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

This study has been completed.
Sponsor:
Information provided by:
Helsinn Therapeutics (U.S.), Inc
ClinicalTrials.gov Identifier:
NCT00622193
First received: February 12, 2008
Last updated: June 8, 2011
Last verified: June 2011
History of Changes
  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

  Show 33 Study Locations
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 May 23, 2013