Anamorelin HCl in the Treatment of Non-Small Cell Lung Cancer-Cachexia (NSCLC-C): An Extension Study (ROMANA 3)
NCT ID: NCT01395914
Last Updated: 2017-09-14
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
513 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
100 mg yellow coated, oval tablet; oral administration once daily
Anamorelin HCl
Placebo
Placebo tablets identical in appearance to active tablets; oral administration once daily
Placebo
Interventions
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Anamorelin HCl
Placebo
Eligibility Criteria
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Inclusion Criteria
* ECOG performance status ≤2
* Life expectancy of \>4 months at time of screening
* If 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
* Had major surgery (central venous access placement and tumor biopsies are not considered major surgery) within 4 weeks prior to enrollment into the extension study; 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 known or symptomatic brain metastases
* Receiving strong CYP3A4 inhibitors
* 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
* Patients actively receiving a concurrent investigational agent, other than Anamorelin HCl
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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Corona, California, United States
Fountain Valley, California, United States
Fullerton, California, United States
Glendale, California, United States
La Jolla, California, United States
Riverside, California, United States
Washington D.C., District of Columbia, United States
Orange City, Florida, United States
Quincy, Illinois, United States
Indianapolis, Indiana, United States
Louisville, Kentucky, United States
Boston, Massachusetts, United States
Lake Success, New York, United States
Durham, North Carolina, 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
Adelaide, , Australia
East Bentleigh, , Australia
Victoria, , Australia
Brest, , Belarus
Lesnoy, , Belarus
Minsk, , Belarus
Antwerp, , Belgium
Brussels, , Belgium
Genk, , Belgium
Ghent, , 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
Großhansdorf, , Germany
Halle, , Germany
Budapest, , Hungary
Kassai, , Hungary
Beersheba, , Israel
Petach Tikvah, , Israel
Tel Litwinsky, , Israel
Ẕerifin, , Israel
Piacenza, , Italy
Bydgoszcz, , Poland
Grudziądz, , Poland
Katowice, , Poland
Krakow, , Poland
Lodz, , Poland
Lublin, , Poland
Szczecin, , Poland
Warsaw, , Poland
Krasnodar, , Russia
Moscow, , Russia
Saint Petersburg, , Russia
Yekaterinburg, , Russia
Belgrade, , Serbia
Kamenitz, , Serbia
Ljubljana, , Slovenia
Barcelona, , Spain
Seville, , Spain
Valencia, , Spain
Dnipropetrovsk, , Ukraine
Kharkiv, , Ukraine
Kyiv, , Ukraine
Countries
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References
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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.
Other Identifiers
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HT-ANAM-303
Identifier Type: -
Identifier Source: org_study_id
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