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

Phase 2

Completed

• Conditions: Carcinoma, Non-Small-Cell Lung
• Interventions: Drug: anamorelin HCl; Drug: placebo

• Registration Number: NCT00622193
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2008-02-12
• Study First Submitted QC: 2008-02-12
• Study First Posted: 2008-02-22
• Study Start: 2008-03
• Primary Completion: 2009-12
• Study Completion: 2009-12
• Disposition First Submitted: 2011-06-08
• Disposition First Submitted QC: 2011-06-08
• Disposition First Posted: 2011-06-23
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-12
• Last Update Posted: 2017-04-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 228

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1 Active 50 mg	anamorelin HCl	-
2 Active 100 mg	anamorelin HCl	-
3 Placebo	placebo	-

Primary Outcome Measures

Name	Time	Method
Hand grip strength and body weight	Twelve weeks

Secondary Outcome Measures

Name	Time	Method
Quality of Life and Biomarker	Twelve weeks

Trial Locations

Locations (31)

University of Arkansas for Medical Sciences; 🇺🇸 Little Rock, Arkansas, United States

Osler Medical; 🇺🇸 Melbourne, Florida, United States

Augusta Oncology Associates; 🇺🇸 Augusta, Georgia, United States

South Georgia Medical Center; 🇺🇸 Valdosta, Georgia, United States

Investigative Clinical Research of Indiana; 🇺🇸 Indianapolis, Indiana, United States

John Hopkins University; 🇺🇸 Baltimore, Maryland, United States

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States

Dana Farber Cancer Center; 🇺🇸 Boston, Massachusetts, United States

Caritas St. Elizabeth's Medical Center; 🇺🇸 Boston, Massachusetts, United States

Beth Israel Deaconess Medical Center; 🇺🇸 Boston, Massachusetts, United States

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