- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01387269
Safety and Efficacy of Anamorelin HCl in Patients With Non-Small Cell Lung Cancer-Cachexia (ROMANA 1)
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
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
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Brest, Belarus
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Lesnoy, Belarus
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Minsk, Belarus
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Antwerpen, Belgium
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Brussels, Belgium
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Genk, Belgium
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Liege, Belgium
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Alberta
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Edmonton, Alberta, Canada
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Ontario
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Sault Ste. Marie, Ontario, Canada
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Toronto, Ontario, Canada
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Quebec
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Montreal, Quebec, Canada
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Benesov, Czechia
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Brno, Czechia
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Hlucin, Czechia
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Liberec, Czechia
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Nymburk, Czechia
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Lyon Cedex, France
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Villejuif cedex, France
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Berlin, Germany
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Grosshansdorf, Germany
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Halle, Germany
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Minden, Germany
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Budapest, Hungary
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Placenza, Italy
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Rozzano, Italy
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Amsterdam, Netherlands
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Goes, Netherlands
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Maastricht, Netherlands
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Nieuwegein, Netherlands
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Grudziadz, Poland
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Katowice, Poland
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Krakow, Poland
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Lublin, Poland
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Ekaterinburg, Russian Federation
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St. Petersburg, Russian Federation
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Belgrade, Serbia
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Sremska Kamenica, Serbia
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Golnik, Slovenia
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Ljubljana, Slovenia
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Barcelona, Spain
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Cordoba, Spain
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Sevilla, Spain
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Valencia, Spain
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Dnipropetrovsk, Ukraine
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Donetsk, Ukraine
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Kharkiv, Ukraine
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Kyiv, Ukraine
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Zaporizhzhya, Ukraine
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California
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Fullerton, California, United States
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Glendale, California, United States
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La Jolla, California, United States
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Riverside, California, United States
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Florida
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Orange City, Florida, United States
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Illinois
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Quincy, Illinois, United States
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Indiana
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Indianapolis, Indiana, United States
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Kentucky
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Louisville, Kentucky, United States
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Massachusetts
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Boston, Massachusetts, United States
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New York
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Northport, New York, United States
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Ohio
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Cincinnati, Ohio, United States
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Texas
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Houston, Texas, United States
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Documented diagnosis of unresectable Stage III or Stage IV NSCLC
- Patients may be receiving maintenance chemotherapy
- Patients planning to initiate a new chemotherapy and/or radiation therapy regimen may do so only within ± 14 days of randomization
- Patients may have completed a chemotherapy and/or radiation therapy and/or have no plan to initiate a new regimen within 12 weeks from randomization; at least 14 days must elapse from the completion of the chemotherapy and/or radiation therapy prior to randomization
- Involuntary weight loss of ≥5% body weight within 6 months prior to screening or a screening body mass index (BMI) <20 kg/m2
- Body mass index ≤30 kg/m2
- Life expectancy of >4 months at time of screening
- ECOG performance status ≤2
- Adequate hepatic function, defined as AST and ALT levels ≤5 x upper limit of normal
- Adequate renal function, defined as creatinine ≤2 x upper limit of normal, or calculated creatinine clearance >30 ml/minute
- Ability to understand and comply with the procedures for the HGS evaluation
- If a woman of childbearing potential or a fertile man, he/she must agree to use an effective form of contraception during the study and for 30 days following the last dose of study drug (an effective form of contraception is abstinence, a hormonal contraceptive, or a double-barrier method)
- Must be willing and able to give signed informed consent and, in the opinion of the Investigator, to comply with the protocol tests and procedures
Exclusion Criteria:
- Other forms of lung cancer (e.g., small cell, mesothelioma)
- Women who are pregnant or breast-feeding
- Known HIV, hepatitis (B&C), or active tuberculosis
- Had major surgery (central venous access placement and tumor biopsies are not considered major surgery) within 4 weeks prior to randomization; patients must be well recovered from acute effects of surgery prior to screening; patients should not have plans to undergo major surgical procedures during the treatment period
- Currently taking prescription medications intended to increase appetite or treat weight loss; these include, but are not limited to, testosterone, androgenic compounds, megestrol acetate, methylphenidate, and dronabinol
- Inability to readily swallow oral tablets; patients with severe gastrointestinal disease (including esophagitis, gastritis, malabsorption, or obstructive symptoms) or intractable or frequent vomiting are excluded
- Has an active, uncontrolled infection
- Has uncontrolled diabetes mellitus
- Has untreated clinically relevant hypothyroidism
- Has known or symptomatic brain metastases
- Receiving strong CYP3A4 inhibitors within 14 days of randomization
- Receiving tube feedings or parenteral nutrition (either total or partial); patients must have discontinued these treatments for at least 6 weeks prior to Day 1, and throughout the study duration
- Other clinical diagnosis, ongoing or intercurrent illness that in the Investigator's opinion would prevent the patient's participation
- Has had previous exposure to Anamorelin HCl
- Patients actively receiving a concurrent investigational agent
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Placebo Comparator: Placebo
Placebo tablets identical in appearance to active tablets; oral administration once daily
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Placebo tablets identical in appearance to active tablets; oral administration QD for 12 weeks, at least 1 hour before meal
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Experimental: 100 mg QD
Anamorelin HCL 100 mg will be administered daily
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Anamorelin HCl will be orally administered daily at least one hour before meal
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Change in Lean Body Mass
Time Frame: Change in Lean Body Mass from Baseline Over 12 Weeks
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Change in Lean Body Mass (LBM) from baseline over 12 weeks for the ITT Population.
