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NCT02543879 · ClinicalTrials.gov registry record · Phase 1
Study of a Novel BET Inhibitor FT-1101 in Patients With Relapsed or Refractory Hematologic Malignancies
A Phase 1 study, sponsored by Forma Therapeutics.
- Completed
- Registry status
- Phase 1
- Development phase
- 94
- Enrollment target
NCT02543879 is a Phase 1 study that has completed, run by Forma Therapeutics. The registered enrollment target is 94 participants.
The verdict
NCT02543879, a Phase 1 study, has completed, sponsored by Forma Therapeutics.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 94 participants
- Enrollment target
Study Summary
This is an open-label, multicenter, dose-escalation Phase 1/1b study in patients with acute myelogenous leukemia (AML)/MDS or non-Hodgkin Lymphoma (NHL), intended to investigate safety, pharmacokinetics, and the pharmacodynamic effects of FT-1101 administered via one or more intermittent dosing schedules alone and in combination with azacitidine. Once the MTD has been established for a treatment cohort, up to 20 additional patients may be enrolled in up to 4 expansion cohorts each of select populations of patients with either AML/MDS or NHL at the recommended dose for future studies to confirm safety.
Interventions
- DRUG Azacitidine
- DRUG FT-1101
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 94 participants |
| Start Date | 2015-09 |
| Est. Completion | 2019-03 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02543879
The ClinicalTrials.gov registry entry for NCT02543879 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 94 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Forma Therapeutics, which has 8 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Azacitidine is the first listed.
NCT02543879 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02543879 about?
NCT02543879 is a clinical study titled "Study of a Novel BET Inhibitor FT-1101 in Patients With Relapsed or Refractory Hematologic Malignancies". This is an open-label, multicenter, dose-escalation Phase 1/1b study in patients with acute myelogenous leukemia (AML)/MDS or non-Hodgkin Lymphoma (NHL), intended to investigate safety, pharmacokinetics, and the pharmacodynamic effects of FT-1101 administered via one or more intermittent dosing sche...
What is the current status of trial NCT02543879?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 94 participants. The study started on 2015-09. Estimated completion is 2019-03.
What interventions are being tested in trial NCT02543879?
The interventions under investigation include: Azacitidine (DRUG), FT-1101 (DRUG).
Who is sponsoring clinical trial NCT02543879?
This trial is sponsored by Forma Therapeutics, which has 8 total clinical trials registered on ClinicalTrials.gov.
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