Carcinoma, Non-Small-Cell Lung
Conditions
Keywords
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.
Interventions
DRUGanamorelin HCl
50 mg tablet
DRUGplacebo
placebo tablet
Sponsors
Helsinn Therapeutics (U.S.), Inc
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Hand grip strength and body weight | Twelve weeks |
Secondary
| Measure | Time frame |
|---|---|
| Quality of Life and Biomarker | Twelve weeks |
Countries
India, United States
Outcome results
None listed