Temodal (Temozolomide) Post Marketing Surveillance Protocol (Study P05557AM2)

NCT ID: NCT00723827

Last Updated: 2015-01-30

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 682 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2008-03-31
• Study Completion Date: 2011-09-30

Brief Summary

The purpose of this surveillance is to evaluate the postmarketing safety and efficacy of Temodal capsule (temozolomide) under actual conditions of use, and to understand some of the following points that are in question and doubt:

• Incidence of adverse events under actual conditions of use (Serious and Nonserious Adverse Events);
• Adverse Drug Reactions not shown in the directions for use (will be stated as Unexpected Adverse Reaction);
• Adverse Event caused by misuse, abuse, or drug interactions;
• Other information concerned with safety or efficacy.

Conditions

Glioblastoma; Glioma; Astrocytoma

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

All Participants

Participants with newly diagnosed glioblastoma multiforme (treat with temozolomide \& radiotherapy) or participants with malignant glioma, such as glioblastoma multiforme or anaplastic astrocytoma, showing recurrence or progression after standard therapy (treat with temozolomide).

Temozolomide

Intervention Type: DRUG

Administration of temozolomide based on the product labeling.

Radiotherapy

Intervention Type: RADIATION

Radiotherapy given concomitantly with temozolomide for newly diagnosed glioblastoma multiforme.

Interventions

Temozolomide

Administration of temozolomide based on the product labeling.

Intervention Type: DRUG

Radiotherapy

Radiotherapy given concomitantly with temozolomide for newly diagnosed glioblastoma multiforme.

Intervention Type: RADIATION

Other Intervention Names

Temodal; Temodar; SCH 052365; MK-7365; Radiation therapy; irradiation

Eligibility Criteria

Inclusion Criteria

• Participants who are prescribed with temozolomide by local labeling:

• participants with newly diagnosed glioblastoma multiforme;
• participants with malignant glioma, such as glioblastoma multiforme or anaplastic astrocytoma, showing recurrence or progression after standard therapy.

Exclusion Criteria

• N/A

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

P05557

Identifier Type: -

Identifier Source: org_study_id