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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.
 
ClinicalTrials.gov Identifier: NCT00622193
Recruitment Status : Completed
First Posted : February 22, 2008
Last Update Posted : April 14, 2017
Sponsor:
Information provided by (Responsible Party):
Helsinn Therapeutics (U.S.), Inc

Tracking Information
First Submitted Date  ICMJE February 12, 2008
First Posted Date  ICMJE February 22, 2008
Last Update Posted Date April 14, 2017
Study Start Date  ICMJE March 2008
Actual Primary Completion Date December 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 12, 2008)
Hand grip strength and body weight [ Time Frame: Twelve weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 12, 2008)
Quality of Life and Biomarker [ Time Frame: Twelve weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Dose Range Study of Anamorelin in Patients With Non-small Cell Lung Cancer
Official Title  ICMJE 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
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Carcinoma, Non-Small-Cell Lung
Intervention  ICMJE
  • Drug: anamorelin HCl
    50 mg tablet
    Other Name: ST-1291
  • Drug: anamorelin HCl
    100 mg tablet
    Other Name: ST-1291
  • Drug: placebo
    placebo tablet
Study Arms  ICMJE
  • Experimental: 1 Active 50 mg
    Intervention: Drug: anamorelin HCl
  • Experimental: 2 Active 100 mg
    Intervention: Drug: anamorelin HCl
  • Placebo Comparator: 3 Placebo
    Intervention: Drug: placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 12, 2008)
228
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2009
Actual Primary Completion Date December 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE India,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00622193
Other Study ID Numbers  ICMJE ST-ANAM-207
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Helsinn Therapeutics (U.S.), Inc
Study Sponsor  ICMJE Helsinn Therapeutics (U.S.), Inc
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Jennifer Temel, MD Massachusetts General Hospital
PRS Account Helsinn Therapeutics (U.S.), Inc
Verification Date April 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP