Temozolomide All-Case-Registered Surveillance (Designated Drug Use Investigation)(Study P05062)
NCT ID: NCT00705198
Last Updated: 2016-11-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
1804 participants
OBSERVATIONAL
2006-09-30
2016-07-31
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Newly diagnosed patients
Patients treated with temozolomide for newly diagnosed malignant glioma
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.
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.
Relapsed patients
Patients treated with temozolomide for relapsed malignant glioma
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.
Newly diagnosed anaplastic astrocytoma patients
Patients treated with temozolomide for newly diagnosed anaplastic astrocytoma
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.
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.
Interventions
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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.
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.
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Pregnant women and women who may be pregnant.
ALL
No
Sponsors
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Merck Sharp & Dohme LLC
INDUSTRY
Responsible Party
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Other Identifiers
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P05062
Identifier Type: -
Identifier Source: org_study_id