Ignite Creation Date:
2025-12-25 @ 2:51 AM
Ignite Modification Date:
2025-12-26 @ 1:32 AM
Study NCT ID:
NCT00255333
Status:
TERMINATED
Last Update Posted:
2007-05-14
First Post:
2005-11-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
INNO-105 in Patients With Solid Tumors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004744', 'term': 'Enkephalin, Methionine'}], 'ancestors': [{'id': 'D004745', 'term': 'Enkephalins'}, {'id': 'D018847', 'term': 'Opioid Peptides'}, {'id': 'D009479', 'term': 'Neuropeptides'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D009419', 'term': 'Nerve Tissue Proteins'}, {'id': 'D011506', 'term': 'Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'count': 24}}, 'statusModule': {'whyStopped': 'Development of this compound was discontinued.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2005-11'}, 'statusVerifiedDate': '2007-05', 'completionDateStruct': {'date': '2007-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2007-05-11', 'studyFirstSubmitDate': '2005-11-16', 'studyFirstSubmitQcDate': '2005-11-17', 'lastUpdatePostDateStruct': {'date': '2007-05-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-11-18', 'type': 'ESTIMATED'}}, 'conditionsModule': {'conditions': ['Tumors']}, 'descriptionModule': {'briefSummary': 'The safety, tolerability and pharmacokinetics of INNO-105, an investigational anticancer drug, are being studied in patients with solid tumors.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Have a histologically or cytologically confirmed diagnosis of a solid malignancy (patients may have either measurable or nonmeasurable disease).\n2. Be ≥18 years old.\n3. Not eligible for effective therapy likely to provide clinical benefit.\n4. Have an Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤2.\n5. Acceptable pretreatment clinical laboratory results.\n6. Life expectancy of greater than 12 weeks.\n\nExclusion Criteria:\n\n1. Have received previous treatment with INNO-105.\n2. Have an active, uncontrolled systemic infection considered opportunistic, life threatening, or clinically significant at the time of treatment.\n3. Are pregnant or lactating.\n4. Have a psychiatric disorder(s) that would interfere with consent, study participation, or follow-up.\n5. Have received any chemotherapy, immunotherapy, vaccines, monoclonal antibodies, major surgery, or irradiation, whether conventional or investigational, within 2 weeks of treatment in this study.\n6. Have not recovered from acute toxicity of all previous therapy prior to enrollment.\n7. Have symptomatic or untreated central nervous system (CNS) metastases.\n8. Have a susceptibility to hypotension, bradycardia, and/or hypopnea, such as patients with known coronary heart disease, arrhythmias, cerebral vascular disease, and chronic obstructive airways disease (CO2-retaining).'}, 'identificationModule': {'nctId': 'NCT00255333', 'briefTitle': 'INNO-105 in Patients With Solid Tumors', 'organization': {'class': 'INDUSTRY', 'fullName': 'Innovive Pharmaceuticals'}, 'officialTitle': 'A Phase I, Open-Label, Dose Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Weekly Intravenous INNO-105 in Adult Patients With Advanced Solid Malignancies', 'orgStudyIdInfo': {'id': 'INNO-105-901'}}, 'armsInterventionsModule': {'interventions': [{'name': 'INNO-105', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '21201', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'University of Maryland Greenebaum Cancer Center', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '75201', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Mary Crowley Medical Research Center', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}], 'overallOfficials': [{'name': 'Casey Cunningham, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mary Crowley Medical Research Center'}, {'name': 'Edward Sausville, M.D., Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Maryland Greenebaum Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Innovive Pharmaceuticals', 'class': 'INDUSTRY'}}}}