SCH 52365 Phase II Clinical Study: A Study on the Efficacy and Safety of Monotherapy With SCH 52365 in Patients With First Relapsed Anaplastic Astrocytoma (Study P03745)

NCT ID: NCT00783393

Last Updated: 2017-05-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-05-27
• Study Completion Date: 2005-06-17

Brief Summary

The primary purpose of the study is to evaluate the efficacy (overall response) and safety of temozolomide in Step 1 at the dose and regimen approved in the US and the EU countries (28 day cycles of temozolomide at 150 to 200 mg/m2 once daily for 5 consecutive days with a 23 day rest period) in patients with anaplastic astrocytoma at first relapse.

Conditions

Astrocytoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Single arm

The study consists of two steps:

• Step 1, the therapeutic study phase, comprising six cycles of treatment with temozolomide, and
• Step 2, the long-term treatment phase, where subjects with at least disease stabilization at the end of Step 1 may continue temozolomide treatment until unacceptable toxicity or disease progression occur, up to a maximum of 2 years from the start of treatment in Cycle 1.

Group Type: EXPERIMENTAL

Temozolomide

Intervention Type: DRUG

Temozolomide orally once daily for 5 consecutive days followed by a 23 day rest period to complete a 28 day treatment cycle. In Cycle 1, temozolomide will be administered at 150 mg/m2/day; in Cycle 2 and subsequent cycles, it will be administered at 100, 150, or 200 mg/m2, depending on hematology test results and adverse events observed.

Interventions

Temozolomide

Temozolomide orally once daily for 5 consecutive days followed by a 23 day rest period to complete a 28 day treatment cycle. In Cycle 1, temozolomide will be administered at 150 mg/m2/day; in Cycle 2 and subsequent cycles, it will be administered at 100, 150, or 200 mg/m2, depending on hematology test results and adverse events observed.

Intervention Type: DRUG

Other Intervention Names

Temodal, Temodar, SCH 052365

Eligibility Criteria

Inclusion Criteria

• Subject must have histologically confirmed anaplastic astrocytoma on the tentorium at first relapse, and satisfy the following:

• unequivocal evidence of tumor recurrence or aggravation by MRI scan after treatment for initial onset; the lesions must be measurable;
• anaplastic astrocytoma diagnosed histologically by the last pathological diagnostic tests (including initial diagnosis) prior to initial administration of temozolomide;
• tissue samples available for Central Pathologic Reviewer;
• pathologic diagnosis report by the study-conducting medical institution must be available for the sponsor.
• MRI-related criteria:

• MRI scan performed within 14 days before initial temozolomide administration;
• assessable tumor site confirmed by MRI;
• dosage of steroidal agents not increased within 7 days before MRI prior to initial temozolomide administration, except for postoperative subjects for first relapse;
• MRI performed at the Principal Investigator's study location or designated radiology facility during the study.
• Age >=18 years, either sex, inpatients or outpatients.
• Use of medically approved contraception methods in fertile subjects.
• Karnofsky performance status >=70.
• Adequate clinically laboratory values obtained within 14 days before initial temozolomide administration.
• Criteria regarding treatment of initial onset:

• tumor biopsy, regardless of tumor resection at initial diagnosis;
• prior radiation therapy;
• prior chemotherapy with up to one nitrosourea-containing regimen.
• Tumor may or may not have been surgically resected at first relapse, but residual measurable disease is required.
• For subjects who had surgical resection of tumor at first relapse:

• MRI scan must have been performed within 72 hours after surgery.
• the dose of steroidal agents must be reduced before temozolomide administration.
• Life expectancy >=12 weeks.
• Written informed consent obtained.

Exclusion Criteria

• History of treatment with dacarbazine.
• Subjects who received chemotherapy within 6 weeks before initial temozolomide administration.
• Subjects who received interstitial radiotherapy or stereotactic radiosurgery.
• Subjects who completed radiotherapy within 12 weeks before initial temozolomide administration.
• Surgery at first relapse (including biopsy) within 1 week before initial temozolomide administration.
• Subjects not recovered from acute toxicity due to previous therapy.
• High-risk subjects with complication of diseases other than malignant tumor, or who require systemic administration of antibiotics for infection.
• Previous or concurrent malignancies at other sites.
• Pregnant or nursing women.
• Women of childbearing potential not using an effective method of contraception.
• Subjects previously treated with temozolomide.
• Participation in an ongoing clinical study, or in other clinical studies within 6 months before initial temozolomide administration.
• Subjects found inappropriate for the study by the investigator or subinvestigator.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Study Documents

Document Type: CSR Synopsis

View Document

Other Identifiers

JPC02-351-21

Identifier Type: -

Identifier Source: secondary_id

P03745

Identifier Type: -

Identifier Source: org_study_id