Dose Range Study of Anamorelin in Patients With Non-small Cell Lung Cancer
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
1 other identifier
interventional
228
2 countries
33
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Mar 2008
33 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 12, 2008
CompletedFirst Posted
Study publicly available on registry
February 22, 2008
CompletedStudy Start
First participant enrolled
March 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2009
CompletedApril 14, 2017
April 1, 2017
1.8 years
February 12, 2008
April 12, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Hand grip strength and body weight
Twelve weeks
Secondary Outcomes (1)
Quality of Life and Biomarker
Twelve weeks
Study Arms (3)
1 Active 50 mg
EXPERIMENTAL2 Active 100 mg
EXPERIMENTAL3 Placebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- stage IIIB or IV NSCLC
- eligible for treatment of NSCLC with paclitaxel and carboplatin +/- bevacizumab
You may not qualify if:
- mixed large and small cell histologies for lung cancer
- significant obesity, BMI \> 30
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (33)
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205, United States
Osler Medical
Melbourne, Florida, 32901, United States
Augusta Oncology Associates
Augusta, Georgia, 30901, United States
South Georgia Medical Center
Valdosta, Georgia, 31602, United States
Investigative Clinical Research of Indiana
Indianapolis, Indiana, 46260, United States
John Hopkins University
Baltimore, Maryland, 21287, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Dana Farber Cancer Center
Boston, Massachusetts, 02115, United States
Caritas St. Elizabeth's Medical Center
Boston, Massachusetts, 02135, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215, United States
The West Clinic
Corinth, Mississippi, 38834, United States
The West Clinic
Southaven, Mississippi, 38671, United States
Washington University School of Medicine
St Louis, Missouri, 63110, United States
Duke University Medical Center
Durham, North Carolina, 27710, United States
South Carolina Cancer Specialists
Hilton Head Island, South Carolina, 29926, United States
The West Clinic
Memphis, Tennessee, 38120, United States
Baylor College of Medicine/VAMC
Houston, Texas, 77030, United States
The Methodist Hospital Research Institute
Houston, Texas, 77030, United States
North West Medical Specialties, PLLC
Puyallup, Washington, 98372, United States
Regional Cancer Centre Indira Gandhi Institute of Medical Sciences
Patna, Bihar, India
Cancer Clinic 208
Nagpur, Maharashtra, India
Noble Hospital
Pune, Maharashtra, India
Ruby Hall Clinic
Pune, Maharashtra, India
Kaushalya Medical Foundation Trust Hospital
Thane, Maharashtra, India
SEAROC Cancer Center
Jaipur, Rajasthan, India
Jawaharlal Nehru Cancer Hospital and Research Centre
Bhopal, India
Kamakshi Memorial Hospital
Chennai, India
Dharamshila Cancer Hospital and Research Center
Delhi, India
Bhagwan Mahaveer Cancer Hospital and Resaerch Center
Jaipur, India
Birla Cancer Centre SMS Medical College Hospital
Jaipur, India
Kodlikeri Memorial Hospital
Maharashtra, India
Jaslok Hospital and Research Centre
Mumbai, India
Shatabdi Super Speciality Hospital
Mumbai Naka, Nasik, India
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Jennifer Temel, MD
Massachusetts General Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 12, 2008
First Posted
February 22, 2008
Study Start
March 1, 2008
Primary Completion
December 1, 2009
Study Completion
December 1, 2009
Last Updated
April 14, 2017
Record last verified: 2017-04