A clinical trial studying the safety and effectiveness of the study drugAnamorelin 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] - Cancer [C04]

Registration Number: EUCTR2010-023650-36-IT

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

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 350

Inclusion Criteria

The patient has completed the Day 85 Visit in the original trial (Study HT ANAM-301 or HT-ANAM-302) and the Investigator considers the patient to be appropriate to continue to receive an additional 12 weeks of study drug administration. The patient must start dosing on the extension study within 5 days of completing dosing on the original trial. • Females and males at least 18 years of age • ECOG performance status less than / equal to 2
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 234
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 116

Exclusion Criteria

Women who are pregnant or breast-feeding • Patients who have received 2 prior regimens of cytotoxic chemotherapy and are undergoing, or planning to undergo, a third regimen of cytotoxic chemotherapy • Patients must not be planning to initiate a new chemotherapy and/or radiation therapy regimen in the middle of the 12-week treatment period at the time of enrollment into this extension study. • 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. • Patients unable to readily swallow oral tablets. Patients with severe gastointestinal disease (including esophagitis, gastritis, malaborption, or obstructive symptoms) or intractable or frequent vomiting are excluded. • Has known or symptomatic brain metastases

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the safety and tolerability of Anamorelin HCl;Secondary Objective: 1. To evaluate the effect of Anamorelin HCl on body weight 2. To evaluate the effect of Anamorelin HCl on muscle strength as measured by hand grip strength 3. To evaluate the effect of Anamorelin HCl on quality of life as assessed using the FAACT (Functional Assessment of Anorexia/Cachexia Treatment) and the FACIT F (Functional Assessment of Chronic Illness Therapy – Fatigue) (see Appendix II);Primary end point(s): 1. Changes in body weight from baseline of the HT-ANAM-301 or HTANAM- 302 trials 2. Change in Hand Grip Strength of the non-dominant hand 3. Change in HGS of the dominant hand 4. Quality of life;Timepoint(s) of evaluation of this end point: 1. Changes in body weight at Weeks 4, 8, 12 2. Changes in Hand Grip Strength of non-dominant hand at Weeks 8, 12 3. Changes in Hand Grip Strength of dominant hand at Weeks 8, 12 4. Quality of life as assessed by FAACT and FACIT-F at Weeks 4, 8, 12

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): NA;Timepoint(s) of evaluation of this end point: NA

Related Trials