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Small Molecule Inhibitor

BAY1436032 for Solid Tumors

Phase 1
Waitlist Available
Research Sponsored by Bayer
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients with a histologically confirmed solid tumor with an IDH1-R132X mutation
Patient must be able to provide a formalin-fixed and paraffin-embedded (FFPE) tumor tissue specimen prior to treatment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 30 months
Awards & highlights

Study Summary

This trial is testing a new drug, BAY1436032, to see if it is safe and effective in patients with IDH1-R132X-mutant advanced solid tumors. The trial will also assess the drug's pharmacokinetics and pharmacodynamics.

Who is the study for?
Adults with advanced solid tumors containing a specific mutation (IDH1-R132X) who have not responded to standard treatments, or cannot tolerate them. Participants must be able to take oral medication, provide a tumor tissue sample, and use effective contraception. They should have an ECOG performance status of 0 or 1, indicating they are fully active or restricted in physically strenuous activity but ambulatory.Check my eligibility
What is being tested?
The trial is testing BAY1436032's safety and the highest dose patients can tolerate without severe side effects in those with IDH1-mutant tumors. It will also look at how the body processes the drug, its impact on tumor biology (pharmacodynamics), and any signs of shrinking tumors (clinical efficacy).See study design
What are the potential side effects?
While specific side effects for BAY1436032 aren't listed here, common ones for cancer drugs include nausea, fatigue, diarrhea, blood count changes increasing infection risk; liver function issues; potential allergic reactions; and possibly heart-related complications.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My cancer has an IDH1-R132X mutation.
Select...
I can provide a tissue sample from my tumor before treatment starts.
Select...
I can take pills and follow the study's schedule and procedures.
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I am fully active or restricted in physically strenuous activity but can do light work.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 30 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 30 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Maximum tolerated dose (MTD) of BAY1436032
Number of participants with adverse events as a measure of safety and tolerability of BAY1436032
Recommended Phase II Dose (RP2D) of BAY1436032
Secondary outcome measures
AUC(0-12) of BAY1436032
AUC(0-12)md of BAY1436032
AUC(0-24) of BAY1436032
+7 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: BAY1436032Experimental Treatment1 Intervention
Dose escalation: Patients with any type of IDH1-R132X-mutant solid tumor may be eligible for enrollment. A minimum of 3 patients per cohort will be treated. If dose limiting toxicities (DLTs) occur, Bayesian dose-DLT modeling will be performed to help guide dosing decisions and to identify the maximum tolerated dose (MTD). If the MTD is not reached, a recommended phase II dose (RP2D) will be chosen based on available safety, tolerability, PK, PD and clinical efficacy data. Dose expansion: The dose and schedule that was determined to be most appropriate in the dose escalation part of the study, which may be the MTD and / or the RP2D, will be used. Cohorts will consist of patients with the following IDH-R132X-mutant tumor types: (1) anaplastic glioma; (2) glioblastoma; (3) intrahepatic cholangiocarcinoma; (4) tumor types other than those in Cohorts 1-3.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
BAY1436032
2017
Completed Phase 1
~30

Find a Location

Who is running the clinical trial?

BayerLead Sponsor
2,237 Previous Clinical Trials
25,326,897 Total Patients Enrolled
Bayer Study DirectorStudy DirectorBayer
1,180 Previous Clinical Trials
4,261,858 Total Patients Enrolled

Media Library

BAY1436032 (Small Molecule Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT02746081 — Phase 1
Solid Tumors Research Study Groups: BAY1436032
Solid Tumors Clinical Trial 2023: BAY1436032 Highlights & Side Effects. Trial Name: NCT02746081 — Phase 1
BAY1436032 (Small Molecule Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02746081 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many healthcare settings are conducting this research experiment?

"This trial is taking place at 4 distinct sites, located in Houston, Charlottesville, and Los Angeles plus another locale. To reduce the need for travel during participation it would be best to pick the site nearest your location."

Answered by AI

Are there any open slots remaining for enrollment in this clinical exploration?

"The clinicaltrials.gov portal shows that this trial is not presently recruiting participants, despite having been first posted on 26th May 2016 and last updated on 31st October 2022. However, there are over 2,500 other trials actively seeking applicants right now."

Answered by AI

What is the regulatory status of BAY1436032?

"Due to the limited data regarding BAY1436032's efficacy and safety, our team at Power has rated this medication a 1 on a scale from 1 to 3."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Phase I Study of BAY1436032 in IDH1-mutant Advanced Solid Tumors
2016. "Phase I Study of BAY1436032 in IDH1-mutant Advanced Solid Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02746081.
~9 spots leftby Apr 2025
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