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NCT00541866 · ClinicalTrials.gov registry record · Phase 1
Safety and Tolerability Study of Voreloxin and Cytarabine Combination in Acute Myeloid Leukemia in Humans
A Phase 1 study of Acute Myeloid Leukemia, sponsored by Sunesis Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 110
- Enrollment target
- 9
- Study locations
NCT00541866: Completed Phase 1 study of Acute Myeloid Leukemia, sponsored by Sunesis Pharmaceuticals.
NCT00541866 is a Phase 1 study of Acute Myeloid Leukemia that has completed, run by Sunesis Pharmaceuticals. The registered enrollment target is 110 participants, roughly in line with the 115-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target. The trial reports 9 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00541866, a Phase 1 study of Acute Myeloid Leukemia, has completed, sponsored by Sunesis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 110 participants
- Enrollment target
- 9
- Study locations
Study Summary
This study will evaluate the safety and tolerability of voreloxin (vosaroxin) injection in combination with cytarabine in patients with relapsed or refractory acute myeloid leukemia.
Primary Outcome
Patients were treated in cohorts with escalating doses of vosaroxin administered in combination with cytarabine in Schedule A, and with vosaroxin in escalating doses in Schedule B. For both Schedules, the highest dose at which fewer than 2 of 6 (\<0.33) patients experienced a dose-limiting toxicity (DLT) during induction became the MTD and the recommended future dose.
Conditions Studied
Interventions
- DRUG Voreloxin injection and cytarabine
Study Locations (9)
Colorado
- HealthOne Presbyterian/St. Luke's Medical Center - Denver
- Rocky Mountain Cancer Centers - Denver
Illinois
- Northwestern Medical Faculty Foundation - Chicago
- Northwestern Memorial Hospital - Chicago
Florida
- H. Lee Moffitt Cancer Center - Tampa
Indiana
- Indiana University Cancer Center - Indianapolis
Maryland
- Johns Hopkins University - Sidney Kimmel Cancer Center - Baltimore
New York
- New York Presbyterian Hospital-Weill Cornell Medical College - New York
Texas
- MD Anderson Cancer Center - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 110 participants |
| Start Date | 2007-10-06 |
| Est. Completion | 2012-02-15 |
| Phase | Phase 1 |
What the finished NCT00541866 record still lists
NCT00541866 is an interventional study that assigns participants to a tested intervention. The registered 110 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 115-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target.
The record links to 1 condition, with Acute Myeloid Leukemia appearing as the primary indexed condition, and to 1 intervention - of which Voreloxin injection and cytarabine is the first listed.
NCT00541866 lists 9 locations in 7 states (Colorado, Illinois, Florida).
Frequently Asked Questions
What is clinical trial NCT00541866 about?
NCT00541866 is a clinical study titled "Safety and Tolerability Study of Voreloxin and Cytarabine Combination in Acute Myeloid Leukemia in Humans". This study will evaluate the safety and tolerability of voreloxin (vosaroxin) injection in combination with cytarabine in patients with relapsed or refractory acute myeloid leukemia.
What is the current status of trial NCT00541866?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 110 participants. The study started on 2007-10-06. Estimated completion is 2012-02-15.
What conditions does trial NCT00541866 study?
This clinical trial studies the following conditions: Acute Myeloid Leukemia.
What interventions are being tested in trial NCT00541866?
The interventions under investigation include: Voreloxin injection and cytarabine (DRUG).
Who is sponsoring clinical trial NCT00541866?
This trial is sponsored by Sunesis Pharmaceuticals, which has 13 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00541866 being conducted?
This trial has 9 study locations across Colorado, Florida, Illinois, Indiana, Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT00541866's enrollment target sits among peer trials
110 73rd of 306 higher than 234 of 306 other Acute Myeloid Leukemia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Acute Myeloid 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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