Clinical trial NCT00622193: Dose Range Study of Anamorelin in Patients With Non-small Cell Lung Cancer
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Carcinoma, Non-Small-Cell Lung
Keywords: NSCLC
Lead sponsor: Helsinn Therapeutics (U.S.), Inc
Sponsor class: INDUSTRY
First posted: 2008-02-22
Enrollment: 228
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* stage IIIB or IV NSCLC
* eligible for treatment of NSCLC with paclitaxel and carboplatin +/- bevacizumab

Exclusion Criteria:

* mixed large and small cell histologies for lung cancer
* significant obesity, BMI \> 30

Primary outcomes:
measure: Hand grip strength and body weight
timeFrame: Twelve weeks
Secondary outcomes:
measure: Quality of Life and Biomarker
timeFrame: Twelve weeks
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: University of Arkansas for Medical Sciences
state: Arkansas
city: Melbourne
country: United States
facility: Osler Medical
state: Florida
city: Augusta
country: United States
facility: Augusta Oncology Associates
state: Georgia
city: Valdosta
country: United States
facility: South Georgia Medical Center
state: Georgia
city: Indianapolis
country: United States
facility: Investigative Clinical Research of Indiana
state: Indiana
city: Baltimore
country: United States
facility: John Hopkins University
state: Maryland
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Dana Farber Cancer Center
state: Massachusetts
city: Boston
country: United States
facility: Caritas St. Elizabeth's Medical Center
state: Massachusetts
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Corinth
country: United States
facility: The West Clinic
state: Mississippi
city: Southaven
country: United States
facility: The West Clinic
state: Mississippi
city: St Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Hilton Head Island
country: United States
facility: South Carolina Cancer Specialists
state: South Carolina
city: Memphis
country: United States
facility: The West Clinic
state: Tennessee
city: Houston
country: United States
facility: Baylor College of Medicine/VAMC
state: Texas
city: Houston
country: United States
facility: The Methodist Hospital Research Institute
state: Texas
city: Puyallup
country: United States
facility: North West Medical Specialties, PLLC
state: Washington
city: Patna
country: India
facility: Regional Cancer Centre Indira Gandhi Institute of Medical Sciences
state: Bihar
city: Nagpur
country: India
facility: Cancer Clinic 208
state: Maharashtra
city: Pune
country: India
facility: Noble Hospital
state: Maharashtra
city: Pune
country: India
facility: Ruby Hall Clinic
state: Maharashtra
city: Thane
country: India
facility: Kaushalya Medical Foundation Trust Hospital
state: Maharashtra
city: Jaipur
country: India
facility: SEAROC Cancer Center
state: Rajasthan
city: Bhopal
country: India
facility: Jawaharlal Nehru Cancer Hospital and Research Centre
city: Chennai
country: India
facility: Kamakshi Memorial Hospital
city: Delhi
country: India
facility: Dharamshila Cancer Hospital and Research Center
city: Jaipur
country: India
facility: Bhagwan Mahaveer Cancer Hospital and Resaerch Center
city: Jaipur
country: India
facility: Birla Cancer Centre SMS Medical College Hospital
city: Maharashtra
country: India
facility: Kodlikeri Memorial Hospital
city: Mumbai Naka, Nasik
country: India
facility: Shatabdi Super Speciality Hospital
city: Mumbai
country: India
facility: Jaslok Hospital and Research Centre
Study officials:
affiliation: Massachusetts General Hospital
name: Jennifer Temel, MD
role: STUDY_DIRECTOR
References: