Phase II, double blind, placebo controlled, parallel arm, fixed dose, multi-site study to evaluate the safety, feasibility and desirability of conducting a fully powered phase III study of anamorelin for anorexia in people with small cell lung cancer
- Conditions
- AnorexiaSmall cell lung cancerCancer - Lung - Small cellDiet and Nutrition - Other diet and nutrition disorders
- Registration Number
- ACTRN12622000129785
- Lead Sponsor
- niversity of Technology Sydney
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Suspended
- Sex
- All
- Target Recruitment
- 50
18 years of age or more
Documented histologic or cytologic diagnosis of small cell lung cancer (limited – one lung and/or nearby lymph nodes; or extensive disease – extends beyond single lung, and extended to other lymph nodes or other parts of the body)
Newly diagnosed with small cell lung cancer with planned systemic therapy OR first recurrence of disease following successful treatment with a documented disease-free interval of at least 6 months
Less than or equal to 37 points on the 12-item Functional Assessment of Anorexia Cachexia Treatment (FAACT A/CS) scale
Australia-modified Karnofsky Performance status equal to or greater than 50 at screening
Adequate hepatic function [AST (SGOT) and ALT (SGPT) less than or equal to 5 times ULN]
Adequate renal function (calculated creatinine clearance greater than 20 mL/minute)
Female participants shall be: of non-childbearing potential OR of childbearing potential using reliable contraceptive measures AND having a negative urine pregnancy test within 24 hours prior to first dose of investigational product
English-speaking (or have an interpreter available).
The participant must be willing and able to provide written informed consent, and comply with the protocol tests and procedures.
Women who are pregnant OR breastfeeding
Pathology and causes that may impede food intake, as determined by the Investigator. These causes may include but are not limited to: Grade 3 or 4 oral mucositis; Grade 3 or 4 GI disorders (nausea, vomiting, diarrhea, and constipation); OR mechanical obstructions making the person unable to eat.
Having undergone major surgery (central venous access placement and tumor biopsies are not considered major surgery) within 4 weeks prior to randomisation. Potential participants must be recovered from acute effects of surgery prior to screening. Participants should not have a current treatment plan to undergo major surgical procedures during the treatment period.
Currently taking androgenic compounds (including but not limited to testosterone, testosterone-like agents, oxandrolone, megestrol acetate, methylphenidate, corticosteroids), olanzapine, prokinetics (including metoclopramide), dronabinol or medical marijuana (medical cannabis) or any other prescription medication or off-label products intended to increase appetite or treat unintentional weight loss [e.g. melatonin, nabilone, delta-9-tetrahydrocannabinol (THC) and cannabidiol (CBD)] – With the exception when any of these medications are administered (short-term) as part of routine chemotherapy/ radiation therapy standard protocols.
On mirtazapine in the previous four weeks.
Pleural effusion requiring thoracentesis.
Pericardial effusion requiring drainage.
Oedema requiring regular diuretics.
Ascites requiring drainage.
Uncontrolled or significant cardiovascular disease, including but not limited to: history of myocardial infarction within the past 3 months; A-V block of second or third degree (but eligible if currently has a pacemaker – with the exception that BIA will not be performed if the person has a pacemaker, due to minor electrical current); unstable angina; congestive heart failure within the past 3 months, if defined as New York Heart Association (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 >160 mmHg systolic and >100 mmHg diastolic); heart rate < 50 beats per minute on pre-entry electrocardiogram and participant is symptomatic.
Taking regular medications that may prolong the PR or QRS interval durations, such as any of the antiarrhythmic medications Class I [fast sodium (Na) channel blockers (e.g. quinidine, disopyramide, procainamide, lidocaine, phenytoin, flecainide, propafenone)].
Unable to swallow oral tablets.
Severe gastrointestinal disease (including oesophagitis, gastritis, malabsorption).
History of a gastrectomy.
Recent history of radiotherapy of oesophagus area.
Diabetes mellitus with secondary organ dysfunction (coronary heart disease, previous stroke, renal insufficiency), or poorly controlled diabetes (patients with glycosylated haemoglobin – HbA1c greater than7% or hyperglycaemia – measured as a fasting blood glucose greater than7mmol/L or a random blood glucose greater than11mmol/L) despite receiving clinic-based diabetes care.
1Diagnosis of anorexia caused by other reasons, as determined by the investigator such as: advanced AIDS; heart failure; uncontrolled thyroid disease.
Receiving strong CYP3A4 inhibitors (including clarithromycin, erythromycin, diltiazem, itraconazole, ketoconazole, ritonavir, ver
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method