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

April 12, 2017 updated by: Helsinn Therapeutics (U.S.), Inc

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

228

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
      • Bhopal, India
        • Jawaharlal Nehru Cancer Hospital and Research Centre
      • Chennai, India
        • Kamakshi Memorial Hospital
      • Delhi, India
        • Dharamshila Cancer Hospital and Research Center
      • Jaipur, India
        • Bhagwan Mahaveer Cancer Hospital and Resaerch Center
      • Jaipur, India
        • Birla Cancer Centre SMS Medical College Hospital
      • Maharashtra, India
        • Kodlikeri Memorial Hospital
      • Mumbai, India
        • Jaslok Hospital and Research Centre
      • Mumbai Naka, Nasik, India
        • Shatabdi Super Speciality Hospital
    • Bihar
      • Patna, Bihar, India
        • Regional Cancer Centre Indira Gandhi Institute of Medical Sciences
    • Maharashtra
      • Nagpur, Maharashtra, India
        • Cancer Clinic 208
      • Pune, Maharashtra, India
        • Noble Hospital
      • Pune, Maharashtra, India
        • Ruby Hall Clinic
      • Thane, Maharashtra, India
        • Kaushalya Medical Foundation Trust Hospital
    • Rajasthan
      • Jaipur, Rajasthan, India
        • Searoc Cancer Center
  • United States
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • University of Arkansas for Medical Sciences
    • Florida
      • Melbourne, Florida, United States, 32901
        • Osler Medical
    • Georgia
      • Augusta, Georgia, United States, 30901
        • Augusta Oncology Associates
      • Valdosta, Georgia, United States, 31602
        • South Georgia Medical Center
    • Indiana
      • Indianapolis, Indiana, United States, 46260
        • Investigative Clinical Research of Indiana
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • John Hopkins University
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Beth Israel Deaconess Medical Center
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital
      • Boston, Massachusetts, United States, 02135
        • Caritas St. Elizabeth's Medical Center
      • Boston, Massachusetts, United States, 02115
        • Dana Farber Cancer Center
    • Mississippi
      • Corinth, Mississippi, United States, 38834
        • The West Clinic
      • Southaven, Mississippi, United States, 38671
        • The West Clinic
    • Missouri
      • St Louis, Missouri, United States, 63110
        • Washington University School of Medicine
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke University Medical Center
    • South Carolina
      • Hilton Head Island, South Carolina, United States, 29926
        • South Carolina Cancer Specialists
    • Tennessee
      • Memphis, Tennessee, United States, 38120
        • The West Clinic
    • Texas
      • Houston, Texas, United States, 77030
        • The Methodist Hospital Research Institute
      • Houston, Texas, United States, 77030
        • Baylor College of Medicine/VAMC
    • Washington
      • Puyallup, Washington, United States, 98372
        • North West Medical Specialties, PLLC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: 3 Placebo
Drug: placebo
placebo tablet
Experimental: 1 Active 50 mg
Drug: anamorelin HCl
50 mg tablet
Other Names:
  • ST-1291
Drug: anamorelin HCl
100 mg tablet
Other Names:
  • ST-1291
Experimental: 2 Active 100 mg
Drug: anamorelin HCl
50 mg tablet
Other Names:
  • ST-1291
Drug: anamorelin HCl
100 mg tablet
Other Names:
  • ST-1291

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Hand grip strength and body weight
Time Frame: Twelve weeks
Twelve weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Quality of Life and Biomarker
Time Frame: Twelve weeks
Twelve weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Helsinn Therapeutics (U.S.), Inc

Investigators

  • Study Director: Jennifer Temel, MD, Massachusetts General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2008

Primary Completion (Actual)

December 1, 2009

Study Completion (Actual)

December 1, 2009

Study Registration Dates

First Submitted

February 12, 2008

First Submitted That Met QC Criteria

February 12, 2008

First Posted (Estimate)

February 22, 2008

Study Record Updates

Last Update Posted (Actual)

April 14, 2017

Last Update Submitted That Met QC Criteria

April 12, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ST-ANAM-207

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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