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NCT02520011 · ClinicalTrials.gov registry record · Phase 2
Alvocidib Biomarker-driven Phase 2 AML Study
A Phase 2 study, sponsored by Sumitomo Pharma America.
- Terminated
- Registry status
- Phase 2
- Development phase
- 104
- Enrollment target
NCT02520011: Clinical Trial Phase 2 study, sponsored by Sumitomo Pharma America.
NCT02520011 is a Phase 2 study that was terminated before completion, run by Sumitomo Pharma America. The registered enrollment target is 104 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (22% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02520011, a Phase 2 study, was terminated before completion, sponsored by Sumitomo Pharma America.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 104 participants
- Enrollment target
Study Summary
The purpose of this two-stage Phase 2 study is to assess the clinical response (Complete Remission) of ACM (Alvocidib/Cytarabine/Mitoxantrone) compared to CM (Cytarabine/Mitoxantrone) treatment in refractory or relapsed AML patients with demonstrated MCL-1 dependence of ≥ 30% by mitochondrial profiling in bone marrow.
Primary Outcome
Complete Remission (CR) rate = Percentage of patients achieving CR after Cycle 1 as defined in Stage 1 by the International Working Group (IWG) Criteria and 2010 European LeukemiaNet (EN) criteria in patients with relapsed or refractory AML with MCL-1 dependence \>30% and in Stage 2 by the 2017 ELN criteria. The study was terminated in January 2020 due to a steady and marked reduction in enrollment. Thus, the efficacy endpoints could not be analyzed. As sufficient efficacy results were not avai
Interventions
- DRUG Cytarabine
- DRUG Mitoxantrone
- DRUG Alvocidib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 104 participants |
| Start Date | 2016-03-14 |
| Est. Completion | 2020-02-12 |
| Phase | Phase 2 |
Why NCT02520011 stopped before completion
NCT02520011 is an interventional study that assigns participants to a tested intervention. The registered 104 participants enrollment target is mid-sized for trials with a published cap, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (22% lower).
The record links to 0 conditions, and to 3 interventions - of which Cytarabine is the first listed.
NCT02520011 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02520011 about?
NCT02520011 is a clinical study titled "Alvocidib Biomarker-driven Phase 2 AML Study". The purpose of this two-stage Phase 2 study is to assess the clinical response (Complete Remission) of ACM (Alvocidib/Cytarabine/Mitoxantrone) compared to CM (Cytarabine/Mitoxantrone) treatment in refractory or relapsed AML patients with demonstrated MCL-1 dependence of ≥ 30% by mitochondrial profil...
What is the current status of trial NCT02520011?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 104 participants. The study started on 2016-03-14. Estimated completion is 2020-02-12.
What interventions are being tested in trial NCT02520011?
The interventions under investigation include: Cytarabine (DRUG), Mitoxantrone (DRUG), Alvocidib (DRUG).
Who is sponsoring clinical trial NCT02520011?
This trial is sponsored by Sumitomo Pharma America, which has 168 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02520011's enrollment target sits among peer trials
104 660th of 2000 higher than 1,337 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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