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NCT00065468 · ClinicalTrials.gov registry record · Phase 3

Study Evaluating Interferon And CCI-779 In Advanced Renal Cell Carcinoma

A Phase 3 study, sponsored by Pfizer.

Completed
Registry status
Phase 3
Development phase
626
Enrollment target

NCT00065468: Completed Phase 3 study, sponsored by Pfizer.

NCT00065468 is a Phase 3 study that has completed, run by Pfizer. The registered enrollment target is 626 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (19% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00065468, a Phase 3 study, has completed, sponsored by Pfizer.

COMPLETED
Registry status
Phase 3
Development phase
626 participants
Enrollment target

Study Summary

The primary objective of this study is efficacy. The primary efficacy endpoint of this study is a comparison of the overall survival of subjects treated with CCI-779 \[Temsirolimus\], administered intravenously \[IV\] once weekly and the combination of CCI-779, administered IV once weekly with Interferon Alfa \[IFN alfa\] subcutaneously \[SC\] three times per week \[TIW\], compared with the overall survival of subjects treated with IFN alfa (SC TIW) alone, in poor-prognosis subjects with advanced RCC.

Primary Outcome

Overall survival is the duration from randomization to death. For participants who are alive, overall survival is censored at the last contact.

Interventions

  • DRUG CCI-779
  • DRUG Interferon Alfa
  • DRUG Interferon Alfa and CCI-779

Trial Details

FieldValue
Enrollment Target 626 participants
Start Date 2003-07
Est. Completion 2011-03
Phase Phase 3
Pfizer

1,845 total trials

What the finished NCT00065468 record still lists

NCT00065468 is an interventional study that assigns participants to a tested intervention. The registered 626 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (19% lower).

The record links to 0 conditions, and to 3 interventions - of which CCI-779 is the first listed.

NCT00065468 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00065468 about?

NCT00065468 is a clinical study titled "Study Evaluating Interferon And CCI-779 In Advanced Renal Cell Carcinoma". The primary objective of this study is efficacy. The primary efficacy endpoint of this study is a comparison of the overall survival of subjects treated with CCI-779 \[Temsirolimus\], administered intravenously \[IV\] once weekly and the combination of CCI-779, administered IV once weekly with Inter...

What is the current status of trial NCT00065468?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 626 participants. The study started on 2003-07. Estimated completion is 2011-03.

What interventions are being tested in trial NCT00065468?

The interventions under investigation include: CCI-779 (DRUG), Interferon Alfa (DRUG), Interferon Alfa and CCI-779 (DRUG).

Who is sponsoring clinical trial NCT00065468?

This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00065468's enrollment target sits among peer trials

626 586th of 2000 higher than 1,415 of 2,000 other Phase 3 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 3 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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Source: ClinicalTrials.gov NCT00065468, the US trial registry maintained by the National Library of Medicine. NCT00065468 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.