E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Muscle cachexia due to non-small cell lung cancer (NSCLC). |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10064015 |
E.1.2 | Term | Cancer cachexia |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10029521 |
E.1.2 | Term | Non-small cell lung cancer stage IIIB |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10029522 |
E.1.2 | Term | Non-small cell lung cancer stage IV |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10029515 |
E.1.2 | Term | Non-small cell lung cancer recurrent |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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. |
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E.2.2 | Secondary objectives of the trial |
To evaluate the effect of AMG 745 on physical function, muscle size, weight, and survival. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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
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E.4 | Principal 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) < 9 g/dL • Current chronic systemic corticosteroid use > 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).
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E.5 End points |
E.5.1 | Primary end point(s) |
Change from baseline to week 6 in dominant hand grip strength |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | Yes |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | Yes |
E.6.13 | Others | Information not present in EudraCT |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 28 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | 16 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial months | 16 |