Anamorelin HCl in the Treatment of Non-Small Cell Lung Cancer-Cachexia (NSCLC-C): An Extension Study (ROMANA 3)
The administration of Anamorelin HCl in patients with Non-Small Cell Lung Cancer-Cachexia (NSCLC-C) is expected to increase appetite, lean body mass, weight gain, and muscle strength.
Study InterventionsAnamorelin HCl, PlaceboPrimary EndpointsPercentage of Participants With Treatment-emergent Adverse EventsStudy Period2011-07 → 2015-02 Anamorelin Study for Advanced Pancreatic Cancer
Multicenter, double-blind, randomized, placebo-controlled study to evaluate the efficacy and safety of anamorelin HCl. Approximately 100 subjects with advanced PDAC and cachexia will be randomized 1:1 to anamorelin HCl 100 mg or placebo, taken orally once daily (QD) for a total of 25 weeks. Subjects will be instructed to take the study drug at least 1 hour before their first meal of the day
Study InterventionsAnamorelin Hydrochloride, PlaceboPrimary EndpointsPercent Weight Change From Baseline to Week 25Study Period2023-04-01 → 2023-11-07 Dose Range Study of Anamorelin in Patients With Non-small Cell Lung Cancer
The purpose of this study is to evaluate doses of anamorelin for safety and efficacy in patients with non-small cell lung cancer.
Study Interventionsanamorelin HCl, anamorelin HCl, placeboPrimary EndpointsHand grip strength and body weightStudy Period2008-03 → 2009-12 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 follows: Do patients who receive anamorelin HCl gain more body weight and show more improvement in anor
Study InterventionsAnamorelin Hydrochloride, Placebo Oral TabletPrimary EndpointsMean Change From Baseline in Body Weight Over 12 Weeks; Mean Change From Baseline in 5-item Anorexia Symptom Subscale (5-IASS) Over 12 WeeksStudy Period2019-03-05 → 2023-02-11 Safety and Efficacy of Anamorelin HCl in Patients With Non-Small Cell Lung Cancer-Cachexia (ROMANA 2)
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 InterventionsAnamorelin HCl, PlaceboPrimary EndpointsChange in Lean Body Mass; Change in Handgrip StrengthStudy Period2011-07 → 2015-02 Anamorelin Hydrochloride in Reducing Anorexia in Patients With Advanced Non-small Cell Lung Cancer
This phase II/III trial studies how well anamorelin hydrochloride works in reducing anorexia in patients with non-small cell lung cancer that has spread to other places in the body. Anamorelin hydrochloride may help to improve patients' appetite in order to stop weight loss.
Study InterventionsAnamorelin Hydrochloride, Placebo, Questionnaire AdministrationPrimary EndpointsTo reach thematic saturation by qualitatively examining experiences related to anorexia at the baseline in advanced lung cancer patients with anorexia/cachexia receiving either oral Anamorelin 100 mg or placebo.Study Period2018-11-27 → 2026-12-31 Anamorelin Hydrochloride, Physical Activity, and Nutritional Counseling in Decreasing Cancer-Related Fatigue in Patients With Incurable Metastatic or Recurrent Solid Tumors
This phase II trial studies how well anamorelin hydrochloride, physical activity, and nutritional counseling work in decreasing cancer-related fatigue in patients with incurable solid tumors that have spread to other parts of the body or have come back. Anamorelin hydrochloride, physical activity, and nutritional counseling may help to decrease cancer-related fatigue in patients with solid tumors.
Study InterventionsAnamorelin Hydrochloride, Exercise Intervention, Laboratory Biomarker AnalysisPrimary EndpointsFunctional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F)Study Period2017-02-08 → 2026-02-28 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 follows: Do patients who receive anamorelin HCl gain more body weight and show more improvement in anor
Study Interventionsanamorelin HCl, Placebo Oral TabletPrimary EndpointsMean Change From Baseline in Body Weight Over 12 Weeks; Mean Change From Baseline in 5-item Anorexia Symptom Subscale (5-IASS) Over 12 WeeksStudy Period2019-05-06 → 2022-12-27 Safety and Efficacy of Anamorelin HCl in Patients With Non-Small Cell Lung Cancer-Cachexia (ROMANA 1)
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 InterventionsAnamorelin HCl, PlaceboPrimary EndpointsChange in Lean Body Mass; Change in Handgrip StrengthStudy Period2011-07 → 2015-02 The Role of Ghrelin in Cancer Cachexia
Cancer is often coupled with a condition called cachexia. In this condition, individuals continue to lose weight and lean body mass, which means their muscles are getting smaller and weaker. Studies have shown that cancer patients who are losing weight often are responding poorly to chemotherapy, are at greater risk of infection and have a reduced life expectancy. Also, people may not want to eat.
Study InterventionsAnamorelin HCl, PlaceboPrimary EndpointsTotal Body Potassium.Study Period2012-06 → 2016-03