Ignite Creation Date:
2025-12-25 @ 1:07 AM
Ignite Modification Date:
2026-01-03 @ 2:50 AM
Study NCT ID:
NCT00622193
Status:
COMPLETED
Last Update Posted:
2017-04-14
First Post:
2008-02-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Dose Range Study of Anamorelin in Patients With Non-small Cell Lung Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002289', 'term': 'Carcinoma, Non-Small-Cell Lung'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 228}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-04', 'dispFirstSubmitDate': '2011-06-08', 'completionDateStruct': {'date': '2009-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-04-12', 'studyFirstSubmitDate': '2008-02-12', 'dispFirstSubmitQcDate': '2011-06-08', 'studyFirstSubmitQcDate': '2008-02-12', 'dispFirstPostDateStruct': {'date': '2011-06-23', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2017-04-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2008-02-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Hand grip strength and body weight', 'timeFrame': 'Twelve weeks'}], 'secondaryOutcomes': [{'measure': 'Quality of Life and Biomarker', 'timeFrame': 'Twelve weeks'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['NSCLC'], 'conditions': ['Carcinoma, Non-Small-Cell Lung']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate doses of anamorelin for safety and efficacy in patients with non-small cell lung cancer.', 'detailedDescription': 'Cancer cachexia is a devastating, often late-stage complication of an underlying malignancy. Despite the significant importance of cancer-related cachexia, treatments are lacking and there are no products approved for this indication. Anamorelin HCl, by virtue of its ghrelin agonist activity, may serve a role in the treatment of cancer cachexia. This placebo controlled dose range study will evaluate the safety and efficacy of anamorelin HCl in patients with non-small cell lung cancer, a cancer associated with a high prevalence of cachexia.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* stage IIIB or IV NSCLC\n* eligible for treatment of NSCLC with paclitaxel and carboplatin +/- bevacizumab\n\nExclusion Criteria:\n\n* mixed large and small cell histologies for lung cancer\n* significant obesity, BMI \\> 30'}, 'identificationModule': {'nctId': 'NCT00622193', 'briefTitle': 'Dose Range Study of Anamorelin in Patients With Non-small Cell Lung Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Helsinn Therapeutics (U.S.), Inc'}, 'officialTitle': 'A Randomized, Double-Blind, Placebo-Controlled, Multicenter Phase II Anamorelin HCl Dose Range Study to Evaluate the Safety and Efficacy of Anamorelin HCl in Patients With NSCLC', 'orgStudyIdInfo': {'id': 'ST-ANAM-207'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1 Active 50 mg', 'interventionNames': ['Drug: anamorelin HCl']}, {'type': 'EXPERIMENTAL', 'label': '2 Active 100 mg', 'interventionNames': ['Drug: anamorelin HCl']}, {'type': 'PLACEBO_COMPARATOR', 'label': '3 Placebo', 'interventionNames': ['Drug: placebo']}], 'interventions': [{'name': 'anamorelin HCl', 'type': 'DRUG', 'otherNames': ['ST-1291'], 'description': '50 mg tablet', 'armGroupLabels': ['1 Active 50 mg']}, {'name': 'anamorelin HCl', 'type': 'DRUG', 'otherNames': ['ST-1291'], 'description': '100 mg tablet', 'armGroupLabels': ['2 Active 100 mg']}, {'name': 'placebo', 'type': 'DRUG', 'description': 'placebo tablet', 'armGroupLabels': ['3 Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '72205', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': 'University of Arkansas for Medical Sciences', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'zip': '32901', 'city': 'Melbourne', 'state': 'Florida', 'country': 'United States', 'facility': 'Osler Medical', 'geoPoint': {'lat': 28.08363, 'lon': -80.60811}}, {'zip': '30901', 'city': 'Augusta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Augusta Oncology Associates', 'geoPoint': {'lat': 33.47097, 'lon': -81.97484}}, {'zip': '31602', 'city': 'Valdosta', 'state': 'Georgia', 'country': 'United States', 'facility': 'South Georgia Medical Center', 'geoPoint': {'lat': 30.83334, 'lon': -83.28032}}, {'zip': '46260', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Investigative Clinical