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NCT00631371 · ClinicalTrials.gov registry record · Phase 3

Study Comparing Bevacizumab + Temsirolimus vs. Bevacizumab + Interferon-Alfa In Advanced Renal Cell Carcinoma Subjects

A Phase 3 study, sponsored by Pfizer.

Completed
Registry status
Phase 3
Development phase
791
Enrollment target

NCT00631371: Completed Phase 3 study, sponsored by Pfizer.

NCT00631371 is a Phase 3 study that has completed, run by Pfizer. The registered enrollment target is 791 participants, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00631371, a Phase 3 study, has completed, sponsored by Pfizer.

COMPLETED
Registry status
Phase 3
Development phase
791 participants
Enrollment target

Study Summary

Primary objective: Comparison of independently assessed progression free survival (PFS) in subjects administered Bevacizumab + Temsirolimus vs. those administered Bevacizumab + Interferon-Alfa. Secondary objectives: safety, Investigator assessed PFS, objective response rate (independently assessed), and overall survival.

Primary Outcome

PFS was defined as the interval from the date of randomization until the earlier date of progression or death. Progression was assessed by independent imaging reviewers using Response Evaluation Criteria in Solid Tumors (RECIST) criteria which is 20% increase in sum of longest diameter of target lesions from nadir (the lowest blood counts); measurable increase in non-target lesion; appearance of new lesions.

Interventions

  • DRUG Bevacizumab
  • DRUG Temsirolimus
  • DRUG Interferon-Alfa 9MU

Trial Details

FieldValue
Enrollment Target 791 participants
Start Date 2008-04
Est. Completion 2015-04
Phase Phase 3
Pfizer

1,845 total trials

What the finished NCT00631371 record still lists

NCT00631371 is an interventional study that assigns participants to a tested intervention. The registered 791 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target.

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

NCT00631371 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00631371 about?

NCT00631371 is a clinical study titled "Study Comparing Bevacizumab + Temsirolimus vs. Bevacizumab + Interferon-Alfa In Advanced Renal Cell Carcinoma Subjects". Primary objective: Comparison of independently assessed progression free survival (PFS) in subjects administered Bevacizumab + Temsirolimus vs. those administered Bevacizumab + Interferon-Alfa. Secondary objectives: safety, Investigator assessed PFS, objective response rate (independently assessed),...

What is the current status of trial NCT00631371?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 791 participants. The study started on 2008-04. Estimated completion is 2015-04.

What interventions are being tested in trial NCT00631371?

The interventions under investigation include: Bevacizumab (DRUG), Temsirolimus (DRUG), Interferon-Alfa 9MU (DRUG).

Who is sponsoring clinical trial NCT00631371?

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 NCT00631371's enrollment target sits among peer trials

791 429th of 2000 higher than 1,572 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 NCT00631371, the US trial registry maintained by the National Library of Medicine. NCT00631371 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.