- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00783393
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)
May 12, 2017 updated by: Merck Sharp & Dohme LLC
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
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.
Study Overview
Study Type
Interventional
Enrollment (Actual)
32
Phase
- Phase 2
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Single arm
The study consists of two steps:
|
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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Overall response in Step 1
Time Frame: 6 months
|
6 months
|
Incidence rate and severity of adverse events with administration of temozolomide in Step 1
Time Frame: 7 months (during temozolomide administration for 6 months and follow-up for 1 month)
|
7 months (during temozolomide administration for 6 months and follow-up for 1 month)
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Progression-free survival in Step 1
Time Frame: 6 months
|
6 months
|
Overall survival in Step 1
Time Frame: 6 months
|
6 months
|
Tumor response in Step 1
Time Frame: 6 months
|
6 months
|
Neurological improvement in Step 1
Time Frame: 6 months
|
6 months
|
Progression-free survival, overall survival, overall response, effect on neurological symptoms, and safety in Step 2
Time Frame: 6 months
|
6 months
|
Progression-free survival in Step 2
Time Frame: Up to 2 years
|
Up to 2 years
|
Overall survival in Step 2
Time Frame: Up to 2 years
|
Up to 2 years
|
Overall response in Step 2
Time Frame: Up to 2 years
|
Up to 2 years
|
Effect on neurological symptoms in Step 2
Time Frame: Up to 2 years
|
Up to 2 years
|
Safety in Step 2
Time Frame: Up to 2 years
|
Up to 2 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 27, 2003
Primary Completion (Actual)
June 17, 2005
Study Completion (Actual)
June 17, 2005
Study Registration Dates
First Submitted
October 30, 2008
First Submitted That Met QC Criteria
October 30, 2008
First Posted (Estimate)
October 31, 2008
Study Record Updates
Last Update Posted (Actual)
May 15, 2017
Last Update Submitted That Met QC Criteria
May 12, 2017
Last Verified
May 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms, Glandular and Epithelial
- Glioma
- Neoplasms, Neuroepithelial
- Neuroectodermal Tumors
- Neoplasms, Germ Cell and Embryonal
- Neoplasms, Nerve Tissue
- Astrocytoma
- Molecular Mechanisms of Pharmacological Action
- Antineoplastic Agents
- Antineoplastic Agents, Alkylating
- Alkylating Agents
- Temozolomide
Other Study ID Numbers
- P03745
- JPC02-351-21
Plan for Individual participant data (IPD)
Study Data/Documents
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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