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NCT00335764 · ClinicalTrials.gov registry record · Phase 1
Sorafenib Combined With Erlotinib, Tipifarnib, or Temsirolimus in Treating Patients With Recurrent Glioblastoma Multiforme or Gliosarcoma
A Phase 1 study, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 1
- Development phase
- 92
- Enrollment target
NCT00335764: Completed Phase 1 study, sponsored by National Cancer Institute (NCI).
NCT00335764 is a Phase 1 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 92 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (53% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00335764, a Phase 1 study, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 92 participants
- Enrollment target
Study Summary
This phase I/II trial is studying the side effects and best dose of erlotinib, tipifarnib, and temsirolimus when given together with sorafenib and to see how well they work in treating patients with recurrent glioblastoma multiforme or gliosarcoma. Sorafenib, erlotinib, tipifarnib, and temsirolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Sorafenib and tipifarnib may also stop the growth of tumor cells by blocking blood flow to the tumor. Giving sorafenib together with erlotinib, tipifarnib, or temsirolimus may kill more tumor cells.
Primary Outcome
DLT defined as: any grade 4 hematologic toxicity; grade 3 thrombocytopenia \> 7 days, any grade 3/4 non-hematologic toxicity (despite maximal medical therapy), any intolerable grade 2 non-hematological, ro grade 3 hematological toxicity requiring deduction during first 28 days of treatment, any toxicity resulting in delay of \>1week during first 28 days of treatment
Interventions
- DRUG erlotinib hydrochloride
- DRUG sorafenib tosylate
- DRUG tipifarnib
- DRUG temsirolimus
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 92 participants |
| Start Date | 2006-04 |
| Est. Completion | 2012-09 |
| Phase | Phase 1 |
What the finished NCT00335764 record still lists
NCT00335764 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 92 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (53% higher).
The record links to 0 conditions, and to 4 interventions - of which erlotinib hydrochloride is the first listed.
NCT00335764 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00335764 about?
NCT00335764 is a clinical study titled "Sorafenib Combined With Erlotinib, Tipifarnib, or Temsirolimus in Treating Patients With Recurrent Glioblastoma Multiforme or Gliosarcoma". This phase I/II trial is studying the side effects and best dose of erlotinib, tipifarnib, and temsirolimus when given together with sorafenib and to see how well they work in treating patients with recurrent glioblastoma multiforme or gliosarcoma. Sorafenib, erlotinib, tipifarnib, and temsirolimus ...
What is the current status of trial NCT00335764?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 92 participants. The study started on 2006-04. Estimated completion is 2012-09.
What interventions are being tested in trial NCT00335764?
The interventions under investigation include: erlotinib hydrochloride (DRUG), sorafenib tosylate (DRUG), tipifarnib (DRUG), temsirolimus (DRUG).
Who is sponsoring clinical trial NCT00335764?
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 NCT00335764's enrollment target sits among peer trials
92 625th of 2000 higher than 1,375 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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