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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

February 12, 2008
June 8, 2011
March 2008
December 2009   (final data collection date for primary outcome measure)
Hand grip strength and body weight [ Time Frame: Twelve weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00622193 on ClinicalTrials.gov Archive Site
Quality of Life and Biomarker [ Time Frame: Twelve weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Dose Range Study of Anamorelin in Patients With Non-small Cell Lung Cancer
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

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

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.
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Carcinoma, Non-Small-Cell Lung
  • Drug: anamorelin HCl
    50 mg tablet
    Other Name: ST-1291
  • Drug: anamorelin HCl
    100 mg tablet
    Other Name: ST-1291
  • Drug: placebo
    placebo tablet
    Other Name: Placebo
  • Experimental: 1 Active 50 mg
    Intervention: Drug: anamorelin HCl
  • Experimental: 2 Active 100 mg
    Intervention: Drug: anamorelin HCl
  • Placebo Comparator: 3 Placebo
    Intervention: Drug: placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
228
December 2009
December 2009   (final data collection date for primary outcome measure)

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
Both
18 Years to 85 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   India
 
NCT00622193
ST-ANAM-207
Yes
Suzan Allen, Helsinn Therapeutics (U.S.), Inc.
Helsinn Therapeutics (U.S.), Inc
Not Provided
Study Director: Jennifer Temel, MD Massachusetts General Hospital
Helsinn Therapeutics (U.S.), Inc
June 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP