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A Study to Evaluate the Efficacy and Safety of Anamorelin HCl for the Treatment of Malignancy Associated Weight Loss and Anorexia in Adult Patients With Advanced Non-Small Cell Lung Cancer (NSCLC)

NCT03743051 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 318

Last updated 2024-06-26

Study results available
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Summary

The goal of this clinical trial was to compare the efficacy and safety of anamorelin HCl (the investigational drug) to that of placebo (tablet with no drug) in patients with advanced non-small cell lung cancer and cachexia (cancer-related weight loss). The main question it aimed to answer was as follows: Do patients who receive anamorelin HCl gain more body weight and show more improvement in anorexia symptoms than those who receive placebo.

Approximately 316 patients were to be enrolled in the study. Of these patients, an equal number were to be assigned to each treatment group (anamorelin HCl or placebo). Participants were to take their assigned study drug by mouth once daily for a total of 24 weeks. During this treatment period, the patients were to visit the clinical study site every 3 weeks for health and other study-related assessments. Two weeks after the last treatment, patients were to receive a follow-up phone call.

Conditions

  • Cachexia; Cancer
  • Non Small Cell Lung Cancer

Interventions

DRUG

Anamorelin Hydrochloride

100 mg anamorelin HCl (administered as 100 mg tablets in the fasted condition)

DRUG

Placebo Oral Tablet

Placebo (administered as matching placebo tablets in the fasted condition)

Sponsors & Collaborators

  • Helsinn Healthcare SA

    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
2019-03-05
Primary Completion
2023-02-11
Completion
2023-02-11
FDA Drug
Yes

Countries

  • United States
  • Bulgaria
  • Hungary
  • Italy
  • Romania
  • Russia
  • Serbia

Study Locations

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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 NCT03743051 on ClinicalTrials.gov