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NCT02323113 · ClinicalTrials.gov registry record · Phase 1
Safety, Tolerability, and Efficacy of TAK-659 in Adults With Relapsed or Refractory Acute Myelogenous Leukemia (AML)
A Phase 1 study, sponsored by Calithera Biosciences.
- Terminated
- Registry status
- Phase 1
- Development phase
- 43
- Enrollment target
NCT02323113: Clinical Trial Phase 1 study, sponsored by Calithera Biosciences.
NCT02323113 is a Phase 1 study that was terminated before completion, run by Calithera Biosciences. The registered enrollment target is 43 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (28% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02323113, a Phase 1 study, was terminated before completion, sponsored by Calithera Biosciences.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 43 participants
- Enrollment target
Study Summary
The purpose of the Phase 1b dose finding phase is to determine the safety, tolerability, and maximum tolerated dose (MTD)/recommended phase 2 dose (RP2D) of TAK-659 in participants with relapsed or refractory AML. The purpose of the Phase 2 expansion phase is to evaluate preliminary efficacy of TAK-659 in relapsed or refractory AML as measured by overall response rate (ORR).
Primary Outcome
AE meant any untoward medical occurrence in a participant or participant administered a pharmaceutical product; the untoward medical occurrence did not necessarily have a causal relationship with this treatment. SAE is any untoward medical occurrence that at any dose may result in death, life-threatening, required in participant hospitalization or prolongation of an existing hospitalization or can be a medically important event. TEAEs were defined as any AE that occurs after administration of th
Interventions
- DRUG TAK-659
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 43 participants |
| Start Date | 2015-03-09 |
| Est. Completion | 2018-08-15 |
| Phase | Phase 1 |
Why NCT02323113 stopped before completion
NCT02323113 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 43 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (28% lower).
The record links to 0 conditions, and to 1 intervention - of which TAK-659 is the first listed.
NCT02323113 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02323113 about?
NCT02323113 is a clinical study titled "Safety, Tolerability, and Efficacy of TAK-659 in Adults With Relapsed or Refractory Acute Myelogenous Leukemia (AML)". The purpose of the Phase 1b dose finding phase is to determine the safety, tolerability, and maximum tolerated dose (MTD)/recommended phase 2 dose (RP2D) of TAK-659 in participants with relapsed or refractory AML. The purpose of the Phase 2 expansion phase is to evaluate preliminary efficacy of TAK-...
What is the current status of trial NCT02323113?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 43 participants. The study started on 2015-03-09. Estimated completion is 2018-08-15.
What interventions are being tested in trial NCT02323113?
The interventions under investigation include: TAK-659 (DRUG).
Who is sponsoring clinical trial NCT02323113?
This trial is sponsored by Calithera Biosciences, which has 22 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02323113's enrollment target sits among peer trials
43 1100th of 2000 higher than 896 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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