Safety and Efficacy of Anamorelin HCl in Patients With Non-Small Cell Lung Cancer-Cachexia (ROMANA 1)
Condition: Cachexia; Non-Small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Wasting Syndrome; Cachexia
Intervention: Anamorelin HCl; Placebo
Intervention description: Anamorelin HCl will be orally administered daily at least one hour before meal; Placebo tablets identical in appearance to active tablets; oral administration QD for 12 weeks, at least 1 hour before meal
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 484.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

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.
    

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