Ignite Creation Date:
2025-12-24 @ 7:42 PM
Ignite Modification Date:
2025-12-26 @ 12:06 PM
Study NCT ID:
NCT01304303
Status:
COMPLETED
Last Update Posted:
2019-05-03
First Post:
2011-02-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pharmacokinetic and Safety Study of SPARC1023 Alone and in Carboplatin Combination
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 57}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-05', 'completionDateStruct': {'date': '2016-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-05-02', 'studyFirstSubmitDate': '2011-02-23', 'studyFirstSubmitQcDate': '2011-02-23', 'lastUpdatePostDateStruct': {'date': '2019-05-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-02-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Determination of MTD', 'timeFrame': 'One 21-day treatment cycle', 'description': 'MTD for SPARC1023 in combination with carboplatin will be determined. MTD will be defined as the SPARC1023 dose below the dose at which DLT (Dose Limiting Toxicity) is seen for ≥ 2 subjects.'}], 'secondaryOutcomes': [{'measure': 'Establishing the pharmacokinetic profile', 'timeFrame': 'One 21-day treatment cycle', 'description': 'Plasma levels of SPARC1023 and Carboplatin will be determined and PK parameters viz. Cmax, AUC0-t, AUC 0-∞, MRT, Tmax, t½ , Kel, Vd for SPARC1023 in combination with carboplatin will be evaluated.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['solid', 'tumor', 'taxane', 'platinum'], 'conditions': ['Solid Tumor in Advanced Stage']}, 'descriptionModule': {'briefSummary': 'Phase I study of SPARC1023 alone and in combination with carboplatin', 'detailedDescription': 'Pharmacokinetic profile and dose escalation study of SPARC1023 when administered as 30-min infusion.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥18 years\n* ECOG Performance Status ≤ 1.\n* Estimated life expectancy of at least 12-weeks;\n* Measurable disease as per RECIST guideline (Version 1.1);\n\nExclusion Criteria:\n\n* Any malignancy within past 5-years, except non-melanoma skin cancer, cervical intraepithelial neoplasia, or in situ cervical cancer\n* Known hypersensitivity to the study drugs\n* Treatment with any anti-cancer agents within 28 days of study entry\n* Presence of clinically evident active CNS metastases, including leptomeningeal involvement, requiring steroid or radiation therapy'}, 'identificationModule': {'nctId': 'NCT01304303', 'briefTitle': 'Pharmacokinetic and Safety Study of SPARC1023 Alone and in Carboplatin Combination', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sun Pharma Advanced Research Company Limited'}, 'orgStudyIdInfo': {'id': 'CLR_10_23'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'SPARC1023 I', 'interventionNames': ['Drug: SPARC1023 I']}, {'type': 'EXPERIMENTAL', 'label': 'SPARC1023 II', 'interventionNames': ['Drug: SPARC1023 II']}], 'interventions': [{'name': 'SPARC1023 I', 'type': 'DRUG', 'description': 'IV administration', 'armGroupLabels': ['SPARC1023 I']}, {'name': 'SPARC1023 II', 'type': 'DRUG', 'description': 'IV administration', 'armGroupLabels': ['SPARC1023 II']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Buffalo', 'state': 'New York', 'country': 'United States', 'facility': 'SPARC Site 1', 'geoPoint': {'lat': 42.88645, 'lon': -78.87837}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sun Pharma Advanced Research Company Limited', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}