Study to Evaluate the Efficacy and Safety of Anamorelin HCl for the Treatment of Malignancy Associated Weight Loss and Anorexia in patients with Advanced Non-Small Cell Lung Cancer (NSCLC)
- Conditions
- Treatment of malignancy associated weight loss or anorexia in patients with NSCLCTherapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]
- Registration Number
- EUCTR2018-002927-40-DE
- Lead Sponsor
- Helsinn Healthcare SA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 316
1. Signed written informed consent
2. Female or male =18 years of age
3. Documented histologic or cytologic diagnosis of American Joint Committee on Cancer (AJCC) Stage III or IV NSCLC. Stage III patient must have unresectable disease
4. Body mass index < 20 kg/m2 with involuntary weight loss of >2% within 6 months prior to screening
5. 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
6. 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:
a. 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
b. 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
c. Patient on palliative care treatment
7. ECOG performance status 0,1 or 2 at screening
8. AST (SGOT) and ALT (SGPT) = 3 x ULN or if hepatic metastases are present = 5 x ULN
9. Adequate renal function, defined as creatinine =2 x ULN, or calculated creatinine clearance >30 ml/minute
10. 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
11. The patient must be willing and able to comply with the protocol tests and procedures
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 211
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 105
1. Patient with other forms of lung cancer (e.g., small cell, neuroendocrine tumors)
2. Woman who is pregnant or breast-feeding
3. Reversible causes of reduced food intake, as determined by the Investigator. These causes may include but are not limited to:
a. NCI CTCAE Grade 3 or 4 oral mucositis,
b. NCI CTCAE Grade 3 or 4 GI disorders [nausea, vomiting, diarrhea, and constipation],
c. mechanical obstructions making patient unable to eat,
or
d. severe depression
4. 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
5. 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
6. Patient with pleural effusion requiring thoracentesis, pericardial effusion requiring drainage, edema or evidence of ascites
7. Patient with uncontrolled or significant cardiovascular disease, including:
a. History of myocardial infarction within the past 3 months
b. A-V block of second or third degree (may be eligible if currently have a pacemaker)
c. Unstable angina
d. Congestive heart failure within the past 3 months, if defined as NYHA class III-IV
e. Any history of clinically significant ventricular arrhythmias (such as ventricular tachycardia, ventricular fibrillation, Wolff-Parkinson-White (WPW) syndrome, or torsade de pointes)
f. Uncontrolled hypertension (blood pressure >150 mm Hg systolic and >95 mm Hg diastolic)
g. Heart rate < 50 beats per minute on pre-entry electrocardiogram and patient is symptomatic
8. 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)
9. Patient unable to readily swallow oral tablets
10. Patient with severe gastrointestinal disease (including esophagitis, gastritis, malabsorption)
11. Patient with history of gastrectomy
12. Patient with uncontrolled diabetes mellitus or unmonitored diabetes mellitus
13. Patient with cachexia caused by other reasons, as determined by the investigator such as:
a. Severe COPD requiring use of home O2,
b. New York Heart Association (NYHA) class III-IV heart failure
c. AIDS
d. Uncontrolled thyroid disease
14. Patient receiving strong CYP3A4 inhibitors within 14 days of randomization
15. Patient currently receiving tube feedings or parenteral nutrition (either total or partial).
16. Current excessive alcohol or illicit drug use
17. Any condition, including the presence of laboratory abnormalities, which in the Investigator’s opinion, places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study
18. Enrollment in a previous study with anamorelin HCl
19. Patient actively receiving a concurrent investigational agent, or having received an investigational agent within 28 days of Day 1
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To demonstrate superiority of anamorelin HCl vs placebo on the gain in body weight and improvement in anorexia symptoms;Secondary Objective: To evaluate the safety and tolerability of anamorelin HCl;Primary end point(s): Duration of clinically meaningful treatment benefit in weight until Week 12.<br>Duration of clinically meaningful treatment benefit in 5-item Anorexia Symptom Subscale until Week 12.;Timepoint(s) of evaluation of this end point: Week 12
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Mean change in body weight from baseline up to Week 12.<br>Mean change in 5-item Anorexia Symptom Subscale up to Week 12.<br>Mean change in FAACT total score from baseline up to Week 12.;Timepoint(s) of evaluation of this end point: Week 12