check_circleStudy Completed

Solid tumors

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.

Key Participants Requirements

Sex

Both

Age

18 - N/A

Trial summary

Enrollment Goal
81
Trial Dates
May 2016 - December 2024
Phase
Phase 1
Could I Receive a placebo
No
Products
BAY1436032
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
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 BAY1436032
    MTD 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 days
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    Safety Issue:
    Yes
  • Number of participants with adverse events as a measure of safety and tolerability of BAY1436032
    Safety and tolerability variables will include AEs, laboratory safety tests, ECGs, and vital signs.
    date_rangeTime Frame:
    Up to 30 months
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    Safety Issue:
    Yes
  • Recommended Phase II Dose (RP2D) of BAY1436032
    If 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 months
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    Safety Issue:
    Yes

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 months
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    Safety Issue:
    No
  • Duration of response
    date_rangeTime Frame:
    Up to 30 months
  • Progression free survival (PFS)
    For expansion part only
    date_rangeTime Frame:
    Up to 30 months
  • Cmax of BAY1436032
    date_rangeTime Frame:
    on C1D-2 and C1D1
  • AUC(0-12) of BAY1436032
    date_rangeTime Frame:
    on C1D-2 and C1D1
  • AUC(0-24) of BAY1436032
    date_rangeTime Frame:
    on C1D-2 and C1D1
  • C(max,md) of BAY1436032
    date_rangeTime Frame:
    on C1D15
  • AUC(0-12)md of BAY1436032
    date_rangeTime Frame:
    on C1D15
  • Change of 2-hydroxyglutarate (2-HG) concentration in plasma from baseline
    date_rangeTime Frame:
    Up to 30 months
  • Change of 2-hydroxyglutarate (2-HG) concentration in urine from baseline
    date_rangeTime Frame:
    Up to 30 months

Trial design

An open-label, non-randomized, multicenter Phase I study to determine the maximum tolerated or recommended Phase II dose of oral mutant IDH1 inhibitor BAY1436032 and to characterize its safety, tolerability, pharmacokinetics and preliminary pharmacodynamic and anti-tumor activity in patients with IDH1-R132X-mutant advanced solid tumors
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
N/A
Blinding
Open Label
Assignment
Single Group Assignment
Trial Arms
1