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Anamorelin HCl

DRUG6 trials

Sponsors

Helsinn Therapeutics (U.S.), Inc, VA Office of Research and Development, Helsinn Healthcare SA

Conditions

CachexiaCachexia; CancerCancer CachexiaCarcinoma, Non-Small-Cell LungNon Small Cell Lung CancerNon-Small Cell Lung Cancer

Phase 2

Dose Range Study of Anamorelin in Patients With Non-small Cell Lung Cancer
CompletedNCT00622193
Helsinn Therapeutics (U.S.), IncCarcinoma, Non-Small-Cell Lung
Start: 2008-03-31End: 2009-12-31Updated: 2017-04-14
The Role of Ghrelin in Cancer Cachexia
TerminatedNCT01505764
VA Office of Research and DevelopmentCancer Cachexia
Start: 2012-06-30End: 2016-03-31Updated: 2018-07-17

Phase 3

Safety and Efficacy of Anamorelin HCl in Patients With Non-Small Cell Lung Cancer-Cachexia (ROMANA 2)
CompletedNCT01387282
Helsinn Therapeutics (U.S.), IncCachexia, Non-Small Cell Lung Cancer
Start: 2011-07-31End: 2015-02-28Updated: 2017-10-27
Safety and Efficacy of Anamorelin HCl in Patients With Non-Small Cell Lung Cancer-Cachexia (ROMANA 1)
CompletedNCT01387269
Helsinn Therapeutics (U.S.), IncCachexia, Non-Small Cell Lung Cancer
Start: 2011-07-31End: 2015-02-28Updated: 2017-10-27
Anamorelin HCl in the Treatment of Non-Small Cell Lung Cancer-Cachexia (NSCLC-C): An Extension Study (ROMANA 3)
CompletedNCT01395914
Helsinn Therapeutics (U.S.), IncCachexia, Non-Small Cell Lung Cancer
Start: 2011-07-31End: 2015-02-28Updated: 2017-09-14
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)
CompletedNCT03743064
Helsinn Healthcare SACachexia; Cancer, Non Small Cell Lung Cancer
Start: 2019-05-06End: 2022-12-27Updated: 2024-06-26

Related Papers

Anamorelin Efficacy in Non–Small‐Cell Lung Cancer Patients With Cachexia: Insights From ROMANA 1 and ROMANA 2
Journal of Cachexia Sarcopenia and Muscle2025-02-0111 citations
Phase II, double blind, placebo controlled, multi-site study to evaluate the safety, feasibility and desirability of conducting a phase III study of anamorelin for anorexia in people with small cell lung cancer: A study protocol (LUANA trial)
PLoS ONE2023-05-174 citations
Body weight (BW) response timing to anamorelin (ANAM) in advanced non–small cell lung cancer (NSCLC)–associated cachexia.
Journal of Clinical Oncology2022-06-01
ROMANA 3: a phase 3 safety extension study of anamorelin in advanced non-small-cell lung cancer (NSCLC) patients with cachexia.
2017-08-01124 citations
Body weight response with anamorelin in advanced non-small cell lung cancer (NSCLC) patients with anorexia/cachexia: Pooled analysis of two phase III trials.
Journal of Clinical Oncology2017-05-203 citations
Efficacy of anamorelin in cachectic patients with non-small cell lung cancer (NSCLC) and low BMI (&lt; 20 kg/m<sup>2</sup>): Post-hoc analysis of two phase III studies.
Journal of Clinical Oncology2016-10-092 citations
Anamorelin in cachectic patients with non-small cell lung cancer (NSCLC) and low BMI (&lt; 20 kg/m<sup>2</sup>): A pooled efficacy data analysis of two phase 3 studies.
Journal of Clinical Oncology2016-05-201 citations
Anamorelin in patients with non-small-cell lung cancer and cachexia (ROMANA 1 and ROMANA 2): results from two randomised, double-blind, phase 3 trials.
2016-02-20450 citations
Anamorelin in patients with advanced non-small cell lung cancer and cachexia: Results from the phase III studies ROMANA 1 and 2.
Journal of Clinical Oncology2015-10-105 citations
Phase III trials of anamorelin in patients with advanced non-small cell lung cancer (NSCLC) and cachexia (ROMANA 1 and 2).
Journal of Clinical Oncology2015-05-208 citations
A safety extension study of anamorelin in advanced non-small cell lung cancer patients with cachexia: ROMANA 3.
Journal of Clinical Oncology2015-05-206 citations
Subgroup analysis of ECOG2 patients from ROMANA 2: A phase III study of anamorelin in NSCLC patients with cachexia.
Journal of Clinical Oncology2014-11-014 citations
Brief versions of the FACIT-fatigue and FAACT subscales for patients with non-small cell lung cancer cachexia.
2014-10-2919 citations
Brief versions of the FACIT-fatigue and FAACT subscales for patients with non-small cell lung cancer cachexia.
Journal of Clinical Oncology2014-10-20
Anamorelin for the treatment of cancer anorexia-cachexia: Baseline characteristics from three phase III clinical trials (the ROMANA program).
Journal of Clinical Oncology2014-05-201 citations
Evaluation of quality of life from a phase II study of anamorelin HCl in NSCLC patients.
Journal of Clinical Oncology2013-11-011 citations