Ignite Creation Date:
2025-12-24 @ 11:52 PM
Ignite Modification Date:
2026-01-11 @ 1:44 AM
Study NCT ID:
NCT00513851
Status:
COMPLETED
Last Update Posted:
2011-09-27
First Post:
2007-08-07
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Phase 1 Study of OSI-930 in Cancer Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002289', 'term': 'Carcinoma, Non-Small-Cell Lung'}, {'id': 'D055752', 'term': 'Small Cell Lung Carcinoma'}, {'id': 'D014594', 'term': 'Uterine Neoplasms'}, {'id': 'D010051', 'term': 'Ovarian Neoplasms'}, {'id': 'D007680', 'term': 'Kidney Neoplasms'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D002583', 'term': 'Uterine Cervical Neoplasms'}, {'id': 'D009362', 'term': 'Neoplasm Metastasis'}, {'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'id': 'D046152', 'term': 'Gastrointestinal Stromal Tumors'}], 'ancestors': [{'id': 'D002283', 'term': 'Carcinoma, Bronchogenic'}, {'id': 'D001984', 'term': 'Bronchial Neoplasms'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D005833', 'term': 'Genital Neoplasms, Female'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D014591', 'term': 'Uterine Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D010049', 'term': 'Ovarian Diseases'}, {'id': 'D000291', 'term': 'Adnexal Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D006058', 'term': 'Gonadal Disorders'}, {'id': 'D014571', 'term': 'Urologic Neoplasms'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D002577', 'term': 'Uterine Cervical Diseases'}, {'id': 'D009385', 'term': 'Neoplastic Processes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}, {'id': 'D009372', 'term': 'Neoplasms, Connective Tissue'}, {'id': 'D018204', 'term': 'Neoplasms, Connective and Soft Tissue'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C505207', 'term': 'OSI 930'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-09', 'completionDateStruct': {'date': '2009-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-09-26', 'studyFirstSubmitDate': '2007-08-07', 'studyFirstSubmitQcDate': '2007-08-08', 'lastUpdatePostDateStruct': {'date': '2011-09-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-08-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Determine the maximum tolerated dose (MTD) for both the once daily (QD) and twice daily (BID) dosing schedules and establish a recommended phase 2 dose of OSI-930', 'timeFrame': '2.5 years'}], 'secondaryOutcomes': [{'measure': 'Safety, Pharmacokinetic profile, Pharmacodynamic relationships, Preliminary antitumor activity', 'timeFrame': '2.5 years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Advanced Cancer', 'Non-small cell lung cancer', 'Small cell lung cancer', 'Uterine cancer', 'Ovarian cancer', 'Renal cancer', 'Head and neck cancer', 'Cervical cancer', 'Metastatic cancer', 'Colorectal cancer', 'Gastrointestinal stromal tumors'], 'conditions': ['Advanced Solid Tumors']}, 'descriptionModule': {'briefSummary': 'Open label, phase 1, dose escalation', 'detailedDescription': 'Multicenter, open-label, phase 1, dose escalation study to determine the maximum tolerated dose on both once daily (QD) and twice daily (BID) schedules.\n\nPatients may continue to receive OSI-930 until one of the following occurs: disease progression, adverse event requiring withdrawal, failure to recover from toxicity despite a 14-day dosing interruption, medical or ethical reasons, patient request, or patient death.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\nHistologically or cytologically documented malignancy that is now advanced and/or metastatic and refractory to established forms of therapy or for which no effective therapy exists.\n\nAge \\>/= 18 years, ECOG PS 0-2, life expectancy \\>/= 12 weeks Prior chemotherapy is permitted provided that a minimum of 3 weeks has elapsed. Prior tyrosine kinase inhibitor therapy is permitted. Patients must have recovered from any treatment-related toxicities (with some exceptions) prior to registration.\n\nPrior hormonal therapy is permitted provided it is discontinued prior to registration (with the exception of prostate cancer patients who have been on hormone therapy for at least 3 months).\n\nPrior radiation therapy is permitted provided that it did not exceed 25% of bone marrow reserve and patients have recovered from the toxic effects. A minimum of 21 days must have elapsed unless the radiotherapy was palliative and nonmyelosuppressive.\n\nANC \\>/= 1.5 x 10\\^9/L, PLT \\>/= 100 x 10\\^9/L; bilirubin \\</= 1.5 x upper limit of normal (ULN), AST and ALT \\</= 2.5 x ULN; creatinine \\</= 1.5 ULN Accessible for repeat dosing and follow-up. Patients must practice effective contraceptive measures throughout the study. Provide written informed consent.\n\nExclusion Criteria:\n\nSymptomatic brain metastases which are not stable, require steroids, are potentially life-threatening or that have required radiation within the last 28 days.\n\nHistory of allergic reaction attributed to a similar compound as study drug. Significant cardiac disease unless well controlled, poorly controlled hypertension.\n\nActive or uncontrolled infections of serious illnesses or medical conditions that could interfere with participation.\n\nHistory of any psychiatric condition that might impair the patient's ability to provide informed consent or participate.\n\nConcurrent anticancer therapy. Use of CYP3A4 inducers/inhibitors during the 14 days prior to first dose. Pregnant or breast-feeding females."}, 'identificationModule': {'nctId': 'NCT00513851', 'briefTitle': 'Phase 1 Study of OSI-930 in Cancer Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Astellas Pharma Inc'}, 'officialTitle': 'A Phase I Dose Escalation Study of Daily Oral OSI-930 in Patients With Advanced Solid Tumors', 'orgStudyIdInfo': {'id': 'OSI-930-102'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Once Daily Dosing', 'interventionNames': ['Drug: OSI-930']}, {'type': 'EXPERIMENTAL', 'label': '2', 'description': 'Twice Daily Dosing', 'interventionNames': ['Drug: OSI-930']}], 'interventions': [{'name': 'OSI-930', 'type': 'DRUG', 'description': 'Oral OSI-930 administered once daily at increasing doses until disease progression or unacceptable toxicity', 'armGroupLabels': ['1']}, {'name': 'OSI-930', 'type': 'DRUG', 'description': 'Oral OSI-930 administered twice daily at increasing doses until disease progression or unacceptable toxicity', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': 'University of Colorado Cancer Center', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Dana-Farber Cancer Institute', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': 'SM2 5PT', 'city': 'Sutton', 'state': 'Surrey', 'country': 'United Kingdom', 'facility': 'Cancer Research UK Professor of Medical Oncology', 'geoPoint': {'lat': 51.35, 'lon': -0.2}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Astellas Pharma Inc', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'OSI Pharmaceuticals', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}