Clinical trial NCT01387282: Safety and Efficacy of Anamorelin HCl in Patients With Non-Small Cell Lung Cancer-Cachexia (ROMANA 2)
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: 495
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.

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: Corona
country: United States
state: California
city: Fountain Valley
country: United States
state: California
city: Glendale
country: United States
state: California
city: Washington, D.C.
country: United States
state: District of Columbia
city: Baltimore
country: United States
state: Maryland
city: Detroit
country: United States
state: Michigan
city: Lake Success
country: United States
state: New York
city: Durham
country: United States
state: North Carolina
city: Cincinnati
country: United States
state: Ohio
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: East Bentleigh
country: Australia
state: Victoria
city: Parkville
country: Australia
state: Victoria
city: Adelaide
country: Australia
city: Budapest
country: Hungary
city: Nyiregyhaza
country: Hungary
city: Szekesfehervar
country: Hungary
city: Szikszo
country: Hungary
city: Torokbalint
country: Hungary
city: Beer-Sheva
country: Israel
city: Haifa
country: Israel
city: Jerusalem
country: Israel
city: Kfar Saba
country: Israel
city: Petach Tikvah
country: Israel
city: Tel Aviv
country: Israel
city: Tel-Hashomer
country: Israel
city: Zerifin
country: Israel
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: Novosibirsk
country: Russian Federation
city: Saint Petersburg
country: Russian Federation
city: St. Petersburg
country: Russian Federation
city: Leicester
country: United Kingdom
city: Middlesex
country: United Kingdom
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.
citation: Salsman JM, Beaumont JL, Wortman K, Yan Y, Friend J, Cella D. Brief versions of the FACIT-fatigue and FAACT subscales for patients with non-small cell lung cancer cachexia. Support Care Cancer. 2015 May;23(5):1355-64. doi: 10.1007/s00520-014-2484-9. Epub 2014 Oct 29.