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NCT00642031 · ClinicalTrials.gov registry record · Phase 1
Triciribine Phosphate Monohydrate (TCN-PM, VD-0002) in Adult Patients With Advanced Hematologic Malignancies
A Phase 1 study of Leukemia and Hematologic Malignancies, sponsored by Prescient Therapeutics.
- Completed
- Registry status
- Phase 1
- Development phase
- 20
- Enrollment target
- 2
- Study locations
NCT00642031: Completed Phase 1 study of Leukemia and Hematologic Malignancies, sponsored by Prescient Therapeutics.
NCT00642031 is a Phase 1 study of Leukemia and Hematologic Malignancies that has completed, run by Prescient Therapeutics. The registered enrollment target is 20 participants, below the 487-participant average among 233 other Leukemia trials with a reported enrollment target (96% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00642031, a Phase 1 study of Leukemia and Hematologic Malignancies, has completed, sponsored by Prescient Therapeutics.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 20 participants
- Enrollment target
- 2
- Study locations
Study Summary
Primary objective: To determine the dose limiting toxicity (DLT) and maximum tolerated dose (MTD) of TCN-PM (Triciribine) when administered as an approximately one-hour intravenous infusion on a weekly schedule on days 1, 8 and 15 in a 28 day cycle in patients with advanced hematologic malignancies; To determine the pharmacokinetics (PK) of Triciribine following study drug administration. Secondary objective: To observe the anti-tumor effects of Triciribine, if any occur
Primary Outcome
The MTD is the highest dose level in which \<2 patients of 6 develop first cycle dose-limiting toxicity (DLT). Evaluations after each dose level (28 day cycle).
Conditions Studied
Interventions
- DRUG Triciribine
Study Locations (2)
Florida
- H. Lee Moffitt Cancer Center - Tampa
Texas
- UT MD Anderson Cancer Center - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2006-08 |
| Est. Completion | 2012-10 |
| Phase | Phase 1 |
What the finished NCT00642031 record still lists
NCT00642031 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 487-participant average among 233 other Leukemia trials with a reported enrollment target (96% lower).
The record links to 2 conditions, with Leukemia appearing as the primary indexed condition, and to 1 intervention - of which Triciribine is the first listed.
NCT00642031 reports a single indexed study location in Florida, Texas.
Frequently Asked Questions
What is clinical trial NCT00642031 about?
NCT00642031 is a clinical study titled "Triciribine Phosphate Monohydrate (TCN-PM, VD-0002) in Adult Patients With Advanced Hematologic Malignancies". Primary objective: To determine the dose limiting toxicity (DLT) and maximum tolerated dose (MTD) of TCN-PM (Triciribine) when administered as an approximately one-hour intravenous infusion on a weekly schedule on days 1, 8 and 15 in a 28 day cycle in patients with advanced hematologic malignancies...
What is the current status of trial NCT00642031?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 20 participants. The study started on 2006-08. Estimated completion is 2012-10.
What conditions does trial NCT00642031 study?
This clinical trial studies the following conditions: Leukemia, Hematologic Malignancies.
What interventions are being tested in trial NCT00642031?
The interventions under investigation include: Triciribine (DRUG).
Who is sponsoring clinical trial NCT00642031?
This trial is sponsored by Prescient Therapeutics, which has 6 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00642031 being conducted?
This trial has 2 study locations across Florida, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT00642031's enrollment target sits among peer trials
20 185th of 233 higher than 42 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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