Safety and Efficacy of Anamorelin HCl in Patients With Non-Small Cell Lung Cancer-Cachexia (ROMANA 1)
NCT ID: NCT01387269
Last Updated: 2017-10-27
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
484 participants
INTERVENTIONAL
2011-07-31
2015-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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100 mg QD
Anamorelin HCL 100 mg will be administered daily
Anamorelin HCl
Anamorelin HCl will be orally administered daily at least one hour before 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 before meal
Interventions
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Anamorelin HCl
Anamorelin HCl will be orally administered daily at least one hour before meal
Placebo
Placebo tablets identical in appearance to active tablets; oral administration QD for 12 weeks, at least 1 hour before meal
Eligibility Criteria
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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
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Helsinn Therapeutics (U.S.), Inc
INDUSTRY
Responsible Party
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Locations
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Fullerton, California, United States
Glendale, California, United States
La Jolla, California, United States
Riverside, California, United States
Orange City, Florida, United States
Quincy, Illinois, United States
Indianapolis, Indiana, United States
Louisville, Kentucky, United States
Boston, Massachusetts, United States
Northport, New York, United States
Cincinnati, Ohio, United States
Houston, Texas, United States
Brest, , Belarus
Lesnoy, , Belarus
Minsk, , Belarus
Antwerp, , Belgium
Brussels, , Belgium
Genk, , Belgium
Liège, , Belgium
Edmonton, Alberta, Canada
Sault Ste. Marie, Ontario, Canada
Toronto, Ontario, Canada
Montreal, Quebec, Canada
Benešov, , Czechia
Brno, , Czechia
Hlučín, , Czechia
Liberec, , Czechia
Nymburk, , Czechia
Lyon, , France
Villejuif, , France
Berlin, , Germany
Großhansdorf, , Germany
Halle, , Germany
Minden, , Germany
Budapest, , Hungary
Placenza, , Italy
Rozzano, , Italy
Amsterdam, , Netherlands
Goes, , Netherlands
Maastricht, , Netherlands
Nieuwegein, , Netherlands
Grudziądz, , Poland
Katowice, , Poland
Krakow, , Poland
Lublin, , Poland
Saint Petersburg, , Russia
Yekaterinburg, , Russia
Belgrade, , Serbia
Kamenitz, , Serbia
Golnik, , Slovenia
Ljubljana, , Slovenia
Barcelona, , Spain
Córdoba, , Spain
Seville, , Spain
Valencia, , Spain
Dnipropetrovsk, , Ukraine
Donetsk, , Ukraine
Kharkiv, , Ukraine
Kyiv, , Ukraine
Zaporizhzhya, , Ukraine
Countries
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References
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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.
Other Identifiers
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HT-ANAM-301
Identifier Type: -
Identifier Source: org_study_id