Research of Indiana', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '21287', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'John Hopkins University', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Massachusetts General Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Dana Farber Cancer Center', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '02135', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': "Caritas St. Elizabeth's Medical Center", 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '02215', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Beth Israel Deaconess Medical Center', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '38834', 'city': 'Corinth', 'state': 'Mississippi', 'country': 'United States', 'facility': 'The West Clinic', 'geoPoint': {'lat': 34.93425, 'lon': -88.52227}}, {'zip': '38671', 'city': 'Southaven', 'state': 'Mississippi', 'country': 'United States', 'facility': 'The West Clinic', 'geoPoint': {'lat': 34.98898, 'lon': -90.01259}}, {'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Washington University School of Medicine', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '27710', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke University Medical Center', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'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': '38120', 'city': 'Memphis', 'state': 'Tennessee', 'country': 'United States', 'facility': 'The West Clinic', 'geoPoint': {'lat': 35.14953, 'lon': -90.04898}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Baylor College of Medicine/VAMC', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'The Methodist Hospital Research Institute', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '98372', 'city': 'Puyallup', 'state': 'Washington', 'country': 'United States', 'facility': 'North West Medical Specialties, PLLC', 'geoPoint': {'lat': 47.18538, 'lon': -122.2929}}, {'city': 'Patna', 'state': 'Bihar', 'country': 'India', 'facility': 'Regional Cancer Centre Indira Gandhi Institute of Medical Sciences', 'geoPoint': {'lat': 25.59408, 'lon': 85.13563}}, {'city': 'Nagpur', 'state': 'Maharashtra', 'country': 'India', 'facility': 'Cancer Clinic 208', 'geoPoint': {'lat': 21.14631, 'lon': 79.08491}}, {'city': 'Pune', 'state': 'Maharashtra', 'country': 'India', 'facility': 'Noble Hospital', 'geoPoint': {'lat': 18.51957, 'lon': 73.85535}}, {'city': 'Pune', 'state': 'Maharashtra', 'country': 'India', 'facility': 'Ruby Hall Clinic', 'geoPoint': {'lat': 18.51957, 'lon': 73.85535}}, {'city': 'Thane', 'state': 'Maharashtra', 'country': 'India', 'facility': 'Kaushalya Medical Foundation Trust Hospital', 'geoPoint': {'lat': 19.19704, 'lon': 72.96355}}, {'city': 'Jaipur', 'state': 'Rajasthan', 'country': 'India', 'facility': 'SEAROC Cancer Center', 'geoPoint': {'lat': 26.91962, 'lon': 75.78781}}, {'city': 'Bhopal', 'country': 'India', 'facility': 'Jawaharlal Nehru Cancer Hospital and Research Centre', 'geoPoint': {'lat': 23.25469, 'lon': 77.40289}}, {'city': 'Chennai', 'country': 'India', 'facility': 'Kamakshi Memorial Hospital', 'geoPoint': {'lat': 13.08784, 'lon': 80.27847}}, {'city': 'Delhi', 'country': 'India', 'facility': 'Dharamshila Cancer Hospital and Research Center', 'geoPoint': {'lat': 28.65195, 'lon': 77.23149}}, {'city': 'Jaipur', 'country': 'India', 'facility': 'Bhagwan Mahaveer Cancer Hospital and Resaerch Center', 'geoPoint': {'lat': 26.91962, 'lon': 75.78781}}, {'city': 'Jaipur', 'country': 'India', 'facility': 'Birla Cancer Centre SMS Medical College Hospital', 'geoPoint': {'lat': 26.91962, 'lon': 75.78781}}, {'city': 'Maharashtra', 'country': 'India', 'facility': 'Kodlikeri Memorial Hospital'}, {'city': 'Mumbai', 'country': 'India', 'facility': 'Jaslok Hospital and Research Centre', 'geoPoint': {'lat': 19.07283, 'lon': 72.88261}}, {'city': 'Mumbai Naka, Nasik', 'country': 'India', 'facility': 'Shatabdi Super Speciality Hospital', 'geoPoint': {'lat': 19.99727, 'lon': 73.79096}}], 'overallOfficials': [{'name': 'Jennifer Temel, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Massachusetts General Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Helsinn Therapeutics (U.S.), Inc', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}