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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 is a Phase 1 study that was terminated before completion, run by Bayer. The registered enrollment target is 8 participants.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02369029
The ClinicalTrials.gov registry entry for NCT02369029 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 8 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 BAY 1238097 is the first listed.
NCT02369029 reports 0 study locations.
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.
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