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NCT02878785 · ClinicalTrials.gov registry record · Phase 1
Decitabine and Talazoparib in Untreated AML and R/R AML
A Phase 1 study, sponsored by University of Maryland, Baltimore.
- Completed
- Registry status
- Phase 1
- Development phase
- 25
- Enrollment target
NCT02878785: Completed Phase 1 study, sponsored by University of Maryland, Baltimore.
NCT02878785 is a Phase 1 study that has completed, run by University of Maryland, Baltimore. The registered enrollment target is 25 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (58% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02878785, a Phase 1 study, has completed, sponsored by University of Maryland, Baltimore.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 25 participants
- Enrollment target
Study Summary
The purpose of this study is to find the best way to combine a new chemotherapy drug with one that is already in use to treat AML. The new experimental drug is called talazoparib (also known as BMN-673), and it is not approved by the Federal Drug Administration (FDA). The FDA is allowing the use of talazoparib for the purposes of this study. Decitabine is used to treat bone marrow diseases called myelodysplastic syndromes (MDS), as well as off label for AML. Lab work suggests that talazoparib will increase the effects of decitabine in leukemia cells. Investigators hope that treating patients with decitabine and talazoparib together will be more successful that treating patients with decitabine alone. This study has two parts. The purpose of part one the study is to find out the best doses of decitabine and talazoparib to use when they are given together to treat AML. The purpose of part two is to see how well the drugs work together to treat AML. All participants in the study will be treated with decitabine and talazoparib. Part one of the study will include as few as two people and as many as 36 people to find the best dose levels of the study drugs. Part one will begin enrolling first. Part two of the study will not start until the Part one of the study is complete. Participants will be told which part of the study they may be enrolled in. Part two of the study may include as few as 79 people and as many as 135 people. Part two includes three separate arms. Participants enrolled in Part two of the study, will be assigned to one of the three arms below in order to test the success rate of the study drug dose determined by Part one: * Arm A will enroll adult patients with AML who are thought not to be likely to tolerate or respond to standard chemotherapy; * Arm B will enroll adult patients with AML that has not responded to previous treatment or has come back after responding to previous treatment; * Arm C will enroll adult patients previously treated with a
Primary Outcome
To determine the recommended Phase 2 doses of Decitabine based on numbers of participants with treatment-related adverse events, evaluated according to Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE).
Interventions
- DRUG Decitabine
- DRUG talazoparib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 25 participants |
| Start Date | 2016-08 |
| Est. Completion | 2020-11-19 |
| Phase | Phase 1 |
What the finished NCT02878785 record still lists
NCT02878785 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 25 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (58% lower).
The record links to 0 conditions, and to 2 interventions - of which Decitabine is the first listed.
NCT02878785 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02878785 about?
NCT02878785 is a clinical study titled "Decitabine and Talazoparib in Untreated AML and R/R AML". The purpose of this study is to find the best way to combine a new chemotherapy drug with one that is already in use to treat AML. The new experimental drug is called talazoparib (also known as BMN-673), and it is not approved by the Federal Drug Administration (FDA). The FDA is allowing the use of ...
What is the current status of trial NCT02878785?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 25 participants. The study started on 2016-08. Estimated completion is 2020-11-19.
What interventions are being tested in trial NCT02878785?
The interventions under investigation include: Decitabine (DRUG), talazoparib (DRUG).
Who is sponsoring clinical trial NCT02878785?
This trial is sponsored by University of Maryland, Baltimore, which has 560 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02878785's enrollment target sits among peer trials
25 1495th of 2000 higher than 481 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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