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)
Public ClinicalTrials.gov record NCT03743064. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 3 Randomized, Double-Blind, Placebo-Controlled, Multicenter 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)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT03743064
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 318 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- May 5, 2019
- Primary completion
- Dec 26, 2022
- Completion
- Dec 26, 2022
- Last update posted
- Jun 25, 2024
2019 – 2022
United States locations
- U.S. sites
- 19
- U.S. states
- 14
- U.S. cities
- 19
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| The University of Arizona Cancer Center - North Campus | Tucson | Arizona | 85719 | — |
| Pacific Cancer Medical Center, Inc | Anaheim | California | 92801 | — |
| CBCC Global Research Inc | Bakersfield | California | 93309 | — |
| Compassionate Care Research Group, Inc., at Compassionate Cancer Care Medical Group, Inc. | Fountain Valley | California | 92708 | — |
| Marin Cancer Care | Greenbrae | California | 94904 | — |
| Smilow Cancer Hospital at Yale-New Haven | Waterbury | Connecticut | 06708 | — |
| Bond & Steele Clinic P.A. | Winter Haven | Florida | 33881 | — |
| Presence Infusion Care | Skokie | Illinois | 60077 | — |
| Siouxland Regional Cancer Center dba June E.Nylen Cancer Center | Sioux City | Iowa | 51101 | — |
| Cancer Center of Kansas | Wichita | Kansas | 67214 | — |
| Cancer and Hematology Centers of Western Michigan | Grand Rapids | Michigan | 49503 | — |
| Dartmouth-Hitchcock Medical Center | Lebanon | New Hampshire | 03756 | — |
| New Jersey Hematology Oncology Associates Inc | Brick | New Jersey | 08724 | — |
| Hunterdon Hematology Oncology LLC | Flemington | New Jersey | 08822 | — |
| Hematology Oncology Center at Nyack Hospital | Nyack | New York | 10960 | — |
| University of Rochester, Medical Center | Rochester | New York | 14642 | — |
| Duke Cancer Center | Durham | North Carolina | 27710 | — |
| Toledo Clinic Cancer Center-Toledo | Toledo | Ohio | 43623 | — |
| The University of Texas MD Anderson Cancer Center | Houston | Texas | 77030-4009 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 46 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03743064, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jun 25, 2024 · Synced Sep 5, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT03743064 live on ClinicalTrials.gov.