Anamorelin HCl in the Treatment of Non-Small Cell Lung Cancer-Cachexia (NSCLC-C): An Extension Study (ROMANA 3)
1 other identifier
interventional
513
16 countries
69
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jul 2011
Typical duration for phase_3
69 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 30, 2011
CompletedStudy Start
First participant enrolled
July 1, 2011
CompletedFirst Posted
Study publicly available on registry
July 18, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2015
CompletedResults Posted
Study results publicly available
July 11, 2017
CompletedSeptember 14, 2017
August 1, 2017
2.9 years
June 30, 2011
March 15, 2017
August 16, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Percentage of Participants With Treatment-emergent Adverse Events
To Evaluate the Safety and Tolerability of Anamorelin HCl.
Over the 12-week treatment period
Secondary Outcomes (3)
Change in Body Weight
Change in body weight from baseline of the original trial through Week 12 of this extension trial.
Change in Handgrip Strength of the Non-Dominant Hand
Change in HGS from baseline of the original trial through Week 12 of this extension trial.
Change in A/CS Domain Score
Change in FAACT A/CS Domain Score from baseline of the original trial through Week 12 of this extension trial
Study Arms (2)
100 mg QD
EXPERIMENTAL100 mg yellow coated, oval tablet; oral administration once daily
Placebo
PLACEBO COMPARATORPlacebo tablets identical in appearance to active tablets; oral administration once daily
Interventions
Eligibility Criteria
You may qualify if:
- Has completed the Day 85 Visit in the original trial (Study HT-ANAM-301 or HT-ANAM-302) and is considered appropriate to continue to receive additional study drug; must start dosing on the extension study within 5 days of completing dosing on the original trial
- 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
You may not qualify if:
- Women who are pregnant or breast-feeding
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (72)
Unknown Facility
Corona, California, United States
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Fountain Valley, California, United States
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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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Washington D.C., District of Columbia, United States
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Orange City, Florida, United States
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Quincy, Illinois, United States
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Indianapolis, Indiana, United States
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Louisville, Kentucky, United States
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Boston, Massachusetts, United States
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Lake Success, New York, United States
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Durham, North Carolina, United States
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Cleveland, Ohio, United States
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Sylvania, Ohio, United States
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West Reading, Pennsylvania, United States
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Charleston, South Carolina, United States
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Falls Church, Virginia, United States
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Prairiewood, New South Wales, Australia
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Adelaide, Australia
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East Bentleigh, Australia
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Victoria, Australia
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Brest, Belarus
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Lesnoy, Belarus
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Minsk, Belarus
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Antwerp, Belgium
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Brussels, Belgium
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Genk, Belgium
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Ghent, Belgium
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Liège, Belgium
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Edmonton, Alberta, Canada
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Sault Ste. Marie, Ontario, Canada
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Toronto, Ontario, Canada
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Montreal, Quebec, Canada
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Benešov, Czechia
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Brno, Czechia
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Hlučín, Czechia
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Liberec, Czechia
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Nymburk, Czechia
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Lyon, France
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Villejuif, France
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Großhansdorf, Germany
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Halle, Germany
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Budapest, Hungary
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Kassai, Hungary
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Beersheba, Israel
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Petach Tikvah, Israel
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Tel Litwinsky, Israel
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Ẕerifin, Israel
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Piacenza, Italy
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Bydgoszcz, Poland
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Grudziądz, Poland
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Katowice, Poland
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Krakow, Poland
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Lodz, Poland
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Lublin, Poland
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Szczecin, Poland
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Warsaw, Poland
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Krasnodar, Russia
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Moscow, Russia
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Saint Petersburg, Russia
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Yekaterinburg, Russia
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Belgrade, Serbia
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Kamenitz, Serbia
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Ljubljana, Slovenia
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Barcelona, Spain
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Seville, Spain
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Valencia, Spain
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Dnipropetrovsk, Ukraine
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Kharkiv, Ukraine
Unknown Facility
Kyiv, Ukraine
Related Publications (1)
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.
PMID: 28472437DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Richard K. Bourne, Ph.D.
- Organization
- Helsinn Therapeutics (US), Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 30, 2011
First Posted
July 18, 2011
Study Start
July 1, 2011
Primary Completion
June 1, 2014
Study Completion
February 1, 2015
Last Updated
September 14, 2017
Results First Posted
July 11, 2017
Record last verified: 2017-08