Dose Range Study of Anamorelin in Patients With Non-small Cell Lung Cancer
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Interventions
- Drug: placebo
- Registration Number
- NCT00622193
- Lead Sponsor
- Helsinn Therapeutics (U.S.), Inc
- Brief Summary
The purpose of this study is to evaluate doses of anamorelin for safety and efficacy in patients with non-small cell lung cancer.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 228
- stage IIIB or IV NSCLC
- eligible for treatment of NSCLC with paclitaxel and carboplatin +/- bevacizumab
- mixed large and small cell histologies for lung cancer
- significant obesity, BMI > 30
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 Active 50 mg anamorelin HCl - 2 Active 100 mg anamorelin HCl - 3 Placebo placebo -
- Primary Outcome Measures
Name Time Method Hand grip strength and body weight Twelve weeks
- Secondary Outcome Measures
Name Time Method Quality of Life and Biomarker Twelve weeks
Trial Locations
- Locations (31)
John Hopkins University
🇺🇸Baltimore, Maryland, United States
SEAROC Cancer Center
🇮🇳Jaipur, Rajasthan, India
University of Arkansas for Medical Sciences
🇺🇸Little Rock, Arkansas, United States
The Methodist Hospital Research Institute
🇺🇸Houston, Texas, United States
Kodlikeri Memorial Hospital
🇮🇳Maharashtra, India
Shatabdi Super Speciality Hospital
🇮🇳Mumbai Naka, Nasik, India
Augusta Oncology Associates
🇺🇸Augusta, Georgia, United States
Dharamshila Cancer Hospital and Research Center
🇮🇳Delhi, India
Cancer Clinic 208
🇮🇳Nagpur, Maharashtra, India
South Georgia Medical Center
🇺🇸Valdosta, Georgia, United States
Baylor College of Medicine/VAMC
🇺🇸Houston, Texas, United States
Caritas St. Elizabeth's Medical Center
🇺🇸Boston, Massachusetts, United States
Duke University Medical Center
🇺🇸Durham, North Carolina, United States
Regional Cancer Centre Indira Gandhi Institute of Medical Sciences
🇮🇳Patna, Bihar, India
Birla Cancer Centre SMS Medical College Hospital
🇮🇳Jaipur, India
The West Clinic
🇺🇸Memphis, Tennessee, United States
Osler Medical
🇺🇸Melbourne, Florida, United States
Investigative Clinical Research of Indiana
🇺🇸Indianapolis, Indiana, United States
North West Medical Specialties, PLLC
🇺🇸Puyallup, Washington, United States
Beth Israel Deaconess Medical Center
🇺🇸Boston, Massachusetts, United States
Noble Hospital
🇮🇳Pune, Maharashtra, India
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
Bhagwan Mahaveer Cancer Hospital and Resaerch Center
🇮🇳Jaipur, India
Jawaharlal Nehru Cancer Hospital and Research Centre
🇮🇳Bhopal, India
Kamakshi Memorial Hospital
🇮🇳Chennai, India
Jaslok Hospital and Research Centre
🇮🇳Mumbai, India
Kaushalya Medical Foundation Trust Hospital
🇮🇳Thane, Maharashtra, India
Dana Farber Cancer Center
🇺🇸Boston, Massachusetts, United States
Washington University School of Medicine
🇺🇸St Louis, Missouri, United States
South Carolina Cancer Specialists
🇺🇸Hilton Head Island, South Carolina, United States
Ruby Hall Clinic
🇮🇳Pune, Maharashtra, India