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

Sponsor
Helsinn Therapeutics (U.S.), Inc (Industry)
Overall Status
Completed
CT.gov ID
NCT00622193
Collaborator
(none)
228
Enrollment
33
Locations
3
Arms
21
Duration (Months)
6.9
Patients Per Site
0.3
Patients Per Site Per Month

Study Details

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
  • Drug: anamorelin HCl
  • 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
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 :
Mar 1, 2008
Actual Primary Completion Date :
Dec 1, 2009
Actual Study Completion Date :
Dec 1, 2009

Arms and Interventions

Arm Intervention/Treatment
Experimental: 1 Active 50 mg

Drug: anamorelin HCl
50 mg tablet
Other Names:
  • ST-1291

    		•
    Experimental: 2 Active 100 mg

    Drug: anamorelin HCl
    100 mg tablet
    Other Names:
  • ST-1291

    		•
    Placebo Comparator: 3 Placebo

    Drug: placebo
    placebo tablet

    Outcome Measures

    Primary Outcome Measures

    1. Hand grip strength and body weight [Twelve weeks]

    Secondary Outcome Measures

    1. Quality of Life and Biomarker [Twelve weeks]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 85 Years
    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

    Locations

    Site City State Country Postal Code
    1 University of Arkansas for Medical Sciences Little Rock Arkansas United States 72205
    2 Osler Medical Melbourne Florida United States 32901
    3 Augusta Oncology Associates Augusta Georgia United States 30901
    4 South Georgia Medical Center Valdosta Georgia United States 31602
    5 Investigative Clinical Research of Indiana Indianapolis Indiana United States 46260
    6 John Hopkins University Baltimore Maryland United States 21287
    7 Massachusetts General Hospital Boston Massachusetts United States 02114
    8 Dana Farber Cancer Center Boston Massachusetts United States 02115
    9 Caritas St. Elizabeth's Medical Center Boston Massachusetts United States 02135
    10 Beth Israel Deaconess Medical Center Boston Massachusetts United States 02215
    11 The West Clinic Corinth Mississippi United States 38834
    12 The West Clinic Southaven Mississippi United States 38671
    13 Washington University School of Medicine St Louis Missouri United States 63110
    14 Duke University Medical Center Durham North Carolina United States 27710
    15 South Carolina Cancer Specialists Hilton Head Island South Carolina United States 29926
    16 The West Clinic Memphis Tennessee United States 38120
    17 Baylor College of Medicine/VAMC Houston Texas United States 77030
    18 The Methodist Hospital Research Institute Houston Texas United States 77030
    19 North West Medical Specialties, PLLC Puyallup Washington United States 98372
    20 Regional Cancer Centre Indira Gandhi Institute of Medical Sciences Patna Bihar India
    21 Cancer Clinic 208 Nagpur Maharashtra India
    22 Noble Hospital Pune Maharashtra India
    23 Ruby Hall Clinic Pune Maharashtra India
    24 Kaushalya Medical Foundation Trust Hospital Thane Maharashtra India
    25 SEAROC Cancer Center Jaipur Rajasthan India
    26 Jawaharlal Nehru Cancer Hospital and Research Centre Bhopal India
    27 Kamakshi Memorial Hospital Chennai India
    28 Dharamshila Cancer Hospital and Research Center Delhi India
    29 Bhagwan Mahaveer Cancer Hospital and Resaerch Center Jaipur India
    30 Birla Cancer Centre SMS Medical College Hospital Jaipur India
    31 Kodlikeri Memorial Hospital Maharashtra India
    32 Shatabdi Super Speciality Hospital Mumbai Naka, Nasik India
    33 Jaslok Hospital and Research Centre Mumbai India

    Sponsors and Collaborators

    • Helsinn Therapeutics (U.S.), Inc

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Helsinn Therapeutics (U.S.), Inc
    ClinicalTrials.gov Identifier:
    NCT00622193
    Other Study ID Numbers:
    • ST-ANAM-207
    First Posted:
    Feb 22, 2008
    Last Update Posted:
    Apr 14, 2017
    Last Verified:
    Apr 1, 2017
    Keywords provided by Helsinn Therapeutics (U.S.), Inc
    NSCLC
    Additional relevant MeSH terms:
    Carcinoma, Non-Small-Cell Lung

    Study Results

    No Results Posted as of Apr 14, 2017