Ignite Creation Date:
2025-12-25 @ 1:14 AM
Ignite Modification Date:
2025-12-25 @ 11:24 PM
Study NCT ID:
NCT00783393
Status:
COMPLETED
Last Update Posted:
2017-05-15
First Post:
2008-10-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief 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 (Study P03745)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001254', 'term': 'Astrocytoma'}], 'ancestors': [{'id': 'D005910', 'term': 'Glioma'}, {'id': 'D018302', 'term': 'Neoplasms, Neuroepithelial'}, {'id': 'D017599', 'term': 'Neuroectodermal Tumors'}, {'id': 'D009373', 'term': 'Neoplasms, Germ Cell and Embryonal'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077204', 'term': 'Temozolomide'}], 'ancestors': [{'id': 'D003606', 'term': 'Dacarbazine'}, {'id': 'D014226', 'term': 'Triazenes'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 32}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-05-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-05', 'completionDateStruct': {'date': '2005-06-17', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-05-12', 'studyFirstSubmitDate': '2008-10-30', 'studyFirstSubmitQcDate': '2008-10-30', 'lastUpdatePostDateStruct': {'date': '2017-05-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2008-10-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2005-06-17', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall response in Step 1', 'timeFrame': '6 months'}, {'measure': 'Incidence rate and severity of adverse events with administration of temozolomide in Step 1', 'timeFrame': '7 months (during temozolomide administration for 6 months and follow-up for 1 month)'}], 'secondaryOutcomes': [{'measure': 'Progression-free survival in Step 1', 'timeFrame': '6 months'}, {'measure': 'Overall survival in Step 1', 'timeFrame': '6 months'}, {'measure': 'Tumor response in Step 1', 'timeFrame': '6 months'}, {'measure': 'Neurological improvement in Step 1', 'timeFrame': '6 months'}, {'measure': 'Progression-free survival, overall survival, overall response, effect on neurological symptoms, and safety in Step 2', 'timeFrame': '6 months'}, {'measure': 'Progression-free survival in Step 2', 'timeFrame': 'Up to 2 years'}, {'measure': 'Overall survival in Step 2', 'timeFrame': 'Up to 2 years'}, {'measure': 'Overall response in Step 2', 'timeFrame': 'Up to 2 years'}, {'measure': 'Effect on neurological symptoms in Step 2', 'timeFrame': 'Up to 2 years'}, {'measure': 'Safety in Step 2', 'timeFrame': 'Up to 2 years'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Astrocytoma']}, 'referencesModule': {'availIpds': [{'url': 'http://www.merck.com/clinical-trials/policies-perspectives.html', 'type': 'CSR Synopsis'}]}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Subject must have histologically confirmed anaplastic astrocytoma on the tentorium at first relapse, and satisfy the following:\n\n * unequivocal evidence of tumor recurrence or aggravation by MRI scan after treatment for initial onset; the lesions must be measurable;\n * anaplastic astrocytoma diagnosed histologically by the last pathological diagnostic tests (including initial diagnosis) prior to initial administration of temozolomide;\n * tissue samples available for Central Pathologic Reviewer;\n * pathologic diagnosis report by the study-conducting medical institution must be available for the sponsor.\n* MRI-related criteria:\n\n * MRI scan performed within 14 days before initial temozolomide administration;\n * assessable tumor site confirmed by MRI;\n * dosage of steroidal agents not increased within 7 days before MRI prior to initial temozolomide administration, except for postoperative subjects for first relapse;\n * MRI performed at the Principal Investigator's study location or designated radiology facility during the study.\n* Age \\>=18 years, either sex, inpatients or outpatients.\n* Use of medically approved contraception methods in fertile subjects.\n* Karnofsky performance status \\>=70.\n* Adequate clinically laboratory values obtained within 14 days before initial temozolomide administration.\n* Criteria regarding treatment of initial onset:\n\n * tumor biopsy, regardless of tumor resection at initial diagnosis;\n * prior radiation therapy;\n * prior chemotherapy with up to one nitrosourea-containing regimen.\n* Tumor may or may not have been surgically resected at first relapse, but residual measurable disease is required.\n* For subjects who had surgical resection of tumor at first relapse:\n\n * MRI scan must have been performed within 72 hours after surgery.\n * the dose of steroidal agents must be reduced before temozolomide administration.\n* Life expectancy \\>=12 weeks.\n* Written informed consent obtained.\n\nExclusion Criteria:\n\n* History of treatment with dacarbazine.\n* Subjects who received chemotherapy within 6 weeks before initial temozolomide administration.\n* Subjects who received interstitial radiotherapy or stereotactic radiosurgery.\n* Subjects who completed radiotherapy within 12 weeks before initial temozolomide administration.\n* Surgery at first relapse (including biopsy) within 1 week before initial temozolomide administration.\n* Subjects not recovered from acute toxicity due to previous therapy.\n* High-risk subjects with complication of diseases other than malignant tumor, or who require systemic administration of antibiotics for infection.\n* Previous or concurrent malignancies at other sites.\n* Pregnant or nursing women.\n* Women of childbearing potential not using an effective method of contraception.\n* Subjects previously treated with temozolomide.\n* Participation in an ongoing clinical study, or in other clinical studies within 6 months before initial temozolomide administration.\n* Subjects found inappropriate for the study by the investigator or subinvestigator."}, 'identificationModule': {'nctId': 'NCT00783393', 'briefTitle': '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)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merck Sharp & Dohme LLC'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'P03745'}, 'secondaryIdInfos': [{'id': 'JPC02-351-21'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Single arm', 'description': 'The study consists of two steps:\n\n* Step 1, the therapeutic study phase, comprising six cycles of treatment with temozolomide, and\n* 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.', 'interventionNames': ['Drug: Temozolomide']}], 'interventions': [{'name': 'Temozolomide', 'type': 'DRUG', 'otherNames': ['Temodal, Temodar, SCH 052365'], 'description': '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.', 'armGroupLabels': ['Single arm']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Merck Sharp & Dohme LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}