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NCT03127735 · ClinicalTrials.gov registry record · Phase 1

BAY1436032 in Patients With Mutant IDH1(mIDH1) Advanced Acute Myeloid Leukemia (AML)

A Phase 1 study, sponsored by Bayer.

Completed
Registry status
Phase 1
Development phase
27
Enrollment target

NCT03127735 is a Phase 1 study that has completed, run by Bayer. The registered enrollment target is 27 participants.

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The verdict

NCT03127735, a Phase 1 study, has completed, sponsored by Bayer.

COMPLETED
Registry status
Phase 1
Development phase
27 participants
Enrollment target

Study Summary

To determine the maximum tolerated and / or recommended Phase II dose of oral mutant IDH1 (mIDH1) inhibitor BAY1436032 and to characterize its safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary clinical efficacy in patients with mIDH1-R132X advanced acute myeloid leukemia (AML)

Interventions

  • DRUG BAY1436032

Trial Details

FieldValue
Enrollment Target 27 participants
Start Date 2017-06-14
Est. Completion 2019-03-15
Phase Phase 1

Sponsor

Bayer

591 total trials

What the Registry Record Tells You About NCT03127735

The ClinicalTrials.gov registry entry for NCT03127735 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 27 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Bayer, which has 591 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 1 intervention - of which BAY1436032 is the first listed.

NCT03127735 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT03127735 about?

NCT03127735 is a clinical study titled "BAY1436032 in Patients With Mutant IDH1(mIDH1) Advanced Acute Myeloid Leukemia (AML)". To determine the maximum tolerated and / or recommended Phase II dose of oral mutant IDH1 (mIDH1) inhibitor BAY1436032 and to characterize its safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary clinical efficacy in patients with mIDH1-R132X advanced acute myeloid leukemia (AML...

What is the current status of trial NCT03127735?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 27 participants. The study started on 2017-06-14. Estimated completion is 2019-03-15.

What interventions are being tested in trial NCT03127735?

The interventions under investigation include: BAY1436032 (DRUG).

Who is sponsoring clinical trial NCT03127735?

This trial is sponsored by Bayer, which has 591 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.