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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
- Primary Objectives
- To evaluate the effect of Anamorelin HCl on LBM as measured by DXA
- To evaluate the effect of Anamorelin HCl on muscle strength as measured by HGS
- Secondary Objectives
- To evaluate the effect of Anamorelin HCl on body weight
- To evaluate the effect of Anamorelin HCl on quality of life as assessed using the FACIT-F (Functional Assessment of Chronic Illness Therapy – Fatigue) and the FAACT (Functional Assessment of Anorexia/Cachexia Treatment) (see Appendix III)
- To evaluate the effect of Anamorelin HCl on overall survival
- Exploratory Objective
- To evaluate the effect of Anamorelin HCl on quality of life as assessed using the Hunger Assessment Scale (see Appendix IV)
- Safety Objectives
- To evaluate the safety and tolerability of Anamorelin HCl
- Females and males at least 18 years of age
- Documented histologic or cytologic diagnosis of American Joint Committee on Cancer (AJCC) Stage III or IV NSCLC. Stage III patients must have unresectable disease.
- With regard to chemotherapy and/or radiation therapy:
- 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. Weights may have been measured or obtained and documented by patient history.
- Body mass index ≤30 kg/m²
- ECOG performance status ≤2 (see Appendix I)
- Estimated life expectancy of >4 months at the time of screening
- Adequate hepatic function, defined as AST and ALT levels ≤5 x ULN
- Adequate renal function, defined as creatinine ≤2 x ULN, or calculated creatinine clearance >30 ml/minute
- The patient is able to understand and comply with the procedures for the HGS evaluation.
- If the patient is 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).
- The patient 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.
- Other forms of lung cancer (e.g., small cell, mesothelioma)
- Women who are pregnant or breast-feeding
- Known HIV, hepatitis (B and 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
- Patients unable 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
- Patients receiving strong CYP3A4 inhibitors within 14 days of randomization (see Appendix VI)
- Patients 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
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