Safety and Efficacy of Anamorelin HCl in Patients With Non-Small Cell Lung Cancer-Cachexia (ROMANA 2)
NCT ID: NCT01387282
Last Updated: 2017-10-27
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
495 participants
INTERVENTIONAL
2011-07-31
2015-02-28
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
100 mg QD
Investigational: Anamorelin HCl; 100 mg tablets; oral administration QD for 12 weeks, at least 1 hour before the first meal of the day.
Anamorelin HCl
Anamorelin HCL 100 mg will be orally administered daily at least 1 hour prior to meal
Placebo
Placebo tablets identical in appearance to active tablets; oral administration once daily
Placebo
Placebo tablets identical in appearance to active tablets; oral administration QD for 12 weeks, at least 1 hour prior to meal before the first meal of the day.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Anamorelin HCl
Anamorelin HCL 100 mg will be orally administered daily at least 1 hour prior to meal
Placebo
Placebo tablets identical in appearance to active tablets; oral administration QD for 12 weeks, at least 1 hour prior to meal before the first meal of the day.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Helsinn Therapeutics (U.S.), Inc
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Corona, California, United States
Fountain Valley, California, United States
Glendale, California, United States
Washington D.C., District of Columbia, United States
Baltimore, Maryland, United States
Detroit, Michigan, United States
Lake Success, New York, United States
Durham, North Carolina, United States
Cincinnati, Ohio, United States
Cleveland, Ohio, United States
Sylvania, Ohio, United States
West Reading, Pennsylvania, United States
Charleston, South Carolina, United States
Falls Church, Virginia, United States
Prairiewood, New South Wales, Australia
East Bentleigh, Victoria, Australia
Parkville, Victoria, Australia
Adelaide, , Australia
Budapest, , Hungary
Nyíregyháza, , Hungary
Székesfehérvár, , Hungary
Szikszó, , Hungary
Törökbálint, , Hungary
Beersheba, , Israel
Haifa, , Israel
Jerusalem, , Israel
Kfar Saba, , Israel
Petach Tikvah, , Israel
Tel Aviv, , Israel
Tel Litwinsky, , Israel
Ẕerifin, , Israel
Bydgoszcz, , Poland
Grudziądz, , Poland
Katowice, , Poland
Krakow, , Poland
Lodz, , Poland
Lublin, , Poland
Szczecin, , Poland
Warsaw, , Poland
Krasnodar, , Russia
Moscow, , Russia
Novosibirsk, , Russia
Saint Petersburg, , Russia
Yekaterinburg, , Russia
Leicester, , United Kingdom
Middlesex, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Laird BJA, Skipworth R, Bonomi PD, Fallon M, Kaasa S, Giorgino R, McMillan DC, Currow DC. Anamorelin Efficacy in Non-Small-Cell Lung Cancer Patients With Cachexia: Insights From ROMANA 1 and ROMANA 2. J Cachexia Sarcopenia Muscle. 2025 Feb;16(1):e13732. doi: 10.1002/jcsm.13732.
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.
Salsman JM, Beaumont JL, Wortman K, Yan Y, Friend J, Cella D. Brief versions of the FACIT-fatigue and FAACT subscales for patients with non-small cell lung cancer cachexia. Support Care Cancer. 2015 May;23(5):1355-64. doi: 10.1007/s00520-014-2484-9. Epub 2014 Oct 29.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
HT-ANAM-302
Identifier Type: -
Identifier Source: org_study_id