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NCT00433381 · ClinicalTrials.gov registry record · Phase 2

Bevacizumab and Irinotecan or Temozolomide in Treating Patients With Recurrent or Refractory Glioblastoma Multiforme or Gliosarcoma

A Phase 2 study, sponsored by National Cancer Institute (NCI).

Completed
Registry status
Phase 2
Development phase
123
Enrollment target

NCT00433381: Completed Phase 2 study, sponsored by National Cancer Institute (NCI).

NCT00433381 is a Phase 2 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 123 participants, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00433381, a Phase 2 study, has completed, sponsored by National Cancer Institute (NCI).

COMPLETED
Registry status
Phase 2
Development phase
123 participants
Enrollment target

Study Summary

This randomized phase II trial is studying the side effects and how well giving bevacizumab together with irinotecan or temozolomide works in treating patients with recurrent or refractory glioblastoma multiforme or gliosarcoma. 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. Drugs used in chemotherapy, such as irinotecan and temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving bevacizumab together with irinotecan or temozolomide may kill more tumor cells.

Primary Outcome

Progression defined as ≥ 25% increase in the size of enhancing tumor or any new tumor; or neurologically worse, and steroids stable or increased. Percentage is calculated by taking the number of patients who have survived 6 months without progression of study disease after study registration in the numerator. The denominator consists of all patients except those who were found retrospectively to be ineligible or who were lost to follow-up after less than 6 months.

Interventions

  • DRUG Temozolomide
  • BIOLOGICAL Bevacizumab
  • DRUG Irinotecan Hydrochloride

Trial Details

FieldValue
Enrollment Target 123 participants
Start Date 2007-03-01
Est. Completion 2011-02-16
Phase Phase 2
National Cancer Institute (NCI)

3,257 total trials

What the finished NCT00433381 record still lists

NCT00433381 is an interventional study that assigns participants to a tested intervention. The registered 123 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target.

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

NCT00433381 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00433381 about?

NCT00433381 is a clinical study titled "Bevacizumab and Irinotecan or Temozolomide in Treating Patients With Recurrent or Refractory Glioblastoma Multiforme or Gliosarcoma". This randomized phase II trial is studying the side effects and how well giving bevacizumab together with irinotecan or temozolomide works in treating patients with recurrent or refractory glioblastoma multiforme or gliosarcoma. Monoclonal antibodies, such as bevacizumab, can block tumor growth in d...

What is the current status of trial NCT00433381?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 123 participants. The study started on 2007-03-01. Estimated completion is 2011-02-16.

What interventions are being tested in trial NCT00433381?

The interventions under investigation include: Temozolomide (DRUG), Bevacizumab (BIOLOGICAL), Irinotecan Hydrochloride (DRUG).

Who is sponsoring clinical trial NCT00433381?

This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00433381's enrollment target sits among peer trials

123 564th of 2000 higher than 1,436 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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Source: ClinicalTrials.gov NCT00433381, the US trial registry maintained by the National Library of Medicine. NCT00433381 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.