A Study to Evaluate the Efficacy and Safety of Anamorelin HCl for the Treatment of Malignancy Associated Weight Loss and Anorexia in Adult Patients With Advanced Non-Small Cell Lung Cancer (NSCLC)

Completed · Phase 3 · Has a placebo group

Conditions studied: Cachexia; Cancer, Non Small Cell Lung Cancer

In brief

The goal of this clinical trial was to compare the efficacy and safety of anamorelin HCl (the investigational drug) to that of placebo (tablet with no drug) in patients with advanced non-small cell lung cancer and cachexia (cancer-related weight loss). The main question it aimed to answer was as follows: Do patients who receive anamorelin HCl gain more body weight and show more improvement in anorexia symptoms than those who receive placebo. Approximately 316 patients were to be enrolled in the study. Of these patients, an equal number were to be assigned to each treatment group (anamorelin HCl or placebo). Participants were to take their assigned study drug by mouth once daily for a total of 24 weeks. During this treatment period, the patients were to visit the clinical study site every 3 weeks for health and other study-related assessments. Two weeks after the last treatment, patients were to receive a follow-up phone call.

Key facts

Study ID

NCT03743064

Run by

Helsinn Healthcare SA

People needed

318

Starts

2019-05-06

Expected to finish

2022-12-27

Last updated by the study team

2024-06-26

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Signed written informed consent
• Female or male ≥18 years of age
• Documented histologic or cytologic diagnosis of American Joint Committee on Cancer (AJCC) Stage III or IV NSCLC. Stage III patient must have unresectable disease
• Body mass index < 20 kg/m2 with involuntary weight loss of >2% within 6 months prior to screening
• Ongoing problems with appetite/eating associated with the underlying cancer, as determined by having score of ≤ 17 points on the 5-item Anorexia Symptom Scale and ≤ 37 points on the 12-item FAACT A/CS
• Patient receiving or not receiving systemic anti-cancer treatment at the time of screening are eligible to participate. Systemic anti-cancer treatment includes first, second, third treatment line with chemotherapy/radiation therapy, immunotherapy or targeted therapy.
• Patient not receiving systemic anti-cancer treatment is eligible if:
• Not planning to receive anti-cancer treatment and/or at least 14 days must be elapsed from the completion of prior treatment at the day of screening, in case underwent previous cycle OR
• Planning to receive anti-cancer treatment within 14 days from randomization and/or at least 14 days must be elapsed from the completion of prior treatment at the day of screening, in case underwent previous cycle OR
• Patient on palliative care treatment
• ECOG performance status 0,1 or 2 at screening
• AST (SGOT) and ALT (SGPT) ≤ 3 x ULN or if hepatic metastases are present ≤ 5 x ULN
• Adequate renal function, defined as creatinine ≤2 ULN, or calculated creatinine clearance >30 ml/minute
• Female patient shall be: a) of non-childbearing potential or b) of childbearing potential using reliable contraceptive measures and having a negative urine pregnancy test within 24 hours prior to first dose of investigational product.
• Notes:
• Female patient of non-childbearing potential are defined as being in post-menopausal state since at least 1 year; or having documented surgical sterilization or hysterectomy at least 3 months before study participation.
• Reliable contraceptive measures include implants, injectables, combined oral contraceptives, intrauterine devices, vasectomized partner or complete (long term) sexual abstinence.
• The patient must be willing and able to comply with the protocol tests and procedures All inclusion criteria will be checked at screening visit (Visit 1).

