Ignite Creation Date:
2025-12-24 @ 11:58 PM
Ignite Modification Date:
2025-12-25 @ 9:55 PM
Study NCT ID:
NCT00267358
Status:
COMPLETED
Last Update Posted:
2013-09-02
First Post:
2005-12-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Placebo Controlled, Randomized Safety and Efficacy Study of RC-1291 in Cancer Anorexia/Cachexia.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'interventionModel': 'PARALLEL'}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-11'}, 'statusVerifiedDate': '2013-08', 'completionDateStruct': {'date': '2006-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-08-30', 'studyFirstSubmitDate': '2005-12-19', 'studyFirstSubmitQcDate': '2005-12-19', 'lastUpdatePostDateStruct': {'date': '2013-09-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-12-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Body weight'}, {'measure': 'Lean body mass'}, {'measure': 'Functional performance'}]}, 'conditionsModule': {'conditions': ['Cancer Cachexia']}, 'referencesModule': {'references': [{'pmid': '25524795', 'type': 'DERIVED', 'citation': 'Garcia JM, Boccia RV, Graham CD, Yan Y, Duus EM, Allen S, Friend J. Anamorelin for patients with cancer cachexia: an integrated analysis of two phase 2, randomised, placebo-controlled, double-blind trials. Lancet Oncol. 2015 Jan;16(1):108-16. doi: 10.1016/S1470-2045(14)71154-4. Epub 2014 Dec 16.'}]}, 'descriptionModule': {'briefSummary': 'Anorexia and cachexia are devastating complications in late-stage cancer patients and is strongly associated with mortality in these patients. Activation of Ghrelin receptors have been demonstrated to stimulate appetite. RC-1291 HCl, by virtue of its ghrelin like activity and Growth Hormone releasing effects may have a dual role in the reversal of cancer induced anorexia and cachexia. This placebo controlled study will evaluate the safety and efficacy of RC-1291 HCl in cancer patients with anorexia and cachexia.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Community-dwelling patients ≥ 18 years of age with incurable,histologically diagnosed cancer.\n* Involuntary loss of body weight of ≥ 5 % within the past 6 months\n\nExclusion Criteria:\n\n* Presently hospitalized or in a nursing care facility.\n* Inability to increase food intake from secondary causes.\n* Liver disease\n* If female-pregnant, breast-feeding or of childbearing potential.'}, 'identificationModule': {'nctId': 'NCT00267358', 'briefTitle': 'Placebo Controlled, Randomized Safety and Efficacy Study of RC-1291 in Cancer Anorexia/Cachexia.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Helsinn Therapeutics (U.S.), Inc'}, 'orgStudyIdInfo': {'id': 'RC-1291-205'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'RC-1291 HCl', 'description': '50 mg', 'interventionNames': ['Drug: RC-1291 HCl']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'RC-1291 HCl', 'type': 'DRUG', 'armGroupLabels': ['RC-1291 HCl']}, {'name': 'Placebo', 'type': 'DRUG', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85304', 'city': 'Glendale', 'state': 'Arizona', 'country': 'United States', 'facility': 'Palo Verde Hematology Oncology Ltd.', 'geoPoint': {'lat': 33.53865, 'lon': -112.18599}}, {'zip': '93309', 'city': 'Bakersfield', 'state': 'California', 'country': 'United States', 'facility': 'Comprehensive Blood & Cancer Center', 'geoPoint': {'lat': 35.37329, 'lon': -119.01871}}, {'zip': '92024', 'city': 'Encinitas', 'state': 'California', 'country': 'United States', 'facility': 'Pacific Oncology & Hematology Associates', 'geoPoint': {'lat': 33.03699, 'lon': -117.29198}}, {'zip': '92024', 'city': 'Encinitas', 'state': 'California', 'country': 'United States', 'facility': 'Pacific Oncology and Hematology Associates', 'geoPoint': {'lat': 33.03699, 'lon': -117.29198}}, {'zip': '93710', 'city': 'Fresno', 'state': 'California', 'country': 'United States', 'facility': 'Advanced Medical Research Institute', 'geoPoint': {'lat': 36.74773, 'lon': -119.77237}}, {'zip': '90057', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Kenmar Clinical Research', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '90057', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Kenmar Research Institute', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '90403', 'city': 'Santa Monica', 'state': 'California', 'country': 'United States', 'facility': 'Sant Chawla, Inc.', 'geoPoint': {'lat': 34.01949, 'lon': -118.49138}}, {'zip': '33511', 'city': 'Brandon', 'state': 'Florida', 'country': 'United States', 'facility': 'PAB Clinical Research', 'geoPoint': {'lat': 27.9378, 'lon': -82.28592}}, {'zip': '32901', 'city': 'Melbourne', 'state': 'Florida', 'country': 'United States', 'facility': 'Melbourne Internal Medicine Associates', 'geoPoint': {'lat': 28.08363, 'lon': -80.60811}}, {'zip': '32901', 'city': 'Melbourne', 'state': 'Florida', 'country': 'United States', 'facility': 'Osler Medical, Inc./ Osler Clinical Research', 'geoPoint': {'lat': 28.08363, 'lon': -80.60811}}, {'zip': '33607', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'Bay Area Oncology', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '20817', 'city': 'Bethesda', 'state': 'Maryland', 'country': 'United States', 'facility': 'Center for Cancer and Blood Disorders', 'geoPoint': {'lat': 38.98067, 'lon': -77.10026}}, {'zip': '43235', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'Hematology Oncology Consultants, Inc.', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '29406', 'city': 'Charleston', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Charleston Cancer Center', 'geoPoint': {'lat': 32.77632, 'lon': -79.93275}}, {'zip': '29210', 'city': 'Columbia', 'state': 'South Carolina', 'country': 'United States', 'facility': 'South Carolina Oncology Associates', 'geoPoint': {'lat': 34.00071, 'lon': -81.03481}}, {'zip': '29926', 'city': 'Hilton Head Island', 'state': 'South Carolina', 'country': 'United States', 'facility': 'South Carolina Cancer Specialists', 'geoPoint': {'lat': 32.19382, 'lon': -80.73816}}, {'zip': '77555', 'city': 'Galveston', 'state': 'Texas', 'country': 'United States', 'facility': 'University of Texas Medical Texas', 'geoPoint': {'lat': 29.30135, 'lon': -94.7977}}, {'zip': '98405', 'city': 'Tacoma', 'state': 'Washington', 'country': 'United States', 'facility': 'Multicare Health System', 'geoPoint': {'lat': 47.25288, 'lon': -122.44429}}], 'overallOfficials': [{'name': 'William Polvino, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Helsinn Therapeutics (U.S.), Inc'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Helsinn Therapeutics (U.S.), Inc', 'class': 'INDUSTRY'}}}}