CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 495 enrolled
Drug / intervention
Anamorelin HCl +1 moredrug
Likely dose
Anamorelin HCl 100 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01387282
NCT01387282Phase 3Completed

Anamorelin HCl in the Treatment of Non-Small Cell Lung Cancer-Cachexia (NSCLC-C): A Randomized Double-Blind Placebo-Controlled Multicenter Phase III Study to Evaluate the Safety and Efficacy of Anamorelin HCl in Patients With NSCLC-C

Helsinn Therapeutics (U.S.), Inc·interventional·Posted Jul 4, 2011·Updated Oct 27, 2017

In Brief

A Phase 3 clinical trial evaluating Anamorelin HCl and Placebo for Cachexia and Non-Small Cell Lung Cancer. Completed, enrolled 495 participants across 46 sites in 7 countries.

Detailed Summary

The administration of Anamorelin in patients with Stage III-IV non-small cell lung cancer-cachexia (NSCLC-C) is expected to increase appetite, lean body mass, weight gain, and muscle strength.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesAustralia, Hungary, Israel, Poland, Russia, United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedJul 4, 2011
Enrollment StartJul 1, 2011
Primary CompletionNov 1, 2013
Study CompletionFeb 1, 2015
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 15.0 years ago

Interventions

Anamorelin HCldrug

Anamorelin HCL 100 mg will be orally administered daily at least 1 hour prior to meal

Placebodrug

Placebo tablets identical in appearance to active tablets; oral administration QD for 12 weeks, at least 1 hour prior to meal before the first meal of the day.