You may not qualify if…

• Patient with other forms of lung cancer (e.g., small cell, neuroendocrine tumors)
• Woman who is pregnant or breast-feeding
• Reversible causes of reduced food intake, as determined by the Investigator. These causes may include but are not limited to:
• NCI CTCAE Grade 3 or 4 oral mucositis,
• NCI CTCAE Grade 3 or 4 GI disorders [nausea, vomiting, diarrhea, and constipation],
• mechanical obstructions making patient unable to eat, or
• severe depression
• Patient undergoing major surgery (central venous access placement and tumor biopsies are not considered major surgery) within 4 weeks prior to randomization. Patient must be well recovered from acute effects of surgery prior to screening. Patient should not have plans to undergo major surgical procedures during the treatment period
• Patient currently taking androgenic compounds (including but not limited to testosterone, testosterone-like agents, oxandrolone, megestrol acetate, corticosteroids, olanzapine, mirtazapine (however, long-term use of mirtazapine for depression for at least four weeks prior to screening is allowed), dronabinol or marijuana (cannabis) or any other prescription medication or off-label products intended to increase appetite or treat unintentional weight loss
• Patient with pleural effusion requiring thoracentesis, pericardial effusion requiring drainage, edema or evidence of ascites
• Patient with uncontrolled or significant cardiovascular disease, including:
• History of myocardial infarction within the past 3 months
• A-V block of second or third degree (may be eligible if currently have a pacemaker)
• Unstable angina
• Congestive heart failure within the past 3 months, if defined as NYHA class III-IV
• Any history of clinically significant ventricular arrhythmias (such as ventricular tachycardia, ventricular fibrillation, Wolff-Parkinson-White (WPW) syndrome, or torsade de pointes)
• Uncontrolled hypertension (blood pressure >150 mm Hg systolic and >95 mm Hg diastolic)
• Heart rate < 50 beats per minute on pre-entry electrocardiogram and patient is symptomatic
• Patient on drugs that may prolong the PR or QRS interval durations, such as any of the antiarrhythmic medications Class I (Fast sodium (Na) channel blockers)
• Patient unable to readily swallow oral tablets
• Patient with severe gastrointestinal disease (including esophagitis, gastritis, malabsorption)
• Patient with history of gastrectomy
• Patient with uncontrolled diabetes mellitus or unmonitored diabetes mellitus
• Patient with cachexia caused by other reasons, as determined by the investigator such as:
• Severe COPD requiring use of home O2,

Where it is running

• Pacific Cancer Medical Center, Inc — Anaheim, California, United States
• CBCC Global Research Inc — Bakersfield, California, United States
• Compassionate Care Research Group, Inc., at Compassionate Cancer Care Medical Group, Inc. — Fountain Valley, California, United States
• Marin Cancer Care — Greenbrae, California, United States
• Smilow Cancer Hospital at Yale-New Haven — Waterbury, Connecticut, United States
• Bond & Steele Clinic P.A. — Winter Haven, Florida, United States
• Presence Infusion Care — Skokie, Illinois, United States
• Siouxland Regional Cancer Center dba June E.Nylen Cancer Center — Sioux City, Iowa, United States
• Cancer Center of Kansas — Wichita, Kansas, United States
• Cancer and Hematology Centers of Western Michigan — Grand Rapids, Michigan, United States
• Dartmouth-Hitchcock Medical Center — Lebanon, New Hampshire, United States
• New Jersey Hematology Oncology Associates Inc — Brick, New Jersey, United States
• Hunterdon Hematology Oncology LLC — Flemington, New Jersey, United States
• Hematology Oncology Center at Nyack Hospital — Nyack, New York, United States
• University of Rochester, Medical Center — Rochester, New York, United States
• Duke Cancer Center — Durham, North Carolina, United States
• Toledo Clinic Cancer Center-Toledo — Toledo, Ohio, United States
• The University of Texas MD Anderson Cancer Center — Houston, Texas, United States
• Calvary Central Districts Hospital — Elizabeth Vale, South Australia, Australia
• Flinders Medical Centre — Bedford Park, Australia
• St Vincent's Hospital Melbourne — Fitzroy, Australia
• Barwon Health, The McKellar Centre — North Geelong, Australia
• The Royal Melbourne Hospital — Parkville, Australia
• Gold Coast University Hospital — Southport, Australia
• The University of Arizona Cancer Center - North Campus — Tucson, Arizona, United States

Full record on ClinicalTrials.gov

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