Status:
COMPLETED
Temozolomide All-Case-Registered Surveillance (Designated Drug Use Investigation)(Study P05062)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Glioma
Astrocytoma
Eligibility:
All Genders
Brief Summary
The purpose of this study is to confirm the safety and efficacy of temozolomide in patients with newly diagnosed malignant glioma (concomitant with radiotherapy and then as monotherapy) and relapsed m...
Detailed Description
Patients are invited to participate in the study.
Eligibility Criteria
Inclusion
- All patients treated with temozolomide for newly diagnosed malignant glioma (concomitant with radiotherapy and then as monotherapy) and relapsed malignant glioma (as monotherapy).
Exclusion
- Patients with a history of hypersensitivity to temozolomide or dacarbazine.
- Pregnant women and women who may be pregnant.
Key Trial Info
Start Date :
September 1 2006
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 1 2016
Estimated Enrollment :
1804 Patients enrolled
Trial Details
Trial ID
NCT00705198
Start Date
September 1 2006
End Date
July 1 2016
Last Update
November 15 2016
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