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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00622193
Recruitment Status : Completed
First Posted : February 22, 2008
Last Update Posted : April 14, 2017
Information provided by (Responsible Party):
Helsinn Therapeutics (U.S.), Inc

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.

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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
Actual Primary Completion Date : December 2009
Actual Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

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

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 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
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

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 identifier (NCT number): NCT00622193

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Sponsors and Collaborators
Helsinn Therapeutics (U.S.), Inc
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Study Director: Jennifer Temel, MD Massachusetts General Hospital
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Responsible Party: Helsinn Therapeutics (U.S.), Inc Identifier: NCT00622193    
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:
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Carcinoma, Non-Small-Cell Lung
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases