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Anamorelin HCl in the Treatment of Non-Small Cell Lung Cancer-Cachexia (NSCLC-C): An Extension Study (ROMANA 3)

NCT01395914 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 513

Last updated 2017-09-14

Study results available
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Summary

The administration of Anamorelin HCl in patients with Non-Small Cell Lung Cancer-Cachexia (NSCLC-C) is expected to increase appetite, lean body mass, weight gain, and muscle strength.

Conditions

Interventions

DRUG

Anamorelin HCl

DRUG

Placebo

Sponsors & Collaborators

  • Helsinn Therapeutics (U.S.), Inc

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-07-31
Primary Completion
2014-06-30
Completion
2015-02-28

Countries

  • United States
  • Australia
  • Belarus
  • Belgium
  • Canada
  • Czechia
  • France
  • Germany
  • Hungary
  • Israel
  • Italy
  • Poland
  • Russia
  • Serbia
  • Slovenia
  • Spain
  • Ukraine

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01395914 on ClinicalTrials.gov