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Completed Phase 3 Interventional Results available

Safety and Efficacy of Anamorelin HCl in Patients With Non-Small Cell Lung Cancer-Cachexia (ROMANA 1)

ClinicalTrials.gov ID: NCT01387269

Public ClinicalTrials.gov record NCT01387269. 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.

ClinicalTrials.gov public records Last synced Oct 21, 2026, 12:43 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

Anamorelin HCl in the Treatment of Non-Small Cell Lung Cancer-Cachexia (NSCLC-C): A Randomized Double-Blind Placebo-Controlled Multicenter Phase III Study to Evaluate the Safety and Efficacy of Anamorelin HCl in Patients With NSCLC-C

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

The administration of Anamorelin in patients with Stage III-IV non-small cell lung cancer-cachexia (NSCLC-C) is expected to increase appetite, lean body mass, weight gain, and muscle strength.

Study identification

NCT ID
NCT01387269
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Enrollment
484 participants

Conditions and interventions

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
Jul 2011 (Type not available)
Primary completion
Jan 2014 (Actual)
Completion
Feb 2015 (Actual)
Last update posted
Oct 27, 2017

2011 – 2015

United States locations

U.S. sites
12
U.S. states
9
U.S. cities
12
Facility City State ZIP Site status
Not listed Fullerton California — —
Not listed Glendale California — —
Not listed La Jolla California — —
Not listed Riverside California — —
Not listed Orange City Florida — —
Not listed Quincy Illinois — —
Not listed Indianapolis Indiana — —
Not listed Louisville Kentucky — —
Not listed Boston Massachusetts — —
Not listed Northport New York — —
Not listed Cincinnati Ohio — —
Not listed Houston Texas — —

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 48 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT01387269, 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 Oct 27, 2017 · Synced Oct 21, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT01387269 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →