Clinical trial NCT01395914: Anamorelin HCl in the Treatment of Non-Small Cell Lung Cancer-Cachexia (NSCLC-C): An Extension Study (ROMANA 3)
Official title: Anamorelin HCl in the Treatment of Non-Small Cell Lung Cancer-Cachexia (NSCLC-C): An Extension Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Cachexia
Non-Small Cell Lung Cancer
Lead sponsor: Helsinn Therapeutics (U.S.), Inc
Sponsor class: INDUSTRY
First posted: 2011-07-18
Enrollment: 513
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: This is a randomized, double-blind, parallel-group, placebo-controlled, extension study to assess the safety and efficacy of Anamorelin HCl in NSCLC-C patients.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Percentage of Participants With Treatment-emergent Adverse Events
timeFrame: Over the 12-week treatment period
Secondary outcomes:
measure: Change in Body Weight
timeFrame: Change in body weight from baseline of the original trial through Week 12 of this extension trial.
measure: Change in Handgrip Strength of the Non-Dominant Hand
timeFrame: Change in HGS from baseline of the original trial through Week 12 of this extension trial.
measure: Change in A/CS Domain Score
timeFrame: Change in FAACT A/CS Domain Score from baseline of the original trial through Week 12 of this extension trial
Other outcomes:
Locations:
city: Corona
country: United States
state: California
city: Fountain Valley
country: United States
state: California
city: Fullerton
country: United States
state: California
city: Glendale
country: United States
state: California
city: La Jolla
country: United States
state: California
city: Riverside
country: United States
state: California
city: Washington, D.C.
country: United States
state: District of Columbia
city: Orange City
country: United States
state: Florida
city: Quincy
country: United States
state: Illinois
city: Indianapolis
country: United States
state: Indiana
city: Louisville
country: United States
state: Kentucky
city: Boston
country: United States
state: Massachusetts
city: Lake Success
country: United States
state: New York
city: Durham
country: United States
state: North Carolina
city: Cleveland
country: United States
state: Ohio
city: Sylvania
country: United States
state: Ohio
city: West Reading
country: United States
state: Pennsylvania
city: Charleston
country: United States
state: South Carolina
city: Falls Church
country: United States
state: Virginia
city: Prairiewood
country: Australia
state: New South Wales
city: Adelaide
country: Australia
city: East Bentleigh
country: Australia
city: Victoria
country: Australia
city: Brest
country: Belarus
city: Lesnoy
country: Belarus
city: Minsk
country: Belarus
city: Antwerpen
country: Belgium
city: Brussels
country: Belgium
city: Genk
country: Belgium
city: Gent
country: Belgium
city: Liege
country: Belgium
city: Edmonton
country: Canada
state: Alberta
city: Sault Ste Marie
country: Canada
state: Ontario
city: Toronto
country: Canada
state: Ontario
city: Montreal
country: Canada
state: Quebec
city: Benesov
country: Czechia
city: Brno
country: Czechia
city: Hlucin
country: Czechia
city: Liberec
country: Czechia
city: Nymburk
country: Czechia
city: Lyon Cedex
country: France
city: Villejuif cedex
country: France
city: Grosshansdorf
country: Germany
city: Halle
country: Germany
city: Budapest
country: Hungary
city: Kassai
country: Hungary
city: Beer-Sheva
country: Israel
city: Petach Tikvah
country: Israel
city: Tel-Hashomer
country: Israel
city: Zerifin
country: Israel
city: Piacenza
country: Italy
city: Bydgoszcz
country: Poland
city: Grudziadz
country: Poland
city: Katowice
country: Poland
city: Krakow
country: Poland
city: Lodz
country: Poland
city: Lublin
country: Poland
city: Szczecin
country: Poland
city: Warszawa
country: Poland
city: Ekaterinburg
country: Russian Federation
city: Krasnodar
country: Russian Federation
city: Moscow
country: Russian Federation
city: St. Petersburg
country: Russian Federation
city: Belgrade
country: Serbia
city: Sremska Kamenica
country: Serbia
city: Ljubljana
country: Slovenia
city: Barcelona
country: Spain
city: Sevilla
country: Spain
city: Valencia
country: Spain
city: Dnipropetrovsk
country: Ukraine
city: Kharkiv
country: Ukraine
city: Kyiv
country: Ukraine
Study officials:
References:
citation: 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.