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


Phase 2
18 Years
85 Years
Not Enrolling
Both
Carcinoma, Non-Small-Cell Lung

Thank you

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