A clinical trial studying the safety and effectiveness of the study drug Anamorelin HCl for treating cachexia (weight loss and muscle mass loss) in patients with Non-Small Cell Lung Cancer

Conditions: on-Small Cell Lung Cancer related Cachexia (NSCLC-C)
MedDRA version: 14.1Level: SOCClassification code 10027433Term: Metabolism and nutrition disordersSystem Organ Class: 10027433 - Metabolism and nutrition disorders
Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

Registration Number: EUCTR2010-023648-34-IT

Lead Sponsor: HELSINN THERAPEUTICS (U.S), INC

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 477

Inclusion Criteria

• 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: o Patients may be receiving maintenance chemotherapy after receiving first line chemotherapy. o Patients may be initiating a new chemotherapy (first or second line) and/or radiation therapy regimen at the time of randomization, but may not have started the regimen greater than 7 days before randomization. o 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 BMI <20 kg/m2. Weights may have been measured or obtained and documented by patient history. • Body mass index less than/equal 30 kg/m2 • ECOG performance status less than/equal 2 (see Appendix I) • Estimated life expectancy of >4 months at the time of screening • Adequate hepatic function, defined as aspartate aminotransferase (AST) and alanine aminotransferase (ALT) levels less than/equal 5 ? upper limit of normal (ULN) • Adequate renal function, defined as creatinine less than/equal 2 ? ULN, or calculated creatinine clearance more than 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.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
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

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 • Patients who have completed 2 or more prior cytotoxic chemotherapy regimens • 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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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