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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)

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ClinicalTrials.gov Identifier: NCT03743051
Recruitment Status : Recruiting
First Posted : November 15, 2018
Last Update Posted : February 8, 2019
Sponsor:
Information provided by (Responsible Party):
Helsinn Healthcare SA

Brief Summary:
Multicenter, randomized, double-blind, parallel-group, placebo-controlled study to evaluate the efficacy and safety of anamorelin HCl. Approximately 316 patients with advanced NSCLC with cachexia will be randomized 1:1 to anamorelin HCl 100 mg or placebo, taken orally once daily (QD) for a total of 24 weeks. Patients will be instructed to take the study drug at least 1 hour before their first meal of the day

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized, Double-Blind, Placebo-Controlled, Multicenter Study
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 : December 2020
Estimated Study Completion Date : July 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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)




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. body weight [ Time Frame: from baseline to week 9 ]
    Change in body weight from baseline to Week 9

  2. 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.

  3. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  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:

    1. 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
    2. 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
    3. 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 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.

    Notes:

    1. 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.
    2. Reliable contraceptive measures include implants, injectables, combined oral contraceptives, intrauterine devices, vasectomized partner or complete (long term) sexual abstinence.
  11. 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).

Exclusion Criteria:

  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:

    1. NCI CTCAE Grade 3 or 4 oral mucositis,
    2. NCI CTCAE Grade 3 or 4 GI disorders [nausea, vomiting, diarrhea, and constipation],
    3. mechanical obstructions making patient unable to eat, or
    4. 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:

    1. History of myocardial infarction within the past 3 months
    2. A-V block of second or third degree (may be eligible if currently have a pacemaker)
    3. Unstable angina
    4. Congestive heart failure within the past 3 months, if defined as NYHA class III-IV
    5. Any history of clinically significant ventricular arrhythmias (such as ventricular tachycardia, ventricular fibrillation, Wolff-Parkinson-White (WPW) syndrome, or torsade de pointes)
    6. Uncontrolled hypertension (blood pressure >150 mm Hg systolic and >95 mm Hg diastolic)
    7. 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:

    1. Severe COPD requiring use of home O2,
    2. New York Heart Association (NYHA) class III-IV heart failure
    3. AIDS
    4. 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 All exclusion criteria will be checked at screening visit (Visit 1).

Information from the National Library of Medicine

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


Contacts
Contact: Ruben Giorgino, MD 0041 919852161 ruben.giorgino@helsinn.com

Locations
United States, Florida
21st Century oncology Recruiting
Jacksonville, Florida, United States, 32204
mid Florida hematology and Oncology Center Recruiting
Orange City, Florida, United States, 32763
United States, New York
North Shore Hematology Oncology Associates DBA NY Cancer and Blood Specialist Recruiting
East Setauket, New York, United States, 11733
United States, Pennsylvania
Gettysburg Cancer Center Recruiting
Gettysburg, Pennsylvania, United States, 17325
Sponsors and Collaborators
Helsinn Healthcare SA

Responsible Party: Helsinn Healthcare SA
ClinicalTrials.gov Identifier: NCT03743051     History of Changes
Other Study ID Numbers: ANAM-17-20
2018-002926-22 ( EudraCT Number )
First Posted: November 15, 2018    Key Record Dates
Last Update Posted: February 8, 2019
Last Verified: November 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Weight Loss
Anorexia
Cachexia
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Body Weight Changes
Body Weight
Signs and Symptoms
Signs and Symptoms, Digestive
Emaciation