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Phase I Study of BAY1436032 in IDH1-mutant Advanced Solid Tumors

NCT02746081 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 81

Last updated 2024-12-18

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

BAY1436032

The selected starting dose of BAY1436032 is 300 mg/day (150 mg BID) to be administered orally continuously in tablet form in 21-day cycles. Adjustments to this schedule may be made if warranted by information collected during the course of the study. The maximum feasible dose of BAY1436032 is expected to be 3000 mg/day.

Sponsors & Collaborators

Principal Investigators

  • Bayer Study Director · Bayer

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-05-26
Primary Completion
2018-11-08
Completion
2024-12-03
FDA Drug
Yes

Countries

  • United States
  • Denmark
  • Germany
  • Japan

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02746081 on ClinicalTrials.gov