Change from baseline over 12 weeks was defined as the average of the change from baseline at Week 6 and the change from baseline at Week 12.
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Change in Lean Body Mass from Baseline Over 12 Weeks
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Change in Handgrip Strength
Time Frame: Change in Handgrip Strength of the Non-Dominant Hand from Baseline Over 12 Weeks
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Change in Handgrip Strength (HGS) of the non-dominant hand from baseline over 12 weeks for the ITT Population.
Change from baseline over 12 weeks was defined as the average of the change from baseline at Week 6 and the change from baseline at Week 12.
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Change in Handgrip Strength of the Non-Dominant Hand from Baseline Over 12 Weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Change in A/CS Domain Score
Time Frame: Change in FAACT A/CS Domain Score from Baseline Over 12 Weeks
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The Functional Assessment of Anorexia/Cachexia Treatment (FAACT) Additional Concerns Subscale (A/CS domain) is a 12-item scale that is part of the Functional Assessment of Chronic Illness Therapy (FACIT) Measurement System. Each item is answered on a 5-point Likert scale ranging from 0 (not at all) to 4 (very much). The 12-items are summed together to obtain the domain score. Note that negatively phrased questions are reverse scored so that higher scores always represent improvement/less symptom burden. The total possible score for the A/CS domain ranges from 0 (worst) to 48 (best). |
Change in FAACT A/CS Domain Score from Baseline Over 12 Weeks
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Change in FACIT-F Fatigue Domain Score
Time Frame: Change in FACIT-F Fatigue Domain Score from Baseline Over 12 Weeks
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The Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) fatigue domain is a 13-item scale that is part of the Functional Assessment of Chronic Illness Therapy (FACIT) Measurement System. Each item is answered on a 5-point Likert scale ranging from 0 (not at all) to 4 (very much). The 13-items are summed together to obtain the domain score. Note that negatively phrased questions are reverse scored so that higher scores always represent improvement/less symptom burden. The total possible score for the FACIT-F fatigue domain ranges from 0 (worst) to 52 (best). |
Change in FACIT-F Fatigue Domain Score from Baseline Over 12 Weeks
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Change in Body Weight
Time Frame: Change in Body Weight from Baseline Over 12 Weeks
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Change in body weight (BW) from baseline overall (i.e., over 12 weeks) for the MITT Population.
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Change in Body Weight from Baseline Over 12 Weeks
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Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Currow D, Temel JS, Abernethy A, Milanowski J, Friend J, Fearon KC. ROMANA 3: a phase 3 safety extension study of anamorelin in advanced non-small-cell lung cancer (NSCLC) patients with cachexia. Ann Oncol. 2017 Aug 1;28(8):1949-1956. doi: 10.1093/annonc/mdx192.
- Temel JS, Abernethy AP, Currow DC, Friend J, Duus EM, Yan Y, Fearon KC. 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. Lancet Oncol. 2016 Apr;17(4):519-531. doi: 10.1016/S1470-2045(15)00558-6. Epub 2016 Feb 20.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Metabolic Diseases
- Respiratory Tract Diseases
- Neoplasms
- Lung Diseases
- Neoplasms by Site
- Nutrition Disorders
- Body Weight
- Respiratory Tract Neoplasms
- Thoracic Neoplasms
- Carcinoma, Bronchogenic
- Bronchial Neoplasms
- Body Weight Changes
- Emaciation
- Weight Loss
- Lung Neoplasms
- Carcinoma, Non-Small-Cell Lung
- Wasting Syndrome
- Cachexia
Other Study ID Numbers
- HT-ANAM-301
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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