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
18 Years
85 Years
Both
Carcinoma, Non-Small-Cell Lung
Trial Information
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
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.
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Outcome Measure:
Hand grip strength and body weight
Outcome Time Frame:
Twelve weeks
Safety Issue:
No
Principal Investigator
Jennifer Temel, MD
Investigator Role:
Study Director
Investigator Affiliation:
Massachusetts General Hospital
Authority:
United States: Food and Drug Administration
Study ID:
ST-ANAM-207
NCT ID:
NCT00622193
Start Date:
March 2008
Completion Date:
December 2009
Related Keywords:
- Carcinoma, Non-Small-Cell Lung
- NSCLC
- Carcinoma
- Carcinoma, Non-Small-Cell Lung
Name | Location |
|---|---|
| Washington University School of Medicine | Saint Louis, Missouri 63110 |
| Beth Israel Deaconess Medical Center | Boston, Massachusetts 02215 |
| South Georgia Medical Center | Valdosta, Georgia 31603 |
| University of Arkansas for Medical Sciences | Little Rock, Arkansas 72205 |
| Massachusetts General Hospital | Boston, Massachusetts 02114-2617 |
| Duke University Medical Center | Durham, North Carolina 27710 |
| Caritas St. Elizabeth's Medical Center | Brighton, Massachusetts 02135-2997 |
| Augusta Oncology Associates | Augusta, Georgia 30901 |
| The West Clinic | Memphis, Tennessee 38120 |
| Osler Medical | West Melbourne, Florida 32901 |
| Investigative Clinical Research of Indiana | Indianapolis, Indiana 46254 |
| South Carolina Cancer Specialists | Hilton Head Island, South Carolina 29925 |
| The Methodist Hospital Research Institute | Houston, Texas 77030 |
| The West Clinic | Corinth, Mississippi 38834 |
| John Hopkins University | Baltimore, Maryland 21231 |
| Dana Farber Cancer Center | Boston, Massachusetts 02115 |
| Baylor College of Medicine/VAMC | Houston, Texas 77030 |
| North West Medical Specialties, PLLC | Puyallup, Washington 98372 |
