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NCT00919035 · ClinicalTrials.gov registry record · Phase 2
Single Agent Temsirolimus (Torisel®) in Chemotherapy-naïve Castration-Resistant Prostate Cancer Patients
A Phase 2 study, sponsored by Oncology Specialists, S.C..
- Completed
- Registry status
- Phase 2
- Development phase
- 21
- Enrollment target
NCT00919035: Completed Phase 2 study, sponsored by Oncology Specialists, S.C..
NCT00919035 is a Phase 2 study that has completed, run by Oncology Specialists, S.C.. The registered enrollment target is 21 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (84% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00919035, a Phase 2 study, has completed, sponsored by Oncology Specialists, S.C..
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 21 participants
- Enrollment target
Study Summary
This is a single institution, open label, phase II study in androgen-independent prostate cancer patients who are chemotherapy-naïve. Patients will receive Torisel® 25 mg weekly. Treatment continues until disease progression, patient's withdrawal, unacceptable toxicity or the investigator's discretion.
Primary Outcome
The overall clinical benefit is defined as the sum of complete response (CR), partial response (PR), and stable disease (SD). CR: is the disappearance of all measurable lesions including bone lesions detected on the bone scan, no evidence of new lesions, and no disease-related symptoms. PR: More than 30% decrease in the sum of longest diameter of measurable lesions compared to baseline. SD: Lesions should have no sufficient decrease for PR or CR and no sufficient increase to meet criteria for Pr
Interventions
- DRUG torisel
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 21 participants |
| Start Date | 2009-06 |
| Est. Completion | 2013-10 |
| Phase | Phase 2 |
What the finished NCT00919035 record still lists
NCT00919035 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 21 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (84% lower).
The record links to 0 conditions, and to 1 intervention - of which torisel is the first listed.
NCT00919035 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00919035 about?
NCT00919035 is a clinical study titled "Single Agent Temsirolimus (Torisel®) in Chemotherapy-naïve Castration-Resistant Prostate Cancer Patients". This is a single institution, open label, phase II study in androgen-independent prostate cancer patients who are chemotherapy-naïve. Patients will receive Torisel® 25 mg weekly. Treatment continues until disease progression, patient's withdrawal, unacceptable toxicity or the investigator's discreti...
What is the current status of trial NCT00919035?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 21 participants. The study started on 2009-06. Estimated completion is 2013-10.
What interventions are being tested in trial NCT00919035?
The interventions under investigation include: torisel (DRUG).
Who is sponsoring clinical trial NCT00919035?
This trial is sponsored by Oncology Specialists, S.C., which has 10 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00919035's enrollment target sits among peer trials
21 1794th of 2000 higher than 196 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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