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NCT00629343 · ClinicalTrials.gov registry record · Phase 1
Phase I Dose-Escalation Study Of Azacitidine In Combination With Temozolomide
A Phase 1 study of Soft Tissue Sarcoma and Mesothelioma, sponsored by Columbia University.
- Completed
- Registry status
- Phase 1
- Development phase
- 27
- Enrollment target
- 1
- Study location
NCT00629343: Completed Phase 1 study of Soft Tissue Sarcoma and Mesothelioma, sponsored by Columbia University.
NCT00629343 is a Phase 1 study of Soft Tissue Sarcoma and Mesothelioma that has completed, run by Columbia University. The registered enrollment target is 27 participants, below the 78-participant average among 55 other Soft Tissue Sarcoma trials with a reported enrollment target (65% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00629343, a Phase 1 study of Soft Tissue Sarcoma and Mesothelioma, has completed, sponsored by Columbia University.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 27 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this study is to determine safety and toxicity for the combination of Temozolomide and Azacitidine in the treatment of Advanced Soft Tissue Sarcoma or Malignant Mesothelioma. This is a single-center, open-label, single-arm Phase I dose-escalation trial. Patients will be evaluated with complete history and physical as well as laboratory studies (complete blood count, metabolic panel, liver function tests), biopsy, and imaging of all sites of measurable disease. This study will be conducted over the course of 3 years.
Primary Outcome
Maximum tolerated dose of temozolomide when used in combination with azacitidine
Conditions Studied
Interventions
- DRUG Azacitidine
- DRUG Temozolomide
Study Locations (1)
New York
- Columbia University Medical Center - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 27 participants |
| Start Date | 2007-10 |
| Est. Completion | 2012-10 |
| Phase | Phase 1 |
What the finished NCT00629343 record still lists
NCT00629343 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 27 participants, a relatively small participant target, below the 78-participant average among 55 other Soft Tissue Sarcoma trials with a reported enrollment target (65% lower).
The record links to 2 conditions, with Soft Tissue Sarcoma appearing as the primary indexed condition, and to 2 interventions - of which Azacitidine is the first listed.
NCT00629343 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT00629343 about?
NCT00629343 is a clinical study titled "Phase I Dose-Escalation Study Of Azacitidine In Combination With Temozolomide". The purpose of this study is to determine safety and toxicity for the combination of Temozolomide and Azacitidine in the treatment of Advanced Soft Tissue Sarcoma or Malignant Mesothelioma. This is a single-center, open-label, single-arm Phase I dose-escalation trial. Patients will be evaluated with...
What is the current status of trial NCT00629343?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 27 participants. The study started on 2007-10. Estimated completion is 2012-10.
What conditions does trial NCT00629343 study?
This clinical trial studies the following conditions: Soft Tissue Sarcoma, Mesothelioma.
What interventions are being tested in trial NCT00629343?
The interventions under investigation include: Azacitidine (DRUG), Temozolomide (DRUG).
Who is sponsoring clinical trial NCT00629343?
This trial is sponsored by Columbia University, which has 958 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00629343 being conducted?
This trial has 1 study location across New York. 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 NCT00629343's enrollment target sits among peer trials
27 40th of 55 higher than 15 of 55 other Soft Tissue Sarcoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Soft Tissue Sarcoma 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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