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    Summary
    EudraCT Number:2018-002927-40
    Sponsor's Protocol Code Number:ANAM-17-21
    National Competent Authority:Romania - National Agency for Medicines and Medical Devices
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2022-03-01
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedRomania - National Agency for Medicines and Medical Devices
    A.2EudraCT number2018-002927-40
    A.3Full title of the trial
    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)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    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)
    A.4.1Sponsor's protocol code numberANAM-17-21
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorHelsinn Healthcare SA
    B.1.3.4CountrySwitzerland
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportHelsinn Healthcare SA
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationHelsinn Healthcare SA
    B.5.2Functional name of contact pointMichele Dubini
    B.5.3 Address:
    B.5.3.1Street AddressVia Pian Scairolo 9
    B.5.3.2Town/ cityLugano
    B.5.3.3Post code6912
    B.5.3.4CountrySwitzerland
    B.5.4Telephone number+4191985 21 21
    B.5.5Fax number+4191993 21 22
    B.5.6E-mailmichele.dubini@helsinn.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameAnamorelin
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNANAMORELIN
    D.3.9.1CAS number 249921-19-5
    D.3.9.2Current sponsor code05-ANAM
    D.3.9.4EV Substance CodeSUB178986
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboFilm-coated tablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Treatment of malignancy associated weight loss or anorexia in patients with NSCLC
    E.1.1.1Medical condition in easily understood language
    Weight loss or anorexia in patients with non-small cellular lung cancer
    E.1.1.2Therapeutic area Diseases [C] - Nutritional and Metabolic Diseases [C18]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To demonstrate superiority of anamorelin HCl vs placebo on the gain in body weight and improvement in anorexia symptoms
    E.2.2Secondary objectives of the trial
    To evaluate the safety and tolerability of anamorelin HCl
    E.2.3Trial contains a sub-study No
    E.3Principal 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:
    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
    E.4Principal 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:
    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 loss6. 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
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint is the occurrence of Composite Clinical Response (CCR) at 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.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 0, week 9
    E.5.2Secondary end point(s)
    Change in body weight 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
    Change in FAACT total score from baseline to Week 9
    E.5.2.1Timepoint(s) of evaluation of this end point
    Week 9
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned7
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA35
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Australia
    Russian Federation
    United States
    Belgium
    Croatia
    Germany
    Poland
    Romania
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 211
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 105
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state65
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 160
    F.4.2.2In the whole clinical trial 316
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    Treatment of standard of care
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2019-12-31
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-04-24
    P. End of Trial
    P.End of Trial StatusOngoing
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