Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

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.

View on ClinicalTrials.gov ↗

View your shortlist →

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

FieldValue
Enrollment Target 21 participants
Start Date 2009-06
Est. Completion 2013-10
Phase Phase 2
Oncology Specialists, S.C.

10 total trials

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.

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

Nationwide trials with similar profiles

Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.

Similar enrollment target

  • NCT02447874 · 21 participants · Phase 1

    Arginine Therapy for the Treatment of Pain in Children With Sickle Cell Disease

  • NCT03826992 · 21 participants · Phase 1

    Venetoclax Combined With Vyxeos (CPX-351) for Participants With Relapsed or Refractory Acute Leukemia

  • NCT04107077 · 21 participants · Phase 2

    Phase II Study of the Effects of Laparoscopic Hyperthermic Intraperitoneal Chemotherapy (HIPEC) in Patients With Advanced Gastric Cancer

  • NCT04158635 · 21 participants · Phase 1

    Gemcitabine, Nab-Paclitaxel, and Bosentan for the Treatment of Unresectable Pancreatic Cancer

Similar registry start date

  • NCT05988463 · started 2027-01-01 · Phase 1

    Dose-Escalation Study of Artesunate Patients With IPF

  • NCT07219706 · started 2026-12-10 · NA

    Dietary Fiber and Time Restricted Eating

  • NCT02831335 · started 2026-12-01

    Technical Development of Multi-Parametric Renocerebral MRI

  • NCT05962346 · started 2026-12 · NA

    Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia

Source: ClinicalTrials.gov NCT00919035, the US trial registry maintained by the National Library of Medicine. NCT00919035 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.