Clinical trial NCT01387269: Safety and Efficacy of Anamorelin HCl in Patients With Non-Small Cell Lung Cancer-Cachexia (ROMANA 1)
Official title: Anamorelin HCl in the Treatment of Non-Small Cell Lung Cancer-Cachexia (NSCLC-C): A Randomized Double-Blind Placebo-Controlled Multicenter Phase III Study to Evaluate the Safety and Efficacy of Anamorelin HCl in Patients With NSCLC-C
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: 2011-07-04
Enrollment: 484
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 in patients with Stage III-IV 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, placebo-controlled, multicenter study to assess the safety and efficacy of Anamorelin in patients with non-small cell lung cancer-cachexia (NSCLC-C). The primary efficacy analysis will include the treatment difference in the change in lean body mass and physical function. Pharmacokinetic (PK) samples will also be collected at Day 43 visit for population PK.

Eligibility criteria: Inclusion Criteria:

* Documented diagnosis of unresectable Stage III or Stage IV NSCLC
* 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:

* Other forms of lung cancer (e.g., small cell, mesothelioma)
* 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

Primary outcomes:
measure: Change in Lean Body Mass
timeFrame: Change in Lean Body Mass from Baseline Over 12 Weeks
measure: Change in Handgrip Strength
timeFrame: Change in Handgrip Strength of the Non-Dominant Hand from Baseline Over 12 Weeks
Secondary outcomes:
measure: Change in A/CS Domain Score
timeFrame: Change in FAACT A/CS Domain Score from Baseline Over 12 Weeks
measure: Change in FACIT-F Fatigue Domain Score
timeFrame: Change in FACIT-F Fatigue Domain Score from Baseline Over 12 Weeks
measure: Change in Body Weight
timeFrame: Change in Body Weight from Baseline Over 12 Weeks
Other outcomes:
Locations:
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: 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: Northport
country: United States
state: New York
city: Cincinnati
country: United States
state: Ohio
city: Houston
country: United States
state: Texas
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: 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: Berlin
country: Germany
city: Grosshansdorf
country: Germany
city: Halle
country: Germany
city: Minden
country: Germany
city: Budapest
country: Hungary
city: Placenza
country: Italy
city: Rozzano
country: Italy
city: Amsterdam
country: Netherlands
city: Goes
country: Netherlands
city: Maastricht
country: Netherlands
city: Nieuwegein
country: Netherlands
city: Grudziadz
country: Poland
city: Katowice
country: Poland
city: Krakow
country: Poland
city: Lublin
country: Poland
city: Ekaterinburg
country: Russian Federation
city: St. Petersburg
country: Russian Federation
city: Belgrade
country: Serbia
city: Sremska Kamenica
country: Serbia
city: Golnik
country: Slovenia
city: Ljubljana
country: Slovenia
city: Barcelona
country: Spain
city: Cordoba
country: Spain
city: Sevilla
country: Spain
city: Valencia
country: Spain
city: Dnipropetrovsk
country: Ukraine
city: Donetsk
country: Ukraine
city: Kharkiv
country: Ukraine
city: Kyiv
country: Ukraine
city: Zaporizhzhya
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.
citation: 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.