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NCT00667394 · ClinicalTrials.gov registry record · Phase 2

Tandutinib Plus Bevacizumab to Treat Recurrent Brain Tumors

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

Completed
Registry status
Phase 2
Development phase
42
Enrollment target

NCT00667394: Completed Phase 2 study, sponsored by National Cancer Institute (NCI).

NCT00667394 is a Phase 2 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 42 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (68% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00667394, a Phase 2 study, has completed, sponsored by National Cancer Institute (NCI).

COMPLETED
Registry status
Phase 2
Development phase
42 participants
Enrollment target

Study Summary

Background: In order to survive, brain tumors must have a network of blood vessels to supply it with oxygen and nutrients. The tumors produce substances that enable new blood vessels to form. Tandutinib and Bevacizumab are experimental drugs that may prevent new blood vessel formation and thereby slow or stop tumor growth in the brain. Objectives: To determine the safety and side effects of Tandutinib in combination with Bevacizumab in patients with brain tumors. To evaluate the response of brain tumors to treatment with Tandutinib and Bevacizumab. Eligibility: Patients 18 years of age and older with a malignant brain tumor for whom standard treatments (surgery, radiation and chemotherapy) are no longer effective. Design: Patients receive treatment in 4-week cycles as follows: Tandutinib by mouth twice a day every day and intravenous (through a vein) infusions of Bevacizumab over 90 minutes (or less if well tolerated) every 2 weeks. Treatment may continue for up to 1 year, and possibly longer, as long as there are no signs of tumor growth or serious treatment side effects. Patients are evaluated with magnetic resonance imaging (MRI), computed tomography (CT) and positron emission tomography (PET) scans before starting treatment and then periodically to determine the response to treatment. Patients have physical and neurological examinations every 4 weeks and blood tests every 2 weeks. They complete quality of life questionnaires every 4 weeks.

Primary Outcome

Percentage of participants with progression free survival at 6 months. Progression is defined as a 25% increase in the sum of all measurable lesions (or two largest lesions if too numerous) over the smallest sum observed (over baseline if no decrease), clear worsening of any evaluable disease, appearance of any new lesion/site, or failure to return for evaluation due to death or deteriorating condition (unless clearly unrelated to this cancer).

Interventions

  • BIOLOGICAL Bevacizumab
  • PROCEDURE Quality-of-life assessment
  • DRUG MLN-518 (Tandutinib)

Trial Details

FieldValue
Enrollment Target 42 participants
Start Date 2008-04
Est. Completion 2011-07
Phase Phase 2
National Cancer Institute (NCI)

3,257 total trials

What the finished NCT00667394 record still lists

NCT00667394 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 42 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (68% lower).

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

NCT00667394 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00667394 about?

NCT00667394 is a clinical study titled "Tandutinib Plus Bevacizumab to Treat Recurrent Brain Tumors". Background: In order to survive, brain tumors must have a network of blood vessels to supply it with oxygen and nutrients. The tumors produce substances that enable new blood vessels to form. Tandutinib and Bevacizumab are experimental drugs that may prevent new blood vessel formation and thereby ...

What is the current status of trial NCT00667394?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 42 participants. The study started on 2008-04. Estimated completion is 2011-07.

What interventions are being tested in trial NCT00667394?

The interventions under investigation include: Bevacizumab (BIOLOGICAL), Quality-of-life assessment (PROCEDURE), MLN-518 (Tandutinib) (DRUG).

Who is sponsoring clinical trial NCT00667394?

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 NCT00667394's enrollment target sits among peer trials

42 1339th of 2000 higher than 649 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 NCT00667394, the US trial registry maintained by the National Library of Medicine. NCT00667394 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.