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NCT01083368 · ClinicalTrials.gov registry record · Phase 1
Temsirolimus and Bevacizumab in Hormone-Resistant Metastatic Prostate Cancer That Did Not Respond to Chemotherapy
A Phase 1 study, sponsored by Case Comprehensive Cancer Center.
- Completed
- Registry status
- Phase 1
- Development phase
- 22
- Enrollment target
NCT01083368: Completed Phase 1 study, sponsored by Case Comprehensive Cancer Center.
NCT01083368 is a Phase 1 study that has completed, run by Case Comprehensive Cancer Center. The registered enrollment target is 22 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (63% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01083368, a Phase 1 study, has completed, sponsored by Case Comprehensive Cancer Center.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 22 participants
- Enrollment target
Study Summary
RATIONALE: Temsirolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. Giving temsirolimus together with bevacizumab may be a better way to block tumor growth. PURPOSE: This phase I/II trial is studying the side effects and best dose of temsirolimus when given together with bevacizumab and to see how well it works in treating patients with hormone-resistant metastatic prostate cancer that did not respond to chemotherapy.
Primary Outcome
Participants received temsirolimus (20mg or 25mg IV weekly) in combination with a fixed dose of IV bevacizumab (10mg/kg every 2 weeks). The MTD was determined to be the dose at which no unacceptable toxicities were observed.
Interventions
- OTHER laboratory biomarker analysis
- BIOLOGICAL bevacizumab
- GENETIC polymorphism analysis
- DRUG temsirolimus
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 22 participants |
| Start Date | 2009-01 |
| Est. Completion | 2014-10 |
| Phase | Phase 1 |
What the finished NCT01083368 record still lists
NCT01083368 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 22 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (63% lower).
The record links to 0 conditions, and to 4 interventions - of which laboratory biomarker analysis is the first listed.
NCT01083368 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01083368 about?
NCT01083368 is a clinical study titled "Temsirolimus and Bevacizumab in Hormone-Resistant Metastatic Prostate Cancer That Did Not Respond to Chemotherapy". RATIONALE: Temsirolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill the...
What is the current status of trial NCT01083368?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 22 participants. The study started on 2009-01. Estimated completion is 2014-10.
What interventions are being tested in trial NCT01083368?
The interventions under investigation include: laboratory biomarker analysis (OTHER), bevacizumab (BIOLOGICAL), polymorphism analysis (GENETIC), temsirolimus (DRUG).
Who is sponsoring clinical trial NCT01083368?
This trial is sponsored by Case Comprehensive Cancer Center, which has 407 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01083368's enrollment target sits among peer trials
22 1601st of 2000 higher than 386 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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