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)

Astrocytoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00783393
• Other study ID #: P03745
• Secondary ID: JPC02-351-21
• Status: Completed
• Phase: Phase 2
• First received: October 30, 2008
• Last updated: May 12, 2017
• Start date: May 27, 2003
• Est. completion date: June 17, 2005

Study information

• Verified date: May 2017
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: June 17, 2005
• Est. primary completion date: June 17, 2005
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Astrocytoma

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall response in Step 1		6 months
Primary	Incidence rate and severity of adverse events with administration of temozolomide in Step 1		7 months (during temozolomide administration for 6 months and follow-up for 1 month)
Secondary	Progression-free survival in Step 1		6 months
Secondary	Overall survival in Step 1		6 months
Secondary	Tumor response in Step 1		6 months
Secondary	Neurological improvement in Step 1		6 months
Secondary	Progression-free survival, overall survival, overall response, effect on neurological symptoms, and safety in Step 2		6 months
Secondary	Progression-free survival in Step 2		Up to 2 years
Secondary	Overall survival in Step 2		Up to 2 years
Secondary	Overall response in Step 2		Up to 2 years
Secondary	Effect on neurological symptoms in Step 2		Up to 2 years
Secondary	Safety in Step 2		Up to 2 years