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 January 2014
Trial size 477 participants
Trial identifier NCT01387269, HT-ANAM-301


The administration of Anamorelin in patients with Stage III-IV 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
anamorelin hcl
Randomization of 2:1
(Placebo Comparator)
Placebo tablets identical in appearance to active tablets; oral administration once daily

Primary Outcomes

Evaluate the effect of Anamorelin on lean body mass as measured by DXA scan
time frame: 12 weeks
Evaluate the effect of Anamorelin on muscle strength as measured by hand-grip strength
time frame: 12 weeks

Secondary Outcomes

To evaluate the effect of Anamorelin HCl on body weight
time frame: 12 weeks
To evaluate the effect of Anamorelin HCl on quality of life as assessed by using the FACIT-F (Functional Assessment of Chronic Illness Therapy-Fatigue) and the FAACT (Functional Assessment of Anorexia/Cachexia Treatment)
time frame: 12 weeks
To evaluate the effect of Anamorelin HCl on overall survival
time frame: 12 weeks

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Documented diagnosis of unresectable Stage III or Stage IV NSCLC - 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 ≥5% body weight within 6 months prior to screening or a screening body mass index (BMI) <20 kg/m2 - Body mass index ≤30 kg/m2 - Life expectancy of >4 months at time of screening - ECOG performance status ≤2 - Adequate hepatic function, defined as AST and ALT levels ≤5 x upper limit of normal - Adequate renal function, defined as creatinine ≤2 x upper limit of normal, or calculated creatinine clearance >30 ml/minute - Ability to understand and comply with the procedures for the HGS evaluation - If 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) - 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: - 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 - 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 - 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 uncontrolled diabetes mellitus - Has untreated clinically relevant hypothyroidism - Has known or symptomatic brain metastases - Receiving strong CYP3A4 inhibitors within 14 days of randomization - 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

Additional Information

Official title Anamorelin HCl in the Treatment of Non-Small Cell Lung Cancer-Cachexia (NSCLC-C): A Randomized Double-Blind Placebo-Controlled Multicenter Phase III Study to Evaluate the Safety and Efficacy of Anamorelin HCl in Patients With NSCLC-C
Description This is a randomized, double-blind, placebo-controlled, multicenter study to assess the safety and efficacy of Anamorelin in patients with non-small cell lung cancer-cachexia (NSCLC-C). The primary efficacy analysis will include the treatment difference in the change in lean body mass and physical function. Pharmacokinetic (PK) samples will also be collected at Day 43 visit for population PK.
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.