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

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ClinicalTrials.gov Identifier: NCT00622193
Recruitment Status : Completed
First Posted : February 22, 2008
Last Update Posted : April 14, 2017
Information provided by (Responsible Party):

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

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

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 228 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : March 2008
Primary Completion Date : December 2009
Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :
  1. Hand grip strength and body weight [ Time Frame: Twelve weeks ]

Secondary Outcome Measures :
  1. Quality of Life and Biomarker [ Time Frame: Twelve weeks ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00622193

  Show 33 Study Locations
Sponsors and Collaborators
Helsinn Therapeutics (U.S.), Inc
Study Director: Jennifer Temel, MD Massachusetts General Hospital
More Information

Responsible Party: Helsinn Therapeutics (U.S.), Inc
ClinicalTrials.gov Identifier: NCT00622193     History of Changes
Other Study ID Numbers: ST-ANAM-207
First Posted: February 22, 2008    Key Record Dates
Last Update Posted: April 14, 2017
Last Verified: April 2017

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

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases