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)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03743051|
Recruitment Status : Recruiting
First Posted : November 15, 2018
Last Update Posted : December 4, 2020
|Condition or disease||Intervention/treatment||Phase|
|Cachexia; Cancer Non Small Cell Lung Cancer||Drug: Anamorelin Hydrochloride Drug: Placebo Oral Tablet||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||316 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Randomized, Double-Blind, Placebo-Controlled, Multicenter Study|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Phase 3 Randomized, Double-Blind, Placebo-Controlled, Multicenter 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)|
|Actual Study Start Date :||December 18, 2018|
|Estimated Primary Completion Date :||September 2021|
|Estimated Study Completion Date :||March 2022|
|Experimental: 100mg Anamorelin HCl||
Drug: Anamorelin Hydrochloride
100 mg anamorelin HCl (administered as 100 mg tablets in the fasted condition)
|Placebo Comparator: placebo||
Drug: Placebo Oral Tablet
Placebo (administered as matching placebo tablets in the fasted condition)
- Composite Clinical Response (CCR) [ Time Frame: from baseline to week 9 ]CCR is a composite measure including both a ≥ 5% body weight gain from baseline and increase ≥ 2 points (meaning a clinically relevant improvement) in the 5-item Anorexia Symptom Scale score from baseline) in patients who survive until Day 64.
- body weight [ Time Frame: from baseline to week 9 ]Change in body weight from baseline to Week 9
- 5 item Anorexia Symptom Scale [ Time Frame: from baseline to week 9 ]Change in patient-reported anorexia symptoms from baseline to Week 9 as measured by the 5 item Anorexia Symptom Scale. The 5 item Anorexia Symptom Scale ranges from 0 to 20, higher score indicates better condition regarding anorexia symptoms.
- FAACT total score [ Time Frame: from baseline to week 9 ]Change in FAACT total score from baseline to week 9. FAACT total score (Functional Assessment of Anorexia Cachexia Treatment total score) is the sum of the scores FACT-G (Functional Assessment of Cancer Therapy - General) and FAACT A/CS domain (Functional Assessment Anorexia Cachexia Therapy Anorexia Cachexia Subscale domain). The FACT-G is the sum of the Physical Well-Being (ranging from 0 to 28), the Social/Family Well-Being (ranging from 0 to 28), the Emotional Well-Being (ranging from 0 to 24) and the Functional Well-Being (ranging from 0 to 28). The FAACT A/CS domain ranges from 0 to 48. The FAACT total score ranges from 0 to 156, higher score indicates better condition.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03743051
|Contact: Edwin De Wit, MD||0041 email@example.com|