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NCT03743064 · ClinicalTrials.gov registry record · Phase 3
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)
A Phase 3 study of Non-Small Cell Lung Cancer and Cachexia; Cancer, sponsored by Helsinn Healthcare.
- Completed
- Registry status
- Phase 3
- Development phase
- 318
- Enrollment target
- 20
- Study locations
NCT03743064: Completed Phase 3 study of Non-Small Cell Lung Cancer and Cachexia; Cancer, sponsored by Helsinn Healthcare.
NCT03743064 is a Phase 3 study of Non-Small Cell Lung Cancer and Cachexia; Cancer that has completed, run by Helsinn Healthcare. The registered enrollment target is 318 participants, below the 652-participant average among 454 other Non-Small Cell Lung Cancer trials with a reported enrollment target (51% lower). The trial reports 20 study locations across 15 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03743064, a Phase 3 study of Non-Small Cell Lung Cancer and Cachexia; Cancer, has completed, sponsored by Helsinn Healthcare.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 318 participants
- Enrollment target
- 20
- Study locations
Study 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.
Primary Outcome
This co-primary efficacy endpoint was mean change from baseline in body weight (kg) over 12 weeks in the anamorelin HCl group versus placebo group. Mean change was computed as sum of the changes from baseline over 12 weeks by the time of the last assessment (either week 12 or before in case of death), and then divided by the number of assessments (observed or imputed) from baseline up to the time of the last assessment.
Conditions Studied
Interventions
- DRUG Placebo Oral Tablet
- DRUG anamorelin HCl
Study Locations (20)
California
- Pacific Cancer Medical Center, Inc - Anaheim
- CBCC Global Research Inc - Bakersfield
- Compassionate Care Research Group, Inc., at Compassionate Cancer Care Medical Group, Inc. - Fountain Valley
- Marin Cancer Care - Greenbrae
New Jersey
- New Jersey Hematology Oncology Associates Inc - Brick
- Hunterdon Hematology Oncology LLC - Flemington
New York
- Hematology Oncology Center at Nyack Hospital - Nyack
- University of Rochester, Medical Center - Rochester
Arizona
- The University of Arizona Cancer Center - North Campus - Tucson
Connecticut
- Smilow Cancer Hospital at Yale-New Haven - Waterbury
Florida
- Bond & Steele Clinic P.A. - Winter Haven
Illinois
- Presence Infusion Care - Skokie
Iowa
- Siouxland Regional Cancer Center dba June E.Nylen Cancer Center - Sioux City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 318 participants |
| Start Date | 2019-05-06 |
| Est. Completion | 2022-12-27 |
| Phase | Phase 3 |
What the finished NCT03743064 record still lists
NCT03743064 is an interventional study that assigns participants to a tested intervention. The registered 318 participants enrollment target is mid-sized for trials with a published cap, below the 652-participant average among 454 other Non-Small Cell Lung Cancer trials with a reported enrollment target (51% lower).
The record links to 2 conditions, with Non-Small Cell Lung Cancer appearing as the primary indexed condition, and to 2 interventions - of which Placebo Oral Tablet is the first listed.
NCT03743064 names 20 study sites across 15 states, led by California, New Jersey, New York.
Frequently Asked Questions
What is clinical trial NCT03743064 about?
NCT03743064 is a clinical study titled "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)". 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 fol...
What is the current status of trial NCT03743064?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 318 participants. The study started on 2019-05-06. Estimated completion is 2022-12-27.
What conditions does trial NCT03743064 study?
This clinical trial studies the following conditions: Non-Small Cell Lung Cancer, Cachexia; Cancer.
What interventions are being tested in trial NCT03743064?
The interventions under investigation include: Placebo Oral Tablet (DRUG), anamorelin HCl (DRUG).
Who is sponsoring clinical trial NCT03743064?
This trial is sponsored by Helsinn Healthcare, which has 18 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03743064 being conducted?
This trial has 20 study locations across Arizona, California, Connecticut, Florida, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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318 117th of 454 higher than 337 of 454 other Non-Small Cell Lung Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Non-Small Cell Lung Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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