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NCT00329719 · ClinicalTrials.gov registry record · Phase 1
Sorafenib Tosylate and Temsirolimus in Treating Patients With Recurrent Glioblastoma
A Phase 1 study, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 1
- Development phase
- 115
- Enrollment target
NCT00329719: Completed Phase 1 study, sponsored by National Cancer Institute (NCI).
NCT00329719 is a Phase 1 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 115 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (92% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00329719, a Phase 1 study, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 115 participants
- Enrollment target
Study Summary
This phase I/II trial studies the side effects and best dose of temsirolimus when given together with sorafenib tosylate and to see how well they work in treating patients with glioblastoma that has come back. Sorafenib tosylate may stop the growth of tumor cells by blocking blood flow to the tumor. Drugs used in chemotherapy, such as temsirolimus, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Sorafenib tosylate and temsirolimus may also stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving sorafenib tosylate with temsirolimus may kill more tumor cells.
Primary Outcome
The primary endpoint is the proportion of patients alive and progression-free 6 months after study treatment initiation. If more than 41 evaluable patients are accrued in group 1 or group 3, the additional patients will not be used to evaluate the decision rule for that group or otherwise used in any decision-making processes. However, they will be included in the final point and confidence interval estimates for that group. The 'success' probability, i.e., 6-month progression-free survival pe
Interventions
- OTHER Laboratory Biomarker Analysis
- PROCEDURE Conventional Surgery
- DRUG Temsirolimus
- DRUG Sorafenib Tosylate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 115 participants |
| Start Date | 2006-03-24 |
| Est. Completion | 2013-02-02 |
| Phase | Phase 1 |
What the finished NCT00329719 record still lists
NCT00329719 is an interventional study that assigns participants to a tested intervention. The registered 115 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (92% higher).
The record links to 0 conditions, and to 4 interventions - of which Laboratory Biomarker Analysis is the first listed.
NCT00329719 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00329719 about?
NCT00329719 is a clinical study titled "Sorafenib Tosylate and Temsirolimus in Treating Patients With Recurrent Glioblastoma". This phase I/II trial studies the side effects and best dose of temsirolimus when given together with sorafenib tosylate and to see how well they work in treating patients with glioblastoma that has come back. Sorafenib tosylate may stop the growth of tumor cells by blocking blood flow to the tumor....
What is the current status of trial NCT00329719?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 115 participants. The study started on 2006-03-24. Estimated completion is 2013-02-02.
What interventions are being tested in trial NCT00329719?
The interventions under investigation include: Laboratory Biomarker Analysis (OTHER), Conventional Surgery (PROCEDURE), Temsirolimus (DRUG), Sorafenib Tosylate (DRUG).
Who is sponsoring clinical trial NCT00329719?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00329719's enrollment target sits among peer trials
115 504th of 2000 higher than 1,494 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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