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NCT02369029 · ClinicalTrials.gov registry record · Phase 1
BAY1238097, First in Man
A Phase 1 study, sponsored by Bayer.
- Terminated
- Registry status
- Phase 1
- Development phase
- 8
- Enrollment target
NCT02369029: Clinical Trial Phase 1 study, sponsored by Bayer.
NCT02369029 is a Phase 1 study that was terminated before completion, run by Bayer. The registered enrollment target is 8 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (87% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02369029, a Phase 1 study, was terminated before completion, sponsored by Bayer.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 8 participants
- Enrollment target
Study Summary
This is the first study where BAY1238097 is given to humans. Impact of the study is to evaluate if patients with advanced cancer show clinical benefit under the treatment with BET(Bromodomain and extraterminal domain family ) inhibitor.Patients with solid tumors (all comers) and lymphoma will receive the study drug treatment in an escalation scheme (no placebo group) to determine the safety, tolerability and maximum tolerated dose (MTD) of BAY1238097. the relative bioavailability of Liquid Service Formulation and tablets will be determined After MTD is defined, patients with solid tumors (all comer, hepato cellular carcinoma, lung cancer, NUT(nuclear protein in testis)-midline carcinoma), melanoma and lymphoma will be enrolled A separate escalation scheme will be applied to patients with leucemias, and at the maximal tolerated dose, patients with AML amd multiple myeloma will be enrolled. the study will also assess the pharmacokinetics, biomarker status, pharmacodynamic parameters of BAY1238097 and tumor response to the treatment. BAY1238097 will be given twice weekly as oral application. Treatment will be stopped if the tumor continues to grow, if side effects occur, wich the patient cannot tolerate or if the patient decides to withdraw from the treatment.
Interventions
- DRUG BAY 1238097
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 8 participants |
| Start Date | 2015-03 |
| Est. Completion | 2016-01 |
| Phase | Phase 1 |
Why NCT02369029 stopped before completion
NCT02369029 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 8 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (87% lower).
The record links to 0 conditions, and to 1 intervention - of which BAY 1238097 is the first listed.
NCT02369029 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02369029 about?
NCT02369029 is a clinical study titled "BAY1238097, First in Man". This is the first study where BAY1238097 is given to humans. Impact of the study is to evaluate if patients with advanced cancer show clinical benefit under the treatment with BET(Bromodomain and extraterminal domain family ) inhibitor.Patients with solid tumors (all comers) and lymphoma will receiv...
What is the current status of trial NCT02369029?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 8 participants. The study started on 2015-03. Estimated completion is 2016-01.
What interventions are being tested in trial NCT02369029?
The interventions under investigation include: BAY 1238097 (DRUG).
Who is sponsoring clinical trial NCT02369029?
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 NCT02369029's enrollment target sits among peer trials
8 1959th of 2000 higher than 29 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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