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Anamorelin Study for Advanced Pancreatic Cancer

NCT04844970 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 4

Last updated 2025-11-17

Study results available
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Summary

Multicenter, double-blind, randomized, placebo-controlled study to evaluate the efficacy and safety of anamorelin HCl. Approximately 100 subjects with advanced PDAC and cachexia will be randomized 1:1 to anamorelin HCl 100 mg or placebo, taken orally once daily (QD) for a total of 25 weeks. Subjects will be instructed to take the study drug at least 1 hour before their first meal of the day

Conditions

Interventions

DRUG

Anamorelin Hydrochloride

Anamorelin HCl is an orally-active selective ghrelin receptor agonist which has shown anabolic and appetite-stimulating effects.

DRUG

Placebo

Anamorelin placebo

Sponsors & Collaborators

  • Helsinn Healthcare SA

    collaborator INDUSTRY

  • Quartesian LLC

    collaborator UNKNOWN

  • Lahey Clinic

    lead OTHER

Principal Investigators

  • Keith Stuart · Lahey Hospital & Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-04-01
Primary Completion
2023-11-07
Completion
2023-11-07
FDA Drug
Yes

Countries

  • United States

Study Locations

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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 NCT04844970 on ClinicalTrials.gov