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
- Conditions
- cachexiawasting syndroom1000301810027656
- Registration Number
- NL-OMON37977
- Lead Sponsor
- Helsinn Therapeutics (U.S.), Inc
- Brief Summary
Trial is onging in other countries
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 2
• Females and males at least 18 years of age
• Documented histologic or cytologic diagnosis of AJCC Stage III or IV NSCLC. Stage III patients must have unresectable disease.
• With regard to chemotherapy and/or radiation therapy:
o Patients may be receiving maintenance chemotherapy.
o Patients planning to initiate a new chemotherapy and/or radiation therapy
regimen may do so only within ±14 days of randomization.
o 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 BMI <20 kg/m2. Weights may have been measured or obtained and documented by patient history.
• Body mass index *30 kg/m2
• ECOG performance status *2 (Appendix I)
• Estimated life expectancy of >4 months at the time of screening
• Adequate hepatic function, defined as aspartate aminotransferase (AST) and alanine aminotransferase (ALT) levels *5 * upper limit of normal (ULN)
• Adequate renal function, defined as creatinine *2 * ULN, or calculated creatinine clearance *30 ml/minute
• The patient is able to understand and comply with the procedures for the Hand Grip Strenght evaluation
• If the patient is 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 medication (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.
• Other forms of lung cancer (eg, small cell, mesothelioma)
• Women who are pregnant or breast-feeding
• Known HIV, hepatitis (B & C), or active tuberculosis
• Patients who are currently actively receiving chemotherapy and/or radiation therapy for disease treatment. Patients must not be planning to initiate chemotherapy and/or radiation therapy in the middle of the 12-week treatment period at the time of randomization.
• Had 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;
• Patients unable to readily swallow oral tablets. Patients with severe gastrointestinal disease 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
• Patients receiving strong CYP3A4 inhibitors within 14 days of randomization
• Patients 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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>To evaluate the effect of Anamorelin HCl on lean body mass as measured by dual<br /><br>energy X-ray absorptiometry (DXA)<br /><br>To evaluate the effect of Anamorelin HCl on muscle strength as measured by<br /><br>handgrip strength</p><br>
- Secondary Outcome Measures
Name Time Method <p>To evaluate the effect of Anamorelin HCl on body weight<br /><br>To evaluate the effect of Anamorelin HCl on quality of life as assessed using<br /><br>the FAACT (Functional Assessment of Anorexia/Cachexia Treatment) and the<br /><br>FACIT-F (Functional Assessment of Chronic Illness Therapy - Fatigue)<br /><br>To evaluate the effect of Anamorelin HCl on overall survival<br /><br>To evaluate the safety and tolerability of Anamorelin HCl<br /><br>To evaluate the effect of Anamorelin HCl on quality of life as assessed using<br /><br>the<br /><br>Hunger Assessment Scale (see Appendix IV)</p><br>