This trial is active, not recruiting.

Conditions cachexia, non-small cell lung cancer
Treatments anamorelin hcl, placebo
Phase phase 3
Sponsor Helsinn Therapeutics (U.S.), Inc
Start date July 2011
End date June 2014
Trial size 300 participants
Trial identifier NCT01395914, HT-ANAM-303


The administration of Anamorelin HCl in patients with Non-Small Cell Lung Cancer-Cachexia (NSCLC-C) is expected to increase appetite, lean body mass, weight gain, and muscle strength.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
100 mg yellow coated, oval tablet; oral administration once daily
anamorelin hcl
(Placebo Comparator)
Placebo tablets identical in appearance to active tablets; oral administration once daily

Primary Outcomes

Evaluate the safety and tolerability of Anamorelin
time frame: 12 weeks

Secondary Outcomes

Evaluate the effect of Anamorelin on body weight
time frame: 12 weeks
Evaluate the effect of Anamorelin on muscle strength as measured by hand-grip strength (HGS)
time frame: 12 weeks
Evaluate the effect of Anamorelin HCl on quality of life as assessed using the FACIT-F (Functional Assessment of Chronic Illness Therapy-Fatigue) and the FAACT (Functional Assessment of Anorexia/Cachexia Treatment)
time frame: 12 weeks

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Has completed the Day 85 Visit in the original trial (Study HT-ANAM-301 or HT-ANAM-302) and is considered appropriate to continue to receive additional study drug; must start dosing on the extension study within 5 days of completing dosing on the original trial - ECOG performance status ≤2 - Life expectancy of >4 months at time of screening - If 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) - 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 Exclusion Criteria: - 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 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 - 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 - Inability 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 known or symptomatic brain metastases - Receiving strong CYP3A4 inhibitors - 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 - Patients actively receiving a concurrent investigational agent, other than Anamorelin HCl

Additional Information

Official title Anamorelin HCl in the Treatment of Non-Small Cell Lung Cancer-Cachexia (NSCLC-C): An Extension Study
Description This is a randomized, double-blind, parallel-group, placebo-controlled, extension study to assess the safety and efficacy of Anamorelin HCl in NSCLC-C patients.
Trial information was received from ClinicalTrials.gov and was last updated in July 2014.
Information provided to ClinicalTrials.gov by Helsinn Therapeutics (U.S.), Inc.