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NCT01396499 · ClinicalTrials.gov registry record · Phase 1
Study to Assess Safety, Tolerability and Preliminary Efficacy of BKM120, PI3K Kinase Inhibitor, With Advanced Leukemias
A Phase 1 study of Leukemia, sponsored by M.D. Anderson Cancer Center.
- Completed
- Registry status
- Phase 1
- Development phase
- 16
- Enrollment target
- 1
- Study location
NCT01396499: Completed Phase 1 study of Leukemia, sponsored by M.D. Anderson Cancer Center.
NCT01396499 is a Phase 1 study of Leukemia that has completed, run by M.D. Anderson Cancer Center. The registered enrollment target is 16 participants, below the 487-participant average among 233 other Leukemia trials with a reported enrollment target (97% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01396499, a Phase 1 study of Leukemia, has completed, sponsored by M.D. Anderson Cancer Center.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 16 participants
- Enrollment target
- 1
- Study location
Study Summary
The goal of this clinical research study is to find the highest tolerable dose of BKM120 that can be given to patients with relapsed or refractory leukemia. The safety of BKM120 will also be studied.
Primary Outcome
Maximum tolerated dose (MTD) defined as highest dose in which 1/6 or less subjects experience a dose limiting toxicity (DLT) during the first course of treatment. Toxicity assessed using the NCI Common Toxicity Criteria for Adverse Events, version 4.0.
Conditions Studied
Interventions
- DRUG BKM120
Study Locations (1)
Texas
- University of Texas MD Anderson Cancer Center - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2012-07 |
| Est. Completion | 2016-10 |
| Phase | Phase 1 |
What the finished NCT01396499 record still lists
NCT01396499 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 16 participants, a relatively small participant target, below the 487-participant average among 233 other Leukemia trials with a reported enrollment target (97% lower).
The record links to 1 condition, with Leukemia appearing as the primary indexed condition, and to 1 intervention - of which BKM120 is the first listed.
NCT01396499 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT01396499 about?
NCT01396499 is a clinical study titled "Study to Assess Safety, Tolerability and Preliminary Efficacy of BKM120, PI3K Kinase Inhibitor, With Advanced Leukemias". The goal of this clinical research study is to find the highest tolerable dose of BKM120 that can be given to patients with relapsed or refractory leukemia. The safety of BKM120 will also be studied.
What is the current status of trial NCT01396499?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 16 participants. The study started on 2012-07. Estimated completion is 2016-10.
What conditions does trial NCT01396499 study?
This clinical trial studies the following conditions: Leukemia.
What interventions are being tested in trial NCT01396499?
The interventions under investigation include: BKM120 (DRUG).
Who is sponsoring clinical trial NCT01396499?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01396499 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01396499's enrollment target sits among peer trials
16 195th of 233 higher than 31 of 233 other Leukemia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Leukemia 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.
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