1 of each 21-day cycle.
Dose expansion in triple-negative breast cancer (TNBC) participants. Rebastinib 50 mg BID PO in 21-day cycles in combination with carboplatin administered by IV infusion at AUC5 at Day 1 of each 21-day cycle.
Dose expansion in TNBC participants. Rebastinib 100 mg BID PO in 21-day cycles in combination with carboplatin administered by IV infusion at AUC5 at Day 1 of each 21-day cycle.
Dose expansion in platinum-sensitive ovarian cancer participants. Rebastinib 50 mg BID PO in 21-day cycles in combination with carboplatin administered by IV infusion at AUC5 at Day 1 of each 21-day cycle.
Dose expansion in platinum-sensitive ovarian cancer participants. Rebastinib 100 mg BID PO in 21-day cycles in combination with carboplatin administered by IV infusion at AUC5 at Day 1 of each 21-day cycle.
Dose expansion in mesothelioma participants. Rebastinib 50 mg BID PO in 21-day cycles in combination with carboplatin administered by IV infusion at AUC5 at Day 1 of each 21-day cycle.
Dose expansion in mesothelioma participants. Rebastinib 100 mg BID PO in 21-day cycles in combination with carboplatin administered by IV infusion at AUC5 at Day 1 of each 21-day cycle.
FG0003 subjects
FG00114 subjects
FG0025 subjects
FG0039 subjects
FG0042 subjects
FG00518 subjects
FG0062 subjects
FG0076 subjects
FG00811 subjects
mITT Population
Modified Intent-to-Treat (mITT) Population includes all participants who had at least one full dose of the combined study drugs, had measurable disease at baseline, and had at least one post-baseline assessment. Participants without a post-baseline assessment who discontinued study treatment due to clinical progression, death, or a rebastinib-related AE will also be included in the mITT population.
Dose escalation with rebastinib 50 mg BID PO in 21-day cycles in combination with carboplatin administered by IV infusion at AUC5 at Day 1 of each 21-day cycle.
Dose escalation with rebastinib 100 mg BID PO in 21-day cycles in combination with carboplatin administered by IV infusion at AUC5 at Day 1 of each 21-day cycle.
Dose escalation with rebastinib 100 mg BID PO in 21-day cycles in combination with carboplatin administered by IV infusion at AUC6 at Day 1 of each 21-day cycle.
Dose expansion in TNBC participants. Rebastinib 50 mg BID PO in 21-day cycles in combination with carboplatin administered by IV infusion at AUC5 at Day 1 of each 21-day cycle.
Dose expansion in TNBC participants. Rebastinib 100 mg BID PO in 21-day cycles in combination with carboplatin administered by IV infusion at AUC5 at Day 1 of each 21-day cycle.
Dose expansion in platinum-sensitive ovarian cancer participants. Rebastinib 50 mg BID PO in 21-day cycles in combination with carboplatin administered by IV infusion at AUC5 at Day 1 of each 21-day cycle.
Dose expansion in platinum-sensitive ovarian cancer participants. Rebastinib 100 mg BID PO in 21-day cycles in combination with carboplatin administered by IV infusion at AUC5 at Day 1 of each 21-day cycle.
Dose expansion in mesothelioma participants. Rebastinib 50 mg BID PO in 21-day cycles in combination with carboplatin administered by IV infusion at AUC5 at Day 1 of each 21-day cycle.
Dose expansion in mesothelioma participants. Rebastinib 100 mg BID PO in 21-day cycles in combination with carboplatin administered by IV infusion at AUC5 at Day 1 of each 21-day cycle.
BG009
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG0003
BG00114
BG0025
BG0039
BG0042
BG00518
BG0062
BG0076
BG00811
BG00970
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Categorical
Count of Participants
Participants
No
Title
Denominators
Categories
Title
Measurements
<=18 years
BG0000
BG0010
BG0020
BG003
Sex: Female, Male
Count of Participants
Participants
No
Title
Denominators
Categories
Title
Measurements
Female
BG0003
BG0018
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
No
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0002
BG0012
BG002
Race (NIH/OMB)
Count of Participants
Participants
No
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0000
BG0010
BG002
Region of Enrollment
Number
participants
Title
Denominators
Categories
United States
Title
Measurements
BG0003
BG00114
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 Adverse Events
Number of participants who experienced serious adverse events (SAE) and adverse events (AE).
Dose escalation with rebastinib 50 mg BID PO in 21-day cycles in combination with carboplatin administered by IV infusion at AUC5 at Day 1 of each 21-day cycle.
Dose escalation with rebastinib 100 mg BID PO in 21-day cycles in combination with carboplatin administered by IV infusion at AUC5 at Day 1 of each 21-day cycle.
Dose escalation with rebastinib 100 mg BID PO in 21-day cycles in combination with carboplatin administered by IV infusion at AUC6 at Day 1 of each 21-day cycle.
Dose expansion in TNBC participants. Rebastinib 50 mg BID PO in 21-day cycles in combination with carboplatin administered by IV infusion at AUC5 at Day 1 of each 21-day cycle.
Dose expansion in TNBC participants. Rebastinib 100 mg BID PO in 21-day cycles in combination with carboplatin administered by IV infusion at AUC5 at Day 1 of each 21-day cycle.
Dose expansion in platinum-sensitive ovarian cancer participants. Rebastinib 50 mg BID PO in 21-day cycles in combination with carboplatin administered by IV infusion at AUC5 at Day 1 of each 21-day cycle.
Dose expansion in platinum-sensitive ovarian cancer participants. Rebastinib 100 mg BID PO in 21-day cycles in combination with carboplatin administered by IV infusion at AUC5 at Day 1 of each 21-day cycle.
Dose expansion in mesothelioma participants. Rebastinib 50 mg BID PO in 21-day cycles in combination with carboplatin administered by IV infusion at AUC5 at Day 1 of each 21-day cycle.
Dose expansion in mesothelioma participants. Rebastinib 100 mg BID PO in 21-day cycles in combination with carboplatin administered by IV infusion at AUC5 at Day 1 of each 21-day cycle.
Percentage of participants who achieved an objective response of Complete Response (CR) or Partial Response (PR) per Response Evaluation Criteria in Solid Tumor (RECIST) v1.1. CR is defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) had to have reduction in short axis to <10 mm. PR is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Disease progression is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study including baseline; or the appearance of one or more new lesions.
Expansion Phase mITT participants that were evaluable for this outcome measure.
Posted
Number
90% Confidence Interval
percentage of participants
Time from CR or PR to disease progression or death due to any cause (Up to 1.53 years)
Dose expansion in TNBC participants. Rebastinib 50 mg BID PO in 21-day cycles in combination with carboplatin administered by IV infusion at AUC5 at Day 1 of each 21-day cycle.
Dose expansion in TNBC participants. Rebastinib 100 mg BID PO in 21-day cycles in combination with carboplatin administered by IV infusion at AUC5 at Day 1 of each 21-day cycle.
Percentage of participants who achieved an objective response of Complete Response (CR) or Partial Response (PR) per Response Evaluation Criteria in Solid Tumor (RECIST) v1.1. CR is defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) had to have reduction in short axis to <10 mm. PR is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Disease progression is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study including baseline; or the appearance of one or more new lesions.
Escalation Phase mITT participants that were evaluable for this outcome measure.
Posted
Number
90% Confidence Interval
percentage of participants
Time from CR or PR to disease progression or death due to any cause (Up to 1.53 years)
Dose escalation with rebastinib 50 mg BID PO in 21-day cycles in combination with carboplatin administered by IV infusion at AUC5 at Day 1 of each 21-day cycle.
Dose escalation with rebastinib 100 mg BID PO in 21-day cycles in combination with carboplatin administered by IV infusion at AUC5 at Day 1 of each 21-day cycle.
Secondary
Duration of Response (DOR)
Time from first partial response (PR) or complete response (CR) to disease progression (PD) or death due to any cause. Evaluation of radiographic disease assessment per Response Evaluation Criteria in Solid Tumor (RECIST v1.1). CR is defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) had to have reduction in short axis to <10 mm. PR is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Disease progression is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study including baseline; or the appearance of one or more new lesions.
mITT participants that had CR or PR and were evaluable for this outcome measure.
Posted
Median
90% Confidence Interval
months
Time from PR or CR to PD or Death due to Any Cause (up to 1.53 years)
Dose escalation with rebastinib 50 mg BID PO in 21-day cycles in combination with carboplatin administered by IV infusion at AUC5 at Day 1 of each 21-day cycle.
Dose escalation with rebastinib 100 mg BID PO in 21-day cycles in combination with carboplatin administered by IV infusion at AUC5 at Day 1 of each 21-day cycle.
Secondary
Time to Progression (TTP)
Time from first dose of study drug to the first documentation of progressive disease (PD). Participants were considered to have progressive disease if they had documented progression based on radiologic assessment according to RECIST v1.1. RECIST v1.1 defined disease progression as at least a 20% increase in the sum of the disease measurements for measurable lesions, taking as reference the smallest disease measurement recorded since the start of treatment, or the appearance of one or more new lesions.
mITT participants that were evaluable for this outcome measure.
Dose escalation with rebastinib 50 mg BID PO in 21-day cycles in combination with carboplatin administered by IV infusion at AUC5 at Day 1 of each 21-day cycle.
Dose escalation with rebastinib 100 mg BID PO in 21-day cycles in combination with carboplatin administered by IV infusion at AUC5 at Day 1 of each 21-day cycle.
Time from first dose of study drug to disease progression (PD) or death due to any cause. Participants who undergo surgical resection of target or non-target lesions, who have received other anticancer treatments, including surgical resection or radiation (other than palliative radiation to pre-existing bone metastases'), or who do not have a documented date of progression or death due to any cause will be censored at the date of the last assessment. Disease progression per RECIST v1.1 is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study including baseline; or the appearance of one or more new lesions.
mITT participants that were evaluable for this outcome measure.
Posted
Median
90% Confidence Interval
months
First Dose of Study Drug to PD or Death due to Any Cause (up to 1.63 years)
Dose escalation with rebastinib 50 mg BID PO in 21-day cycles in combination with carboplatin administered by IV infusion at AUC5 at Day 1 of each 21-day cycle.
Dose escalation with rebastinib 100 mg BID PO in 21-day cycles in combination with carboplatin administered by IV infusion at AUC5 at Day 1 of each 21-day cycle.
Secondary
Overall Survival (OS)
Time from baseline C1 D1 to date of death due to any cause. Participants who are still alive or who are lost to follow-up will be censored at the date of last contact.
mITT participants that were evaluable for this outcome measure.
Posted
Median
90% Confidence Interval
months
Baseline to death due to any cause (Up to 2.12 years)
Dose escalation with rebastinib 50 mg BID PO in 21-day cycles in combination with carboplatin administered by IV infusion at AUC5 at Day 1 of each 21-day cycle.
Dose escalation with rebastinib 100 mg BID PO in 21-day cycles in combination with carboplatin administered by IV infusion at AUC5 at Day 1 of each 21-day cycle.
Dose escalation with rebastinib 100 mg BID PO in 21-day cycles in combination with carboplatin administered by IV infusion at AUC6 at Day 1 of each 21-day cycle.
OG003
Secondary
Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of Rebastinib (Part 1)
Cmax of rebastinib
Part 1 participants who received any study drug and had evaluable Cmax data at each timepoint.
Posted
Geometric Mean
Geometric Coefficient of Variation
Nanograms per milliliter (ng/mL)
Part 1: Cycle (C) 1 Day (D) 1, C2 D1 (Cycle = 21 Days)
Dose escalation with rebastinib 50 mg BID PO in 21-day cycles in combination with carboplatin administered by IV infusion at AUC5 at Day 1 of each 21-day cycle.
Dose escalation with rebastinib 100 mg BID PO in 21-day cycles in combination with carboplatin administered by IV infusion at AUC5 at Day 1 of each 21-day cycle.
Dose escalation with rebastinib 100 mg BID PO in 21-day cycles in combination with carboplatin administered by IV infusion at AUC6 at Day 1 of each 21-day cycle.
Secondary
PK: Area Under the Concentration-time Curve 0-3 Hours (AUC 0-3 Hours) (Part 1)
Measure the AUC 0-3 hours
Part 1 participants who received any study drug and had evaluable AUC data at each timepoint.
Posted
Geometric Mean
Geometric Coefficient of Variation
Nanograms hour per milliliter (ng*h/mL)
Part 1: Cycle (C) 1 Day (D) 1, C2 D1 (Cycle = 21 Days)
Dose escalation with rebastinib 50 mg BID PO in 21-day cycles in combination with carboplatin administered by IV infusion at AUC5 at Day 1 of each 21-day cycle.
Dose escalation with rebastinib 100 mg BID PO in 21-day cycles in combination with carboplatin administered by IV infusion at AUC5 at Day 1 of each 21-day cycle.
Dose escalation with rebastinib 100 mg BID PO in 21-day cycles in combination with carboplatin administered by IV infusion at AUC6 at Day 1 of each 21-day cycle.
Dose escalation with rebastinib 50 mg BID PO in 21-day cycles in combination with carboplatin administered by IV infusion at AUC5 at Day 1 of each 21-day cycle.
Dose escalation with rebastinib 100 mg BID PO in 21-day cycles in combination with carboplatin administered by IV infusion at AUC5 at Day 1 of each 21-day cycle.
Dose escalation with rebastinib 100 mg BID PO in 21-day cycles in combination with carboplatin administered by IV infusion at AUC6 at Day 1 of each 21-day cycle.
Dose expansion in TNBC participants. Rebastinib 50 mg BID PO in 21-day cycles in combination with carboplatin administered by IV infusion at AUC5 at Day 1 of each 21-day cycle.
Dose expansion in TNBC participants. Rebastinib 100 mg BID PO in 21-day cycles in combination with carboplatin administered by IV infusion at AUC5 at Day 1 of each 21-day cycle.
Dose expansion in platinum-sensitive ovarian cancer participants. Rebastinib 50 mg BID PO in 21-day cycles in combination with carboplatin administered by IV infusion at AUC5 at Day 1 of each 21-day cycle.
Dose expansion in platinum-sensitive ovarian cancer participants. Rebastinib 100 mg BID PO in 21-day cycles in combination with carboplatin administered by IV infusion at AUC5 at Day 1 of each 21-day cycle.
Dose expansion in mesothelioma participants. Rebastinib 50 mg BID PO in 21-day cycles in combination with carboplatin administered by IV infusion at AUC5 at Day 1 of each 21-day cycle.
Dose expansion in mesothelioma participants. Rebastinib 100 mg BID PO in 21-day cycles in combination with carboplatin administered by IV infusion at AUC5 at Day 1 of each 21-day cycle.
3
11
6
11
11
11
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Cardiac failure
Cardiac disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected5 at risk
EG0031 events1 affected9 at risk
EG0040 events0 affected2 at risk
EG0050 events0 affected18 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected6 at risk
EG0080 events0 affected11 at risk
Coronary artery disease
Cardiac disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected5 at risk
EG003
Myocardial infarction
Cardiac disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected5 at risk
EG003
Pericardial effusion
Cardiac disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected5 at risk
EG003
Retinal vascular disorder
Eye disorders
MedDRA v24.1
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected5 at risk
EG003
Retinal vein occlusion
Eye disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected5 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected14 at risk
EG0020 events0 affected5 at risk
EG003
Gastric stenosis
Gastrointestinal disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected5 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected5 at risk
EG003
Oesophagitis
Gastrointestinal disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected5 at risk
EG003
Small intestinal obstruction
Gastrointestinal disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0013 events1 affected14 at risk
EG0020 events0 affected5 at risk
EG003
Asthenia
General disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected5 at risk
EG003
Death
General disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected14 at risk
EG0021 events1 affected5 at risk
EG003
Pyrexia
General disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected5 at risk
EG003
Pneumonia
Infections and infestations
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected14 at risk
EG0020 events0 affected5 at risk
EG003
Urinary tract infection bacterial
Infections and infestations
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected5 at risk
EG003
Infusion related reaction
Injury, poisoning and procedural complications
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected5 at risk
EG003
Failure to thrive
Metabolism and nutrition disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected5 at risk
EG003
Costochondritis
Musculoskeletal and connective tissue disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected5 at risk
EG003
Muscular weakness
Musculoskeletal and connective tissue disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected5 at risk
EG003
Malignant pleural effusion
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA v24.1
Systematic Assessment
EG0001 events1 affected3 at risk
EG0011 events1 affected14 at risk
EG0020 events0 affected5 at risk
EG003
Metastases to central nervous system
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected5 at risk
EG003
Asthma
Respiratory, thoracic and mediastinal disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected14 at risk
EG0020 events0 affected5 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected5 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected14 at risk
EG0020 events0 affected5 at risk
EG003
Wound treatment
Surgical and medical procedures
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected5 at risk
EG003
Deep vein thrombosis
Vascular disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected5 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA v24.1
Systematic Assessment
EG0001 events1 affected3 at risk
EG0014 events3 affected14 at risk
EG0020 events0 affected5 at risk
EG0033 events1 affected9 at risk
EG0040 events0 affected2 at risk
EG0055 events3 affected18 at risk
EG0061 events1 affected2 at risk
EG0071 events1 affected6 at risk
EG0085 events2 affected11 at risk
Leukopenia
Blood and lymphatic system disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0012 events2 affected14 at risk
EG0020 events0 affected5 at risk
EG003
Neutropenia
Blood and lymphatic system disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected14 at risk
EG0021 events1 affected5 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA v24.1
Systematic Assessment
EG0002 events1 affected3 at risk
EG0019 events5 affected14 at risk
EG0022 events2 affected5 at risk
EG003
Atrial fibrillation
Cardiac disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected5 at risk
EG003
Conduction disorder
Cardiac disorders
MedDRA v24.1
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected5 at risk
EG003
Extrasystoles
Cardiac disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected5 at risk
EG003
Pericardial effusion
Cardiac disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected5 at risk
EG003
Sinus bradycardia
Cardiac disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected5 at risk
EG003
Sinus tachycardia
Cardiac disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected5 at risk
EG003
Tachycardia
Cardiac disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected5 at risk
EG003
Corneal dystrophy
Congenital, familial and genetic disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected5 at risk
EG003
Tinnitus
Ear and labyrinth disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected5 at risk
EG003
Vertigo
Ear and labyrinth disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected5 at risk
EG003
Addison's disease
Endocrine disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected14 at risk
EG0020 events0 affected5 at risk
EG003
Borderline glaucoma
Eye disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected5 at risk
EG003
Cataract
Eye disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected5 at risk
EG003
Dry eye
Eye disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected14 at risk
EG0021 events1 affected5 at risk
EG003
Glaucoma
Eye disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected5 at risk
EG003
Ocular hypertension
Eye disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected5 at risk
EG003
Photopsia
Eye disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0012 events1 affected14 at risk
EG0020 events0 affected5 at risk
EG003
Refraction disorder
Eye disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected5 at risk
EG003
Retinal haemorrhage
Eye disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected5 at risk
EG003
Retinal tear
Eye disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected5 at risk
EG003
Retinal vein occlusion
Eye disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected5 at risk
EG003
Vision blurred
Eye disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0012 events2 affected14 at risk
EG0021 events1 affected5 at risk
EG003
Visual impairment
Eye disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected14 at risk
EG0021 events1 affected5 at risk
EG003
Vitreous detachment
Eye disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected5 at risk
EG003
Abdominal discomfort
Gastrointestinal disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected5 at risk
EG003
Abdominal distension
Gastrointestinal disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0012 events1 affected14 at risk
EG0020 events0 affected5 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0012 events2 affected14 at risk
EG0020 events0 affected5 at risk
EG003
Ascites
Gastrointestinal disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected14 at risk
EG0020 events0 affected5 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0015 events5 affected14 at risk
EG0021 events1 affected5 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected14 at risk
EG0021 events1 affected5 at risk
EG003
Dry mouth
Gastrointestinal disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0012 events1 affected14 at risk
EG0021 events1 affected5 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA v24.1
Systematic Assessment
EG0001 events1 affected3 at risk
EG0012 events2 affected14 at risk
EG0020 events0 affected5 at risk
EG003
Eructation
Gastrointestinal disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected5 at risk
EG003
Flatulence
Gastrointestinal disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected5 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected14 at risk
EG0021 events1 affected5 at risk
EG003
Gingival pain
Gastrointestinal disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected5 at risk
EG003
Hypoaesthesia oral
Gastrointestinal disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected14 at risk
EG0021 events1 affected5 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0014 events3 affected14 at risk
EG0022 events2 affected5 at risk
EG003
Oral pain
Gastrointestinal disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected5 at risk
EG003
Proctalgia
Gastrointestinal disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected5 at risk
EG003
Stomatitis
Gastrointestinal disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected5 at risk
EG003
Swollen tongue
Gastrointestinal disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected14 at risk
EG0021 events1 affected5 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected14 at risk
EG0021 events1 affected5 at risk
EG003
Asthenia
General disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected14 at risk
EG0021 events1 affected5 at risk
EG003
Chest discomfort
General disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected5 at risk
EG003
Chills
General disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected14 at risk
EG0021 events1 affected5 at risk
EG003
Fatigue
General disorders
MedDRA v24.1
Systematic Assessment
EG0001 events1 affected3 at risk
EG0015 events3 affected14 at risk
EG0023 events2 affected5 at risk
EG003
Feeling jittery
General disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected14 at risk
EG0020 events0 affected5 at risk
EG003
Infusion site extravasation
General disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected5 at risk
EG003
Non-cardiac chest pain
General disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected14 at risk
EG0020 events0 affected5 at risk
EG003
Oedema peripheral
General disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected5 at risk
EG003
Peripheral swelling
General disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected14 at risk
EG0020 events0 affected5 at risk
EG003
Pyrexia
General disorders
MedDRA v24.1
Systematic Assessment
EG0002 events2 affected3 at risk
EG0011 events1 affected14 at risk
EG0020 events0 affected5 at risk
EG003
Anaphylactic reaction
Immune system disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected5 at risk
EG003
COVID-19
Infections and infestations
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected5 at risk
EG003
Ear infection
Infections and infestations
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected14 at risk
EG0020 events0 affected5 at risk
EG003
Herpes zoster
Infections and infestations
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected5 at risk
EG003
Pneumonia
Infections and infestations
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected14 at risk
EG0021 events1 affected5 at risk
EG003
Pustule
Infections and infestations
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected14 at risk
EG0020 events0 affected5 at risk
EG003
Skin infection
Infections and infestations
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected5 at risk
EG003
Tooth infection
Infections and infestations
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected5 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected5 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected5 at risk
EG003
Vulvovaginal mycotic infection
Infections and infestations
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected5 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected14 at risk
EG0021 events1 affected5 at risk
EG003
Infusion related reaction
Injury, poisoning and procedural complications
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0012 events1 affected14 at risk
EG0020 events0 affected5 at risk
EG003
Skin abrasion
Injury, poisoning and procedural complications
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected5 at risk
EG003
Tooth fracture
Injury, poisoning and procedural complications
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected14 at risk
EG0021 events1 affected5 at risk
EG003
Vascular access complication
Injury, poisoning and procedural complications
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected5 at risk
EG003
Activated partial thromboplastin time prolonged
Investigations
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected5 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0012 events2 affected14 at risk
EG0021 events1 affected5 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0012 events2 affected14 at risk
EG0021 events1 affected5 at risk
EG003
Blood alkaline phosphatase increased
Investigations
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected14 at risk
EG0021 events1 affected5 at risk
EG003
Blood creatine phosphokinase increased
Investigations
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected5 at risk
EG003
Blood creatinine increased
Investigations
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected5 at risk
EG003
Blood lactate dehydrogenase decreased
Investigations
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected5 at risk
EG003
Blood lactate dehydrogenase increased
Investigations
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected5 at risk
EG003
Blood phosphorus decreased
Investigations
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected14 at risk
EG0021 events1 affected5 at risk
EG003
Blood thyroid stimulating hormone increased
Investigations
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected5 at risk
EG003
Ejection fraction decreased
Investigations
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected5 at risk
EG003
Electrocardiogram QT prolonged
Investigations
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected5 at risk
EG003
Intraocular pressure increased
Investigations
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0012 events2 affected14 at risk
EG0020 events0 affected5 at risk
EG003
Lymphocyte count decreased
Investigations
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected5 at risk
EG003
Neutrophil count decreased
Investigations
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0013 events3 affected14 at risk
EG0020 events0 affected5 at risk
EG003
Platelet count decreased
Investigations
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected14 at risk
EG0021 events1 affected5 at risk
EG003
Weight decreased
Investigations
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected5 at risk
EG003
Weight increased
Investigations
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected5 at risk
EG003
White blood cell count decreased
Investigations
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected14 at risk
EG0020 events0 affected5 at risk
EG003
Cachexia
Metabolism and nutrition disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected14 at risk
EG0020 events0 affected5 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected14 at risk
EG0021 events1 affected5 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA v24.1
Systematic Assessment
EG0001 events1 affected3 at risk
EG0011 events1 affected14 at risk
EG0020 events0 affected5 at risk
EG003
Hypoalbuminaemia
Metabolism and nutrition disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected5 at risk
EG003
Hypocalcaemia
Metabolism and nutrition disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected5 at risk
EG003
Hypoglycaemia
Metabolism and nutrition disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected5 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected14 at risk
EG0020 events0 affected5 at risk
EG003
Hypomagnesaemia
Metabolism and nutrition disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected5 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected14 at risk
EG0020 events0 affected5 at risk
EG003
Hypophosphataemia
Metabolism and nutrition disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected5 at risk
EG003
Polydipsia
Metabolism and nutrition disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected14 at risk
EG0021 events1 affected5 at risk
EG003
Vitamin B complex deficiency
Metabolism and nutrition disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected5 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA v24.1
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected14 at risk
EG0023 events2 affected5 at risk
EG003
Arthritis
Musculoskeletal and connective tissue disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected5 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA v24.1
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected5 at risk
EG003
Flank pain
Musculoskeletal and connective tissue disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected5 at risk
EG003
Limb discomfort
Musculoskeletal and connective tissue disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected5 at risk
EG003
Muscle atrophy
Musculoskeletal and connective tissue disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected5 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected5 at risk
EG003
Muscular weakness
Musculoskeletal and connective tissue disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0012 events1 affected14 at risk
EG0020 events0 affected5 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected5 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected5 at risk
EG003
Acrochordon
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected14 at risk
EG0020 events0 affected5 at risk
EG003
Haemangioma of skin
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected14 at risk
EG0021 events1 affected5 at risk
EG003
Melanocytic naevus
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected5 at risk
EG003
Squamous cell carcinoma of skin
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected14 at risk
EG0020 events0 affected5 at risk
EG003
Tumour pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected14 at risk
EG0020 events0 affected5 at risk
EG003
Dizziness
Nervous system disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected14 at risk
EG0022 events1 affected5 at risk
EG003
Dysgeusia
Nervous system disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected5 at risk
EG003
Headache
Nervous system disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0013 events3 affected14 at risk
EG0020 events0 affected5 at risk
EG003
Hemiparesis
Nervous system disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected5 at risk
EG003
Hypoaesthesia
Nervous system disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected14 at risk
EG0021 events1 affected5 at risk
EG003
Paraesthesia
Nervous system disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected14 at risk
EG0020 events0 affected5 at risk
EG003
Peripheral sensory neuropathy
Nervous system disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0015 events3 affected14 at risk
EG0020 events0 affected5 at risk
EG003
Speech disorder
Nervous system disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected14 at risk
EG0021 events1 affected5 at risk
EG003
Syncope
Nervous system disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected14 at risk
EG0020 events0 affected5 at risk
EG003
Taste disorder
Nervous system disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected14 at risk
EG0020 events0 affected5 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA v24.1
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected5 at risk
EG003
Confusional state
Psychiatric disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected14 at risk
EG0020 events0 affected5 at risk
EG003
Depression
Psychiatric disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected14 at risk
EG0020 events0 affected5 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA v24.1
Systematic Assessment
EG0001 events1 affected3 at risk
EG0011 events1 affected14 at risk
EG0020 events0 affected5 at risk
EG003
Mental status changes
Psychiatric disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected14 at risk
EG0020 events0 affected5 at risk
EG003
Acute kidney injury
Renal and urinary disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected5 at risk
EG003
Dysuria
Renal and urinary disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected14 at risk
EG0021 events1 affected5 at risk
EG003
Micturition urgency
Renal and urinary disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected5 at risk
EG003
Proteinuria
Renal and urinary disorders
MedDRA v24.1
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected5 at risk
EG003
Urinary retention
Renal and urinary disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected5 at risk
EG003
Pelvic pain
Reproductive system and breast disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected5 at risk
EG003
Penile pain
Reproductive system and breast disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected5 at risk
EG003
Atelectasis
Respiratory, thoracic and mediastinal disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected5 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA v24.1
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected14 at risk
EG0021 events1 affected5 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA v24.1
Systematic Assessment
EG0001 events1 affected3 at risk
EG0011 events1 affected14 at risk
EG0020 events0 affected5 at risk
EG003
Dyspnoea exertional
Respiratory, thoracic and mediastinal disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected5 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected5 at risk
EG003
Hypoxia
Respiratory, thoracic and mediastinal disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected5 at risk
EG003
Nasal dryness
Respiratory, thoracic and mediastinal disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected14 at risk
EG0021 events1 affected5 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected14 at risk
EG0020 events0 affected5 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected5 at risk
EG003
Pleuritic pain
Respiratory, thoracic and mediastinal disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected5 at risk
EG003
Productive cough
Respiratory, thoracic and mediastinal disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected5 at risk
EG003
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected14 at risk
EG0020 events0 affected5 at risk
EG003
Respiratory failure
Respiratory, thoracic and mediastinal disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected5 at risk
EG003
Upper-airway cough syndrome
Respiratory, thoracic and mediastinal disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected14 at risk
EG0020 events0 affected5 at risk
EG003
Actinic keratosis
Skin and subcutaneous tissue disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected14 at risk
EG0020 events0 affected5 at risk
EG003
Dry skin
Skin and subcutaneous tissue disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected5 at risk
EG003
Eczema
Skin and subcutaneous tissue disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected5 at risk
EG003
Erythema
Skin and subcutaneous tissue disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected14 at risk
EG0020 events0 affected5 at risk
EG003
Hyperhidrosis
Skin and subcutaneous tissue disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected5 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected14 at risk
EG0021 events1 affected5 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected5 at risk
EG003
Rash macular
Skin and subcutaneous tissue disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected5 at risk
EG003
Rash maculo-papular
Skin and subcutaneous tissue disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected5 at risk
EG003
Rash pruritic
Skin and subcutaneous tissue disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected5 at risk
EG003
Skin burning sensation
Skin and subcutaneous tissue disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected5 at risk
EG003
Skin ulcer
Skin and subcutaneous tissue disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected5 at risk
EG003
Deep vein thrombosis
Vascular disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected5 at risk
EG003
Flushing
Vascular disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected5 at risk
EG003
Hot flush
Vascular disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected5 at risk
EG003
Hypertension
Vascular disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0012 events2 affected14 at risk
EG0020 events0 affected5 at risk
EG003
Peripheral coldness
Vascular disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected5 at risk
EG003
Superficial vein thrombosis
Vascular disorders
MedDRA v24.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected5 at risk
EG003
Trial terminated on May 23, 2022, due to development program termination.
