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

NCT00904852 | Withdrawn Phase 1

• 1 other identifier: C03003
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Glioblastoma Multiforme

Outcome Measures

Primary Outcomes (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

Study Arms (1)

Tandutinib, bevacizumab, and temozolomide

EXPERIMENTAL

tandutinib in combination with temozolomide and bevacizumab following concurrent radiation therapy and temozolomide treatment.

Drug: Tandutinib, bevacizumab, and temozolomide

Interventions

Tandutinib, bevacizumab, and temozolomide DRUG

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

Tandutinib, bevacizumab, and temozolomide

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• years of age and older

You may not qualify if:

• 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

Sponsors & Collaborators

• Millennium Pharmaceuticals, Inc.: lead

MeSH Terms

Conditions

Glioblastoma

Interventions

tandutinib; Bevacizumab; Temozolomide

Condition Hierarchy (Ancestors)

Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Dacarbazine; Triazenes; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Sudha Parasuraman, MD

  Millennium Pharmaceuticals, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: May 19, 2009
• First Posted: May 20, 2009
• Study Start: June 1, 2009
• Primary Completion: May 1, 2010
• Study Completion: June 1, 2010
• Last Updated: May 20, 2009

Record last verified: 2009-05