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

This study has been completed.
Information provided by (Responsible Party):
Helsinn Therapeutics (U.S.), Inc Identifier:
First received: February 12, 2008
Last updated: April 12, 2017
Last verified: April 2017
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
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:

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

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

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

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

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.

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
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, see Learn About Clinical Studies.

Please refer to this study by its identifier: 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 Identifier: NCT00622193     History of Changes
Other Study ID Numbers: ST-ANAM-207
Study First Received: February 12, 2008
Last Updated: April 12, 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 processed this record on June 26, 2017