Dose expansion in platinum-sensitive ovarian cancer participants. Rebastinib 50 mg BID PO in 21-day cycles in combination with carboplatin administered by IV infusion at AUC5 at Day 1 of each 21-day cycle.
Dose expansion in platinum-sensitive ovarian cancer participants. Rebastinib 100 mg BID PO in 21-day cycles in combination with carboplatin administered by IV infusion at AUC5 at Day 1 of each 21-day cycle.
Dose expansion in mesothelioma participants. Rebastinib 50 mg BID PO in 21-day cycles in combination with carboplatin administered by IV infusion at AUC5 at Day 1 of each 21-day cycle.
Dose expansion in mesothelioma participants. Rebastinib 100 mg BID PO in 21-day cycles in combination with carboplatin administered by IV infusion at AUC5 at Day 1 of each 21-day cycle.
Dose escalation with rebastinib 100 mg BID PO in 21-day cycles in combination with carboplatin administered by IV infusion at AUC6 at Day 1 of each 21-day cycle.
Dose escalation with rebastinib 100 mg BID PO in 21-day cycles in combination with carboplatin administered by IV infusion at AUC6 at Day 1 of each 21-day cycle.
Dose expansion in TNBC participants. Rebastinib 50 mg BID PO in 21-day cycles in combination with carboplatin administered by IV infusion at AUC5 at Day 1 of each 21-day cycle.
Dose expansion in TNBC participants. Rebastinib 100 mg BID PO in 21-day cycles in combination with carboplatin administered by IV infusion at AUC5 at Day 1 of each 21-day cycle.
Dose expansion in platinum-sensitive ovarian cancer participants. Rebastinib 50 mg BID PO in 21-day cycles in combination with carboplatin administered by IV infusion at AUC5 at Day 1 of each 21-day cycle.
Dose expansion in platinum-sensitive ovarian cancer participants. Rebastinib 100 mg BID PO in 21-day cycles in combination with carboplatin administered by IV infusion at AUC5 at Day 1 of each 21-day cycle.
Dose expansion in mesothelioma participants. Rebastinib 50 mg BID PO in 21-day cycles in combination with carboplatin administered by IV infusion at AUC5 at Day 1 of each 21-day cycle.
Dose expansion in mesothelioma participants. Rebastinib 100 mg BID PO in 21-day cycles in combination with carboplatin administered by IV infusion at AUC5 at Day 1 of each 21-day cycle.
Units
Counts
Participants
OG0000
OG0010
OG0020
OG0030
OG0040
OG0053
OG0062
OG0070
OG0080
Title
Denominators
Categories
Title
Measurements
OG00511.8(NA to NA)The 90% Confidence Interval (CI) was not estimable due to insufficient number of events.
OG00613.5(8.6 to NA)The 90% CI was not estimable due to insufficient number of events.
Dose escalation with rebastinib 100 mg BID PO in 21-day cycles in combination with carboplatin administered by IV infusion at AUC6 at Day 1 of each 21-day cycle.
Dose expansion in TNBC participants. Rebastinib 50 mg BID PO in 21-day cycles in combination with carboplatin administered by IV infusion at AUC5 at Day 1 of each 21-day cycle.
Dose expansion in TNBC participants. Rebastinib 100 mg BID PO in 21-day cycles in combination with carboplatin administered by IV infusion at AUC5 at Day 1 of each 21-day cycle.
Dose expansion in platinum-sensitive ovarian cancer participants. Rebastinib 50 mg BID PO in 21-day cycles in combination with carboplatin administered by IV infusion at AUC5 at Day 1 of each 21-day cycle.
Dose expansion in platinum-sensitive ovarian cancer participants. Rebastinib 100 mg BID PO in 21-day cycles in combination with carboplatin administered by IV infusion at AUC5 at Day 1 of each 21-day cycle.
Dose expansion in mesothelioma participants. Rebastinib 50 mg BID PO in 21-day cycles in combination with carboplatin administered by IV infusion at AUC5 at Day 1 of each 21-day cycle.
Dose expansion in mesothelioma participants. Rebastinib 100 mg BID PO in 21-day cycles in combination with carboplatin administered by IV infusion at AUC5 at Day 1 of each 21-day cycle.
