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

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by:
Millennium Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT00904852
First received: May 19, 2009
Last updated: NA
Last verified: May 2009
History: No changes posted
  Purpose

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 Intervention Phase
Glioblastoma Multiforme
Drug: Tandutinib, bevacizumab, and temozolomide
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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.

Resource links provided by NLM:


Further study details as provided by Millennium Pharmaceuticals, Inc.:

Primary Outcome Measures:
  • Maximum tolerated dose of tandutinib, adverse events, serious adverse events and dose limiting toxicities, clinical laboratory values and vital sign measurements [ Time Frame: Cycle 1 days 1, 8, 15, and 22. Cycle 2 -6 days 1 and 15 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 30
Study Start Date: June 2009
Estimated Study Completion Date: June 2010
Estimated Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00904852

Sponsors and Collaborators
Millennium Pharmaceuticals, Inc.
Investigators
Study Director: Sudha Parasuraman, MD Millennium Pharmaceuticals, Inc.
  More Information

No publications provided

Responsible Party: Anthony Boral, Vice President Clinical Research, Millennium Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT00904852     History of Changes
Other Study ID Numbers: C03003
Study First Received: May 19, 2009
Last Updated: May 19, 2009
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Glioblastoma
Astrocytoma
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Bevacizumab
Temozolomide
Dacarbazine
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Growth Inhibitors
Antineoplastic Agents
Therapeutic Uses
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 18, 2014