Safety Study of the Combination of Tandutinib With Temozolomide and Bevacizumab After Radiation and Temozolomide in Patients With Newly Diagnosed With Glioblastoma Multiforme

• Sponsor: Millennium Pharmaceuticals, Inc. (Industry)
• Overall Status: Withdrawn
• CT.gov ID: NCT00904852
• Collaborator: (none)
• Enrollment: 30
• Arm: 1
• Duration (Months): 12

Study Details

Study Description

Brief Summary

This is a safety study of tandutinib in combination with temozolomide and bevacizumab after people have received radiation therapy and temozolomide treatment. This study will determine the maximum safe dose of tandutinib when combined with temozolomide and bevacizumab and evaluate the safety of the combination treatment.

Condition or Disease	Intervention/Treatment	Phase
Glioblastoma Multiforme	Drug: Tandutinib, bevacizumab, and temozolomide	Phase 1

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 30 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Phase 1, Multicenter, Open-Label, Dose Escalation Study of Tandutinib (Formerly MLN518) in Combination With Temozolomide and Bevacizumab Following Concurrent Radiation Therapy and Temozolomide in the Treatment of Patients With Newly Diagnosed Glioblastoma Multiforme.
• Study Start Date: Jun 1, 2009
• Anticipated Primary Completion Date: May 1, 2010
• Anticipated Study Completion Date: Jun 1, 2010

Arms and Interventions

Arm

Intervention/Treatment

Experimental: Tandutinib, bevacizumab, and temozolomide tandutinib in combination with temozolomide and bevacizumab following concurrent radiation therapy and temozolomide treatment.

Drug: Tandutinib, bevacizumab, and temozolomide; All patients will have completed treatment with concurrent radiation therapy and temozolomide. Patients will be entered into different dosing groups of tandutinib. Patients will receive up to 6 cycles of treatment with oral temozolomide at 150 mg/m2 daily for the first 5 days of a 28 day cycle, oral tandutinib at escalating doses 250, 375, 500, or 625 mg twice daily on days 1 to 28, and intravenous bevacizumab at 10 mg/kg on days 1 and 15 of each cycle

Outcome Measures

Primary Outcome Measures

1. Maximum tolerated dose of tandutinib, adverse events, serious adverse events and dose limiting toxicities, clinical laboratory values and vital sign measurements [Cycle 1 days 1, 8, 15, and 22. Cycle 2 -6 days 1 and 15]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Diagnosis of glioblastoma multiforme

• Received radiotherapy for glioblastoma multiforme

• Patients who have not had previous treatments for glioblastoma multiforme (except for surgery, radiation and temozolomide therapy)

• Females that are postmenopausal for at least 1 year prior to screening visit

• 18 years of age and older

Exclusion Criteria:

• Other brain cancers that are not diagnosed as glioblastoma multiforme

• female patients who are lactating or are pregnant

• HIV positive and/or any other active infection requiring therapy

• Known hepatitis B or hepatitis C infection

• Diagnosed or treated any other cancer within 2 years before the first dose

• History of cardiovascular conditions and/or vascular disease

• Allergic to any component of bevacizumab

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Millennium Pharmaceuticals, Inc.

Investigators

• Study Director: Sudha Parasuraman, MD, Millennium Pharmaceuticals, Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00904852
• Other Study ID Numbers: C03003
• First Posted: May 20, 2009
• Last Update Posted: May 20, 2009
• Last Verified: May 1, 2009

• Additional relevant MeSH terms: Glioblastoma; Bevacizumab; Temozolomide

Study Results

No Results Posted as of May 20, 2009