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Pilot Clinical Trial of Repeated Doses of Macimorelin to Assess Safety and Efficacy in Patients With Cancer Cachexia

NCT01614990 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2024-03-20

Study results available
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Summary

The purpose of this study is to evaluate the safety and efficacy of repeated oral administration of macimorelin at different doses daily for 1 week for the treatment of cancer cachexia.

Conditions

  • Cancer Cachexia

Interventions

DRUG

Macimorelin

Subjects will receive macimorelin (1 mg/kg) and matching placebo (Powerade®) daily for 7 days.

DRUG

Placebo

placebo (Powerade®) daily for 7 days.

Sponsors & Collaborators

  • VA Office of Research and Development

    collaborator FED

  • Baylor College of Medicine

    collaborator OTHER

  • AEterna Zentaris

    collaborator INDUSTRY

  • Garcia, Jose M., MD, PhD

    lead INDIV

Principal Investigators

  • Jose M Garcia, MD, PhD · University of Washington and Veterans Affairs Puget Sound Health Care System

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-05-31
Primary Completion
2020-07-31
Completion
2021-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

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 NCT01614990 on ClinicalTrials.gov