Author of

• 12853

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  P3.24 - Poster Session 3 - Supportive Care (ID 160)

  • Event: WCLC 2013
  • Type: Poster Session
  • Track: Supportive Care
  • Presentations: 1
  • Moderators:
  • Coordinates: 10/30/2013, 09:30 - 16:30, Exhibit Hall, Ground Level

  • 12884

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    P3.24-031 - Anamorelin HCl for the Treatment of Anorexia-Cachexia in NSCLC: Baseline Characteristics of Patients in the Phase III Clinical Trial ROMANA 2 (HT-ANAM-302) (ID 1936)

    09:30 - 09:30  |  Author(s): J. Temel
    • Abstract

    Methods
    HT-ANAM-301 (NCT01387269) and HT-ANAM-302 (NCT01387282), also known as ROMANA 1 and ROMANA 2, are double-blind, placebo-controlled, randomized (2:1 anamorelin HCl vs. placebo) Phase III trials in patients with NSCLC cachexia, with a target enrollment of 477 patients per study. Eligible patients must have unresectable Stage III or IV NSCLC and cachexia (weight loss of ≥5% body weight within prior 6 months or BMI <20 kg/m[2]). Patients receive once daily oral doses of anamorelin HCl (100 mg) or placebo for 12 weeks. Co-primary endpoints are the change from baseline in LBM as measured by DXA scan and in muscle strength as measured by handgrip strength (HGS). Secondary endpoints include change in body weight, overall survival, and quality of life. For HT-ANAM-301 only, blood samples are collected at Week 6 for population pharmacokinetics. After 12 weeks of treatment, patients may continue in a separate 12-week safety extension study (HT-ANAM-303 [ROMANA 3] NCT01395914).

    Results
    As of June 2013, 448 patients (93.9%) have been enrolled in ROMANA 2, and key baseline characteristics based on preliminary data available to-date are presented in the Table.Figure 1