Ignite Creation Date:
2025-12-24 @ 4:34 PM
Ignite Modification Date:
2025-12-26 @ 3:01 AM
Study NCT ID:
NCT00881166
Status:
COMPLETED
Last Update Posted:
2024-08-02
First Post:
2009-04-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety of MP470 in Combination With Standard-of-Care Chemotherapy Regimens to Treat Solid Tumors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C521047', 'term': 'amuvatinib'}, {'id': 'D019772', 'term': 'Topotecan'}, {'id': 'D000077143', 'term': 'Docetaxel'}, {'id': 'D000069347', 'term': 'Erlotinib Hydrochloride'}, {'id': 'D017239', 'term': 'Paclitaxel'}, {'id': 'D016190', 'term': 'Carboplatin'}, {'id': 'D005047', 'term': 'Etoposide'}], 'ancestors': [{'id': 'D002166', 'term': 'Camptothecin'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D043823', 'term': 'Taxoids'}, {'id': 'D043822', 'term': 'Cyclodecanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D004224', 'term': 'Diterpenes'}, {'id': 'D013729', 'term': 'Terpenes'}, {'id': 'D011799', 'term': 'Quinazolines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D056831', 'term': 'Coordination Complexes'}, {'id': 'D011034', 'term': 'Podophyllotoxin'}, {'id': 'D013764', 'term': 'Tetrahydronaphthalenes'}, {'id': 'D009281', 'term': 'Naphthalenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D005960', 'term': 'Glucosides'}, {'id': 'D006027', 'term': 'Glycosides'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 101}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2009-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-08-01', 'studyFirstSubmitDate': '2009-04-13', 'studyFirstSubmitQcDate': '2009-04-14', 'lastUpdatePostDateStruct': {'date': '2024-08-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2009-04-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maximum tolerated dose (MTD)', 'timeFrame': 'March 2010'}], 'secondaryOutcomes': [{'measure': 'Response rate', 'timeFrame': 'March 2010'}, {'measure': 'Pharmacokinetics, pharmacodynamic effects on biomarker modulation.', 'timeFrame': 'March 2010'}, {'measure': 'Experience DLT', 'timeFrame': 'March 2010'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['MP-470', 'Multi-targeted Tyrosine Kinase Inhibitor', 'Malignant disease'], 'conditions': ['Malignant Disease']}, 'referencesModule': {'references': [{'pmid': '24849582', 'type': 'DERIVED', 'citation': 'Mita M, Gordon M, Rosen L, Kapoor N, Choy G, Redkar S, Taverna P, Oganesian A, Sahai A, Azab M, Bristow R, Tolcher AW. Phase 1B study of amuvatinib in combination with five standard cancer therapies in adults with advanced solid tumors. Cancer Chemother Pharmacol. 2014 Jul;74(1):195-204. doi: 10.1007/s00280-014-2481-1. Epub 2014 May 22.'}]}, 'descriptionModule': {'briefSummary': 'Adult subjects with malignant disease appropriate for treatment with carboplatin/paclitaxel, carboplatin/etoposide, topotecan, docetaxel or erlotinib according to the standard dosing regimen will be enrolled in each treatment arm.\n\nPrimary objective: Determine the MTD.\n\nSecondary objectives: Response rates, PK, quantify MP-470 on PK of SOC, and collect pharmacodynamic information. Evaluate the overall safety of MP-470 when co-administered with specific SOC treatments.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Malignant disease appropriate for initiating treatment with carboplatin/paclitaxel, carboplatin/etoposide, topotecan, docetaxel, or erlotinib.\n2. Must be able to read, understand, and sign the IRB approved Informed Consent Form.\n3. At least 18 years old.\n4. Eastern Cooperative Oncology Group (ECOG) performance status 0-2.\n5. Adequate bone marrow function; normal renal and hepatic function, normal cardiac function.\n\nExclusion Criteria:\n\n1. Any other active invasive malignancy except non-melanoma skin cancers or cervical carcinoma in situ.\n2. History of significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure and/or myocardial infarction.\n3. Received any anticancer agent(s) within the past 3 weeks, including investigational agents, chemotherapy (6 weeks for nitrosoureas or mitomycin), immunotherapy, biologic or hormonal therapy other than LHRH agonists.\n4. Received prior radiation therapy within the past 4 weeks.\n5. Any serious, uncontrolled active infection that requires systemic treatment or known infection with HIV, HCV or HBV.\n6. Patient requires treatment with immunosuppressive agents other than corticosteroids appropriate for the SOC chemotherapy regimen or those at stable doses for at least 2 weeks.'}, 'identificationModule': {'nctId': 'NCT00881166', 'acronym': 'SGI-0470-02', 'briefTitle': 'Safety of MP470 in Combination With Standard-of-Care Chemotherapy Regimens to Treat Solid Tumors', 'organization': {'class': 'INDUSTRY', 'fullName': 'Astex Pharmaceuticals, Inc.'}, 'officialTitle': 'Safety and Dose Finding Study of Oral MP470, a Multi-targeted Tyrosine Kinase Inhibitor, in Combination With Standard-of-Care Chemotherapy Regimens', 'orgStudyIdInfo': {'id': 'SGI-0470-02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'oral MP-470 + paclitaxel/carboplatin', 'interventionNames': ['Drug: MP-470 + paclitaxel/carboplatin']}, {'type': 'EXPERIMENTAL', 'label': '2', 'description': 'oral MP-470 + carboplatin/etoposide', 'interventionNames': ['Drug: MP-470 + carboplatin/etoposide']}, {'type': 'EXPERIMENTAL', 'label': '3', 'description': 'oral MP-470 + topotecan', 'interventionNames': ['Drug: MP-470 + topotecan']}, {'type': 'EXPERIMENTAL', 'label': '4', 'description': 'oral MP-470 + docetaxel', 'interventionNames': ['Drug: MP-470 + docetaxel']}, {'type': 'EXPERIMENTAL', 'label': '5', 'description': 'oral MP-470 + Erlotinib', 'interventionNames': ['Drug: MP-470 + erlotinib']}], 'interventions': [{'name': 'MP-470 + topotecan', 'type': 'DRUG', 'description': 'Topotecan 1.5 mg/m2 IV infusion over 30 minutes on Days 1-5', 'armGroupLabels': ['3']}, {'name': 'MP-470 + docetaxel', 'type': 'DRUG', 'description': 'Docetaxel 75 mg/m2 IV infusion over 1 hour on Day 1', 'armGroupLabels': ['4']}, {'name': 'MP-470 + erlotinib', 'type': 'DRUG', 'description': '150 mg PO once daily at least 1 hour before or 2 hours after eating', 'armGroupLabels': ['5']}, {'name': 'MP-470 + paclitaxel/carboplatin', 'type': 'DRUG', 'description': 'Paclitaxel 200 mg/m2 IV infusion over 3 hours followed by carboplatin IV infusion over 1 hour to a target AUC of 6 mg∙min/mL on Day 1', 'armGroupLabels': ['1']}, {'name': 'MP-470 + carboplatin/etoposide', 'type': 'DRUG', 'description': 'Carboplatin IV infusion over 1 hour to target AUC of 5 mg min/mL on Day 1 followed by etoposide 100 mg/m2 IV infusion over 2 hours on Days 1-3', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85258', 'city': 'Scottsdale', 'state': 'Arizona', 'country': 'United States', 'facility': 'Premiere Oncology', 'geoPoint': {'lat': 33.50921, 'lon': -111.89903}}, {'zip': '90404', 'city': 'Santa Monica', 'state': 'California', 'country': 'United States', 'facility': 'Premiere Oncology', 'geoPoint': {'lat': 34.01949, 'lon': -118.49138}}, {'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Audie Murphy Veterans Memorial Hospital (VA)', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'CTRC at the UT Health Science Center at San Antonio', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'South Texas Accelerated Research Therapy (START)', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Astex Pharmaceuticals, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}