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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: Completed Phase 1 study, sponsored by Bayer.
NCT02746081 is a Phase 1 study that has completed, run by Bayer. The registered enrollment target is 81 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (35% higher). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
MTD is defined as the maximum dose at which the predicted incidence of DLTs during Cycle 1 (DLT evaluation period) is ≤25%.
Interventions
- DRUG BAY1436032
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 81 participants |
| Start Date | 2016-05-26 |
| Est. Completion | 2024-12-03 |
| Phase | Phase 1 |
What the finished NCT02746081 record still lists
NCT02746081 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 81 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (35% higher).
The record links to 0 conditions, and to 1 intervention - of which BAY1436032 is the first listed.
NCT02746081 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02746081's enrollment target sits among peer trials
81 671st of 2000 higher than 1,329 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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