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Growth Hormone Secretagogue Receptor Agonist

anamorelin HCl for Non-Small Cell Lung Cancer

Phase 3

Waitlist Available

Research Sponsored by Helsinn Healthcare SA

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from baseline until week 12

Awards & highlights

Study Summary

This trial is testing a new drug to see if it can help people with cancer who have cachexia (a wasting syndrome). 316 people will be given the new drug or a placebo, and the effects will be monitored for 24 weeks.

Eligible Conditions

Non-Small Cell Lung Cancer
Cancer Cachexia

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from baseline until week 12

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from baseline until week 12

This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline until week 12 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Secondary outcome measures

5 item Anorexia Symptom Subscale

FAACT 12-item A/CS domain

FAACT total score

+2 more

Other outcome measures

Composite Clinical Response (CCR)

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: 100 mg anamorelin HClExperimental Treatment1 Intervention

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

Group II: PlaceboPlacebo Group1 Intervention

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

anamorelin HCl

2008

Completed Phase 3

~550

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Helsinn Healthcare SALead Sponsor

41 Previous Clinical Trials

9,257 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

When was the last time that anamorelin HCl was cleared by the FDA?

"There is existent clinical data affirming anamorelin HCl's safety, thus it was given a 3."

Answered by AI

Is anamorelin HCl a new medication?

"First appearing in 2017 at M D Anderson Cancer Center, anamorelin HCl has undergone 175 completed clinical trials. Out of the 6 active studies, many are based in Rochester, New york."

Answered by AI

Where are the places this research is being conducted?

"There are a total of 19 participating clinical trial sites, these include the University of Rochester Medical Center in Rochester, Duke Cancer Center in Durham, and Bond & Steele Clinic P.A. in Winter Haven, as well as 16 other locations."

Answered by AI

What are the researchers aiming to study in this clinical trial?

"According to the pharmaceutical company sponsoring this trial, Helsinn Healthcare SA, the primary outcome being measured is the length of time that patients experience a clinically meaningful benefit from treatment. This will be tracked over a 12-week period using the 5-item Anorexia Symptom Subscale. Additionally, this trial will measure secondary outcomes including FACIT-F (defined as mean change in FACIT-F), FAACT 12-item A/CS domain (defined as mean change in FAACT 12-item A/CS domain), and FAACT total score (defined as mean change in FAACT total score)."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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)

2018. "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)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03743064.