Dose Range Study of Anamorelin in Patients With Non-small Cell Lung Cancer - Full Text View

Purpose

The purpose of this study is to evaluate doses of anamorelin for safety and efficacy in patients with non-small cell lung cancer.

Condition	Intervention	Phase
Carcinoma, Non-Small-Cell Lung	Drug: anamorelin HCl Drug: placebo	Phase 2

Study Type:	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
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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer

U.S. FDA Resources

Further study details as provided by Helsinn Therapeutics (U.S.), Inc:

Primary Outcome Measures:

Hand grip strength and body weight [ Time Frame: Twelve weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Quality of Life and Biomarker [ Time Frame: Twelve weeks ] [ Designated as safety issue: No ]

Enrollment:	228
Study Start Date:	March 2008
Study Completion Date:	December 2009
Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 Active 50 mg	Drug: anamorelin HCl 50 mg tablet Other Name: ST-1291
Experimental: 2 Active 100 mg	Drug: anamorelin HCl 100 mg tablet Other Name: ST-1291
Placebo Comparator: 3 Placebo	Drug: placebo placebo tablet Other Name: Placebo

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

Ages Eligible for Study:	18 Years to 85 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00622193

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Locations

United States, Arkansas
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205
United States, Florida
Osler Medical
Melbourne, Florida, United States, 32901
United States, Georgia
Augusta Oncology Associates
Augusta, Georgia, United States, 30901
South Georgia Medical Center
Valdosta, Georgia, United States, 31602
United States, Indiana
Investigative Clinical Research of Indiana
Indianapolis, Indiana, United States, 46260
United States, Maryland
John Hopkins University
Baltimore, Maryland, United States, 21287
United States, Massachusetts
Caritas St. Elizabeth's Medical Center
Boston, Massachusetts, United States, 02135
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Dana Farber Cancer Center
Boston, Massachusetts, United States, 02115
United States, Mississippi
The West Clinic
Corinth, Mississippi, United States, 38834
The West Clinic
Southaven, Mississippi, United States, 38671
United States, Missouri
Washington University School of Medicine
St Louis, Missouri, United States, 63110
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
United States, South Carolina
South Carolina Cancer Specialists
Hilton Head Island, South Carolina, United States, 29926
United States, Tennessee
The West Clinic
Memphis, Tennessee, United States, 38120
United States, Texas
Baylor College of Medicine/VAMC
Houston, Texas, United States, 77030
The Methodist Hospital Research Institute
Houston, Texas, United States, 77030
United States, Washington
North West Medical Specialties, PLLC
Puyallup, Washington, United States, 98372
India
Regional Cancer Centre Indira Gandhi Institute of Medical Sciences
Patna, Bihar, India
Cancer Clinic 208
Nagpur, Maharashtra, India
Noble Hospital
Pune, Maharashtra, India
Ruby Hall Clinic
Pune, Maharashtra, India
Kaushalya Medical Foundation Trust Hospital
Thane, Maharashtra, India
SEAROC Cancer Center
Jaipur, Rajasthan, India
Jawaharlal Nehru Cancer Hospital and Research Centre
Bhopal, India
Kamakshi Memorial Hospital
Chennai, India
Dharamshila Cancer Hospital and Research Center
Delhi, India
Birla Cancer Centre SMS Medical College Hospital
Jaipur, India
Bhagwan Mahaveer Cancer Hospital and Resaerch Center
Jaipur, India
Kodlikeri Memorial Hospital
Maharashtra, India
Jaslok Hospital and Research Centre
Mumbai, India
Shatabdi Super Speciality Hospital
Mumbai Naka, Nasik, India

Sponsors and Collaborators

Helsinn Therapeutics (U.S.), Inc

Investigators

Study Director:

Jennifer Temel, MD

Massachusetts General Hospital

More Information

No publications provided

Responsible Party:	Suzan Allen, Helsinn Therapeutics (U.S.), Inc.
ClinicalTrials.gov Identifier:	NCT00622193 History of Changes
Other Study ID Numbers:	ST-ANAM-207
Study First Received:	February 12, 2008
Last Updated:	June 8, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by Helsinn Therapeutics (U.S.), Inc:

NSCLC

Additional relevant MeSH terms:

Carcinoma
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms

Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on June 17, 2013