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: 15.1Level: LLTClassification code 10064015Term: Cancer cachexiaSystem Organ Class: 100000004861; MedDRA version: 15.1Level: LLTClassification code 10002646Term: AnorexiaSystem Organ Class: 100000004861; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2010-023648-34-PL
• Lead Sponsor: Helsinn Therapeutics (U.S.), Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-11-30
• Last Update Posted: 3 November 2014

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: 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 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
Estimated life expectancy of >4 months at the time
of screening
•Adequate hepatic function, defined as aspartate
aminotransferase (AST) and alanine
aminotransferase (ALT) levels =5 xupper limit of
normal (ULN)
•Adequate renal function, defined as creatinine
=2 xULN, or calculated creatinine clearance
>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:
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 (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.
•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