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: 14.0Level: LLTClassification code 10002646Term: AnorexiaSystem Organ Class: 10027433 - Metabolism and nutrition disorders; MedDRA version: 14.0Level: LLTClassification code 10064015Term: Cancer cachexiaSystem Organ Class: 10027433 - Metabolism and nutrition disorders; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2010-023650-36-ES
• Lead Sponsor: Helsinn Therapeutics (U.S.), Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-06-28
• Last Update Posted: 24 November 2014

Recruitment & Eligibility

• Status: ot Recruiting
• 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:
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