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

Helsinn Therapeutics (U.S.), Inc.0 个研究点目标入组 477 人开始时间: 2011年8月29日最近更新: 2014年11月3日

研究概览

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•Females and males at least 18 years of age
•Documented histologic or cytologic diagnosis of 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 (after first line chemotherapy), Patients may be initiating a new chemotherapy (first or second line) and/or radiation therapy regimen within 7 days of study drug randomization, patients are receiving no chemotherapy and/or radiation for NSCLC
•Involuntary weight loss of greater than/equal to 5% body weight within 6 months prior to screening or a screening BMI <20 kg/m2.
•Body mass index less than/equal to 30 kg/m2
•ECOG less than/equal to 2
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 317
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 160

•Other forms of lung cancer (eg, small cell, mesothelioma)
•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 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.
•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 untreated clinically relevant hypothyroidism
•Has known or symptomatic brain metastases

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