Ignite Creation Date:
2025-12-24 @ 7:11 PM
Ignite Modification Date:
2025-12-26 @ 8:33 AM
Study NCT ID:
NCT00277303
Status:
TERMINATED
Last Update Posted:
2010-02-22
First Post:
2006-01-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of XL999 in Patients With Metastatic Colorectal Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'id': 'D003110', 'term': 'Colonic Neoplasms'}], 'ancestors': [{'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': '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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 17}}, 'statusModule': {'whyStopped': 'Study was terminated due to cardiac toxicities in the subjects', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2005-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-02', 'completionDateStruct': {'date': '2007-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-02-18', 'studyFirstSubmitDate': '2006-01-12', 'studyFirstSubmitQcDate': '2006-01-12', 'lastUpdatePostDateStruct': {'date': '2010-02-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-01-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Response rate', 'timeFrame': 'Inclusion until disease progression'}, {'measure': 'Safety and tolerability', 'timeFrame': 'Inclusion until 30 days post last treatment'}], 'secondaryOutcomes': [{'measure': 'Progression-free survival', 'timeFrame': 'Inclusion until disease progression'}, {'measure': 'Duration of response', 'timeFrame': 'Inclusion until disease progression'}, {'measure': 'Overall survival', 'timeFrame': 'Inclusion until last Follow-up post last treatment or death'}, {'measure': 'Pharmacokinetic (PK) and Pharmacodynamic (PD) parameters', 'timeFrame': 'Samples will be collected pre-dose and immediately at the end for subjects in the second stage of the study'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Colon Cancer'], 'conditions': ['Colorectal Cancer']}, 'descriptionModule': {'briefSummary': 'This clinical study is being conducted at multiple sites to determine the activity, safety, and tolerability of XL999 when given weekly to patients with metastatic colorectal cancer (CRC). XL999 is a small molecule inhibitor of multiple kinases including VEGFR, PDGFR, FGFR, FLT-3, and Src, which are involved in tumor cell growth, formation of new blood vessels (angiogenesis), and metastasis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Males and females with histologically confirmed metastatic colorectal cancer\n* Measurable disease according to Response Criteria for Solid Tumors (RECIST)\n* At least 1 prior therapeutic regimen (chemotherapy or biologic)\n* ECOG performance status of 0 or 1\n* Life expectancy ≥3 months\n* Adequate organ and marrow function\n* No other malignancies within 5 years\n* Signed informed consent\n\nExclusion Criteria:\n\n* Radiation to ≥25% of bone marrow within 30 days of XL999 treatment\n* Treatment with systemic anticancer therapy within 30 days of XL999 treatment\n* Subject has not recovered to ≤ grade 1 or to within 10% of baseline from adverse events due to other medications administered \\>30 days prior to study enrollment\n* History of or known brain metastases, current spinal cord compression, or carcinomatous meningitis\n* Uncontrolled and/or intercurrent illness\n* Pregnant or breastfeeding females\n* Known HIV'}, 'identificationModule': {'nctId': 'NCT00277303', 'briefTitle': 'Study of XL999 in Patients With Metastatic Colorectal Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Symphony Evolution, Inc.'}, 'officialTitle': 'A Phase 2 Study of XL999 Administered Intravenously to Subjects With Metastatic Colorectal Cancer', 'orgStudyIdInfo': {'id': 'XL999-206'}}, 'armsInterventionsModule': {'interventions': [{'name': 'XL999', 'type': 'DRUG', 'description': "XL999 will be administered at 2.4 mg/kg as a 4-hour intravenous (IV) infusion. Subjects will receive XL999 infusions weekly for 8 weeks of treatment unless drug-related toxicity requires dosing delay. In the absence of progressive disease and unacceptable toxicity, subjects may receive XL999 treatment weekly for up to a year on this study. After 8 weeks, at the discretion of the investigator, one dose of four may be omitted for a subject's convenience."}]}, 'contactsLocationsModule': {'locations': [{'zip': '94904', 'city': 'Greenbrae', 'state': 'California', 'country': 'United States', 'facility': 'California Cancer Care, Inc.', 'geoPoint': {'lat': 37.94854, 'lon': -122.5247}}, {'zip': '32256', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'Integrated Community Oncology Network; Division of Clinical Research', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '34952', 'city': 'Port Saint Lucie', 'state': 'Florida', 'country': 'United States', 'facility': 'Hematology Oncology Associated of the Treasure Coast', 'geoPoint': {'lat': 27.29393, 'lon': -80.35033}}, {'zip': '60637', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'University of Chicago', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '60435', 'city': 'Joliet', 'state': 'Illinois', 'country': 'United States', 'facility': 'Joliet Oncology-Hematology Associated, Ltd.', 'geoPoint': {'lat': 41.52519, 'lon': -88.0834}}, {'zip': '46202', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Indiana University Cancer Center', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '10956', 'city': 'New City', 'state': 'New York', 'country': 'United States', 'facility': 'Hematology Oncology Associates of Rockland, PC', 'geoPoint': {'lat': 41.1476, 'lon': -73.98931}}, {'zip': '75230', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Center for Oncology Research and Treatment, PA', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}], 'overallOfficials': [{'name': 'Lynne Bui, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Exelixis'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Symphony Evolution, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Charles W. Finn, PhD, President and CEO', 'oldOrganization': 'Symphony Evolution, Inc.'}}}}