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NCT02746081 · ClinicalTrials.gov registry record · Phase 1
Phase I Study of BAY1436032 in IDH1-mutant Advanced Solid Tumors
A Phase 1 study, sponsored by Bayer.
- Completed
- Registry status
- Phase 1
- Development phase
- 81
- Enrollment target
NCT02746081 is a Phase 1 study that has completed, run by Bayer. The registered enrollment target is 81 participants.
The verdict
NCT02746081, a Phase 1 study, has completed, sponsored by Bayer.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 81 participants
- Enrollment target
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.
Interventions
- DRUG BAY1436032
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 81 participants |
| Start Date | 2016-05-26 |
| Est. Completion | 2024-12-03 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02746081
The ClinicalTrials.gov registry entry for NCT02746081 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 81 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.
NCT02746081 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02746081 about?
NCT02746081 is a clinical study titled "Phase I Study of BAY1436032 in IDH1-mutant Advanced Solid Tumors". 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: * Evalu...
What is the current status of trial NCT02746081?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 81 participants. The study started on 2016-05-26. Estimated completion is 2024-12-03.
What interventions are being tested in trial NCT02746081?
The interventions under investigation include: BAY1436032 (DRUG).
Who is sponsoring clinical trial NCT02746081?
This trial is sponsored by Bayer, which has 591 total clinical trials registered on ClinicalTrials.gov.
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