check_circleStudy Completed
Solid tumors
Bayer Identifier:
18239
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
Phase I study of BAY1436032 in IDH1-mutant advanced solid tumors
Trial purpose
The primary objective of this study is:
- Determine the safety, tolerability, maximum tolerated dose (MTD) or recommended Phase II dose (RP2D) of BAY 1436032 in patients with isocitrate dehydrogenase-1 (IDH1)-R132X-mutant advanced solid tumors.
The secondary objectives of this study are:
- Evaluate the pharmacokinetics (PK) of BAY1436032 in patients with IDH1-R132X-mutant advanced solid tumors.
- Evaluate the effect of a standard high-fat, high calorie meal on the PK of BAY1436032.
- Assess pharmacodynamic (PD) effects and evidence of clinical efficacy associated with BAY1436032 administration in patients with IDH1-R132X-mutant advanced solid tumors.
- Determine the safety, tolerability, maximum tolerated dose (MTD) or recommended Phase II dose (RP2D) of BAY 1436032 in patients with isocitrate dehydrogenase-1 (IDH1)-R132X-mutant advanced solid tumors.
The secondary objectives of this study are:
- Evaluate the pharmacokinetics (PK) of BAY1436032 in patients with IDH1-R132X-mutant advanced solid tumors.
- Evaluate the effect of a standard high-fat, high calorie meal on the PK of BAY1436032.
- Assess pharmacodynamic (PD) effects and evidence of clinical efficacy associated with BAY1436032 administration in patients with IDH1-R132X-mutant advanced solid tumors.
Key Participants Requirements
Sex
BothAge
18 - N/ATrial summary
Enrollment Goal
81Trial Dates
May 2016 - December 2024Phase
Phase 1Could I Receive a placebo
NoProducts
BAY1436032Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | København Ø, 2100, Denmark | |
Completed | Los Angeles, 90012, United States | |
Completed | Heidelberg, 69115, Germany | |
Completed | Essen, 45147, Germany | |
Completed | Frankfurt, 60590, Germany | |
Completed | Tübingen, 72076, Germany | |
Completed | Los Angeles, 90001, United States | |
Completed | Nagoya, 466-8560, Japan | |
Completed | Chuo-ku, 104-0045, Japan | |
Completed | Kashiwa, 277-8577, Japan | |
Completed | Charlottesville, 22903, United States | |
Completed | Houston, 77030, United States | |
Completed | München, 81377, Germany |
Primary Outcome
- Maximum tolerated dose (MTD) of BAY1436032MTD is defined as the maximum dose at which the predicted incidence of DLTs during Cycle 1 (DLT evaluation period) is ≤25%.date_rangeTime Frame:21 daysenhanced_encryptionYesSafety Issue:
- Number of participants with adverse events as a measure of safety and tolerability of BAY1436032Safety and tolerability variables will include AEs, laboratory safety tests, ECGs, and vital signs.date_rangeTime Frame:Up to 30 monthsenhanced_encryptionYesSafety Issue:
- Recommended Phase II Dose (RP2D) of BAY1436032If the MTD is not reached, the primary variable will be the RP2D, defined based on all available safety, PK, PD, biomarker, and efficacy data collected after the start of BAY1436032 treatment.date_rangeTime Frame:Up to 20 monthsenhanced_encryptionYesSafety Issue:
Secondary Outcome
- Objective response rate (partial and complete response)Assessed by Response Evaluation Criteria in Solid Tumors (RECIST 1.1) or for gliomas Response Assessment in Neuro-Oncology (RANO)date_rangeTime Frame:Up to 30 monthsenhanced_encryptionNoSafety Issue:
- Duration of responsedate_rangeTime Frame:Up to 30 months
- Progression free survival (PFS)For expansion part onlydate_rangeTime Frame:Up to 30 months
- Cmax of BAY1436032date_rangeTime Frame:on C1D-2 and C1D1
- AUC(0-12) of BAY1436032date_rangeTime Frame:on C1D-2 and C1D1
- AUC(0-24) of BAY1436032date_rangeTime Frame:on C1D-2 and C1D1
- C(max,md) of BAY1436032date_rangeTime Frame:on C1D15
- AUC(0-12)md of BAY1436032date_rangeTime Frame:on C1D15
- Change of 2-hydroxyglutarate (2-HG) concentration in plasma from baselinedate_rangeTime Frame:Up to 30 months
- Change of 2-hydroxyglutarate (2-HG) concentration in urine from baselinedate_rangeTime Frame:Up to 30 months
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
TreatmentAllocation
N/ABlinding
Open LabelAssignment
Single Group AssignmentTrial Arms
1Additional Information
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