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This study has been withdrawn prior to enrollment.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

Tracking Information

First Received Date ^ICMJE

May 19, 2009

Last Updated Date

May 19, 2009

Start Date ^ICMJE

June 2009

Estimated Primary Completion Date

May 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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.

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 1

Study Design ^ICMJE

Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Glioblastoma Multiforme

Intervention ^ICMJE

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

Study Arm (s)

Experimental: Tandutinib, bevacizumab, and temozolomide

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

Intervention: Drug: Tandutinib, bevacizumab, and temozolomide

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Withdrawn

Estimated Enrollment ^ICMJE

Estimated Completion Date

June 2010

Estimated Primary Completion Date

May 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Not Provided

Administrative Information

NCT Number ^ICMJE

NCT00904852

Other Study ID Numbers ^ICMJE

C03003

Has Data Monitoring Committee

Responsible Party

Anthony Boral, Vice President Clinical Research, Millennium Pharmaceuticals, Inc.

Study Sponsor ^ICMJE

Millennium Pharmaceuticals, Inc.

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Sudha Parasuraman, MD

Millennium Pharmaceuticals, Inc.

Information Provided By

Millennium Pharmaceuticals, Inc.

Verification Date

May 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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