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Temozolomide All-Case-Registered Surveillance (Designated Drug Use Investigation)(Study P05062)

NCT00705198 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 1804

Last updated 2016-11-15

No results posted yet for this study

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 malignant glioma (as monotherapy) when used in the daily medical practices.

Post-marketing surveys are not considered applicable clinical trials and thus the results of this survey will not be posted at its conclusion. The results will be submitted to public health officials as required by applicable national and international laws.

Conditions

Interventions

DRUG

Temozolomide (for newly diagnosed malignant glioma)

Temozolomide treatment for newly diagnosed malignant glioma. The usual dose for adults in combination with radiotherapy is 75 mg/m2 orally once daily for 42 consecutive days. After a 4 week rest period, monotherapy at 150 mg/m2 orally once daily for 5 consecutive days per 28 day treatment cycle is administered. The dose may be increased to 200 mg/m2 for the next 28 day treatment cycle. Temozolomide is administered as 20 mg and 100 mg capsules.

DRUG

Temozolomide (for relapsed malignant glioma)

Temozolomide treatment for relapsed malignant glioma. The usual dose for adults is 150 mg/m2 orally once daily for 5 consecutive days per 28 day treatment cycle. The dose may be increased to 200 mg/m2 for the next 28 day treatment cycle. Temozolomide is administered as 20 mg and 100 mg capsules.

RADIATION

Radiotherapy (for patients with newly diagnosed malignant glioma)

Although the study protocol does not clearly define how long this intervention is applied, radiotherapy is generally administered 5 days/week for 6 weeks to patients with newly diagnosed malignant glioma.

Sponsors & Collaborators

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-09-30
Primary Completion
2016-07-31
Completion
2016-07-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00705198 on ClinicalTrials.gov