Anamorelin HCl in the Treatment of Non-Small Cell Lung Cancer-Cachexia (NSCLC-C): An Extension Study (ROMANA 3)
Condition: Cachexia; Non-Small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Wasting Syndrome; Cachexia
Intervention: Anamorelin HCl; Placebo
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 513.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The administration of Anamorelin HCl in patients with 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:

          -  Has completed the Day 85 Visit in the original trial (Study HT-ANAM-301 or
             HT-ANAM-302) and is considered appropriate to continue to receive additional study
             drug; must start dosing on the extension study within 5 days of completing dosing on
             the original trial

          -  ECOG performance status ≤2

          -  Life expectancy of >4 months at time of screening

          -  If 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:

          -  Women who are pregnant or breast-feeding

          -  Had major surgery (central venous access placement and tumor biopsies are not
             considered major surgery) within 4 weeks prior to enrollment into the extension study;
             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 known or symptomatic brain metastases

          -  Receiving strong CYP3A4 inhibitors

          -  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

          -  Patients actively receiving a concurrent investigational agent, other than Anamorelin
             HCl