Muscle cachexia due to non-small cell lung cancer (NSCLC). MedDRA version: 9.1 Level: LLT Classification code 10064015 Term: Cancer cachexia MedDRA version: 9.1 Level: LLT Classification code 10029521 Term: Non-small cell lung cancer stage IIIB MedDRA version: 9.1 Level: LLT Classification code 10029522 Term: Non-small cell lung cancer stage IV MedDRA version: 9.1 Level: LLT Classification code 10029515 Term: Non-small cell lung cancer recurrent
Conditions
Interventions
Product Name: AMG 745
Pharmaceutical Form: Solution for injection
Other descriptive name: AMG 745
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 30-
Sponsors
Amgen Inc
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Incurable Stage IIIb, IV, or recurrent NSCLC • Cachexia, defined as at least 5% weight loss within the previous 3 months due to NSCLC • Receiving or scheduled to receive a first-line platinum-based chemotherapy regimen every 3 weeks (Q3W) at the time of randomization. (Previous adjuvant chemotherapy is permitted) • Life expectancy of =6 months in the opinion of the investigator • ECOG performance status 0 or 1 • = 18 years old Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Incapacitation that interferes with ability to perform tests for study endpoints (such as severe or poorly controlled arthritis, or needing a walker / walking frame, or similar walking-aid device) • Active or impending spinal cord compression • Megace (megesterol) use within 21 days before randomization • Myopathies (except cancer cachexia), including steroid-induced myopathies • Current or history of known brain metastases • Major surgery in past 3 months • ALT and/or AST > 2.5 x ULN (local laboratory) • Serum creatinine > 2 x ULN (local laboratory) • Hemoglobin (Hgb) 5 mg prednisone daily equivalent (Intermittent corticosteroid use associated with anti-neoplastic therapy and inhaled corticosteroids for respiratory conditions or symptoms are permitted.) • Current anabolic steroid therapy or growth hormone (subjects can receive physiologic doses of testosterone if they are hypogonadal. Dose must be stable for 3 months before screening, and not expected to change dose during study.) • Planned surgeries requiring > 24 hr hospitalization while in the study treatment period • Current mechanical obstruction of GI tract • Current uncontrolled nausea or vomiting, or diarrhea • Known HIV infection • Subject of child-bearing potential is evidently pregnant (eg, positive HCG test) or is breast feeding. • Current unstable or uncontrolled disease (other than cancer) or condition related to or impacting cardiac function (eg, unstable angina, congestive heart failure [New York Heart Association = class III]) • Clinically significant psychiatric or neurologic disorder • Subject has any kind of disorder that compromises the ability of the subject to give written informed consent and/or to comply with study procedures • Subject currently is enrolled in or has not yet completed at least 30 days since ending other investigational device or drug study(s), or subject is receiving other investigational agent(s).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the effect of AMG 745 on strength in subjects with cachexia due to NSCLC and to evaluate the safety and tolerability profile of AMG 745 in this patient population. ;Secondary Objective: To evaluate the effect of AMG 745 on physical function, muscle size, weight, and survival.;Primary end point(s): Change from baseline to week 6 in dominant hand grip strength | — |
Countries
Germany, Sweden
Outcome results
None listed