Units
Counts
Participants
OG0002
OG0016
OG0024
OG0037
OG0042
OG00511
OG0062
OG0072
OG0086
Title
Denominators
Categories
Title
Measurements
OG0001.4(0.9 to NA)The 90% CI was not estimable due to insufficient number of events.
OG0014.0(1.4 to NA)The 90% CI was not estimable due to insufficient number of events.
OG0022.3(1.2 to NA)The 90% CI was not estimable due to insufficient number of events.
OG0031.5(1.1 to 3.2)
OG0041.3(1.2 to NA)The 90% CI was not estimable due to insufficient number of events.
OG0056.7(4.6 to 13.3)
OG00614.6(9.8 to NA)The 90% CI was not estimable due to insufficient number of events.
OG007NA(4.5 to NA)TTP median and 90% CI were not estimable due to insufficient number of events.
OG0084.9(3.2 to NA)The 90% CI was not estimable due to insufficient number of events.
Dose escalation with rebastinib 100 mg BID PO in 21-day cycles in combination with carboplatin administered by IV infusion at AUC6 at Day 1 of each 21-day cycle.
Dose expansion in TNBC participants. Rebastinib 50 mg BID PO in 21-day cycles in combination with carboplatin administered by IV infusion at AUC5 at Day 1 of each 21-day cycle.
Dose expansion in TNBC participants. Rebastinib 100 mg BID PO in 21-day cycles in combination with carboplatin administered by IV infusion at AUC5 at Day 1 of each 21-day cycle.
Dose expansion in platinum-sensitive ovarian cancer participants. Rebastinib 50 mg BID PO in 21-day cycles in combination with carboplatin administered by IV infusion at AUC5 at Day 1 of each 21-day cycle.
Dose expansion in platinum-sensitive ovarian cancer participants. Rebastinib 100 mg BID PO in 21-day cycles in combination with carboplatin administered by IV infusion at AUC5 at Day 1 of each 21-day cycle.
Dose expansion in mesothelioma participants. Rebastinib 50 mg BID PO in 21-day cycles in combination with carboplatin administered by IV infusion at AUC5 at Day 1 of each 21-day cycle.
Dose expansion in mesothelioma participants. Rebastinib 100 mg BID PO in 21-day cycles in combination with carboplatin administered by IV infusion at AUC5 at Day 1 of each 21-day cycle.
Units
Counts
Participants
OG0003
OG00112
OG0025
OG0039
OG0042
OG00518
OG0062
OG0076
OG00811
Title
Denominators
Categories
Title
Measurements
OG0001.4(0.9 to NA)The 90% CI was not estimable due to insufficient number of events.
OG0014.0(1.4 to NA)The 90% CI was not estimable due to insufficient number of events.
OG0022.3(1.2 to NA)The 90% CI was not estimable due to insufficient number of events.
OG0031.5(1.1 to 3.2)
OG0041.3(1.2 to NA)The 90% CI was not estimable due to insufficient number of events.
OG0056.7(4.6 to 13.3)
OG00614.6(9.8 to NA)The 90% CI was not estimable due to insufficient number of events.
OG007NA(4.5 to NA)PFS median and 90% CI were not estimable due to insufficient number of events.
Dose expansion in TNBC participants. Rebastinib 50 mg BID PO in 21-day cycles in combination with carboplatin administered by IV infusion at AUC5 at Day 1 of each 21-day cycle.
Dose expansion in TNBC participants. Rebastinib 100 mg BID PO in 21-day cycles in combination with carboplatin administered by IV infusion at AUC5 at Day 1 of each 21-day cycle.
Dose expansion in platinum-sensitive ovarian cancer participants. Rebastinib 50 mg BID PO in 21-day cycles in combination with carboplatin administered by IV infusion at AUC5 at Day 1 of each 21-day cycle.
Dose expansion in platinum-sensitive ovarian cancer participants. Rebastinib 100 mg BID PO in 21-day cycles in combination with carboplatin administered by IV infusion at AUC5 at Day 1 of each 21-day cycle.
Dose expansion in mesothelioma participants. Rebastinib 50 mg BID PO in 21-day cycles in combination with carboplatin administered by IV infusion at AUC5 at Day 1 of each 21-day cycle.
Dose expansion in mesothelioma participants. Rebastinib 100 mg BID PO in 21-day cycles in combination with carboplatin administered by IV infusion at AUC5 at Day 1 of each 21-day cycle.
Units
Counts
Participants
OG0003
OG00112
OG0025
OG0039
OG0042
OG00518
OG0062
OG0076
OG00811
Title
Denominators
Categories
Title
Measurements
OG000NA(NA to NA)OS median and 90% CI were not estimable due to insufficient number of events.
OG001NA(NA to NA)OS median and 90% CI were not estimable due to insufficient number of events.
OG002NA(1.8 to NA)OS median and 90% CI were not estimable due to insufficient number of events.
OG003NA(NA to NA)OS median and 90% CI were not estimable due to insufficient number of events.
OG004NA(NA to NA)OS median and 90% CI were not estimable due to insufficient number of events.
OG005NA(NA to NA)OS median and 90% CI were not estimable due to insufficient number of events.
OG006NA(NA to NA)OS median and 90% CI were not estimable due to insufficient number of events.
OG007NA(NA to NA)OS median and 90% CI were not estimable due to insufficient number of events.
OG0089.9(4.0 to NA)The 90% CI was not estimable due to insufficient number of events.