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    Summary
    EudraCT Number:2008-001382-28
    Sponsor's Protocol Code Number:INCB 18424-256
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2008-10-01
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2008-001382-28
    A.3Full title of the trial
    A Phase 2, open label, dose regimen ranging clinical study to determine the safety and efficacy of INCB018424 in patients with advanced polycythemia vera or essential thrombocythemia refractory to hydroxyurea
    A.3.2Name or abbreviated title of the trial where available
    ND
    A.4.1Sponsor's protocol code numberINCB 18424-256
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberND
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorIncyte Corporation
    B.1.3.4CountryUnited Kingdom
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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.3.2Product code INCB018424
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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.IMP: 2
    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.3.2Product code INCB018424
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    advanced polycythemia vera or essential thrombocythemia refractory to hydroxyurea
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10036057
    E.1.2Term Polycythaemia vera
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10015494
    E.1.2Term Essential thrombocythemia
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the safety and efficacy profile of three different treatment regimens of INCB018424 administered to two groups of patients; those with polycythemia vera (PV) and those with essential thrombocythemia (ET). Patients in each group will be refractory to hydroxyurea or for whom hydroxyurea is contraindicated.
    E.2.2Secondary objectives of the trial
    To evaluate the relationship of changes in plasma and whole blood PD biomarkers; JAK2V617F burden in blood; and morphological, cytogenetic, and mutational status of the bone marrow to clinical outcome and to plasma concentrations of INCB018424 To evaluate the quality of life (QOL) in each patient population by specifically assessing symptoms associated with PV and ET and by using the validated EORTC QLQC30, and by evaluating the relationship of changes in those measures to treatment response
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Must be at least 18 years of age 2. Confirmed diagnosis of polycythemia vera or essential thrombocythemia as determined by treating physician (Guidelines in Appendix 10 and 11) 3. Patients should have disease refractory to hydroxyurea or for whom treatment with hydroxyurea is contraindicated as determined by the treating physician. Disease must be assessed within 21 days prior to treatment initiation. or Patients who have refused further treatment with hydroxyurea due to side effects. These patients must have had a trial with hydroxyurea, and the treating physician must concur that discontinuing hydroxyurea is in the best interest of the patient. 4. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2 5. Required baseline laboratory data include: a) Hct > 45% for PV or phlebotomy required two times in prior six months with at least one occurrence in prior three months b) Platelet count &#8805; 125 x 109/L for PV patients c) Platelet count > 650 x109/L for ET patients unless receiving treatment d) Absolute neutrophil count (ANC) &#8805; 1.2 x 109/L for both patient groups e) Total bilirubin &#8804; 2 x institutional upper limit of normal (ULN) for both patient groups f) Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) &#8804; 2.5 x ULN for both patient groups g) Serum creatinine &#8804; 2 x ULN for both patient groups 6. Females will be either postmenopausal for at least 1 year with documented follicle stimulating hormone (FSH) > 30 IU/L or surgically sterile for at least 3 months OR females of childbearing potential who agree to take appropriate precautions to avoid pregnancy (with at least 99% certainty) from Screening through Follow-up. (Note: Permitted methods which are at least 99% effective in preventing pregnancy should be communicated to the subjects and their understanding confirmed). For all females, the urine pregnancy test result must be negative at Screening. Males must agree to take appropriate precautions to avoid fathering a child (with at least 99% certainty) from Screening through Follow-up. (Note: Permitted methods which are at least 99% effective in preventing pregnancy should be communicated to the subjects and their understanding confirmed.) 7. Is able to comprehend and is willing to sign an informed consent form, indicating that the patient is aware of the nature of the disease and has been informed of the procedures to be followed, the experimental nature of the therapy, alternatives, potential benefits, side effects, risks, and discomfort. 8. Willing and able to comply with scheduled visits, treatment plan and laboratory tests.
    E.4Principal exclusion criteria
    Females who are pregnant or are currently breastfeeding 2. Treatment with interferon alpha or anagrelide within 7 days and hydroxyurea within 1 day of starting INCB018424. All other cytoreductive therapies for PV or ET or investigational medications must be discontinued within 28 days of enrollment. 3. Patients diagnosed with another malignancy unless the malignancy was cervical intraepithelial neoplasia or basal or squamous cell skin cancer and the patient has been disease free for > 3 years, unless approved by Sponsor. 4. Patients receiving therapy with intermediate or high dose steroids greater than the equivalent of 10 mg prednisone per day 5. Patients with known active hepatitis A, B, C or known positivity for HIV 6. Uncontrolled inter-current illness or has any concurrent condition that, in the Investigator’s opinion, would jeopardize the safety of the patient or compliance with the protocol. 7. Clinically significant cardiac disease (NYHA Class III or IV) 8. Incomplete recovery from any prior surgical procedures or had surgery within 4 weeks prior to study entry 9. Presence of acute active infection requiring systemic antimicrobials 10. Any current or planned therapy with CYP3A4 inhibitors or inducers unless approved by the Sponsor 11. Prior treatment with any oral JAK inhibitor is not permitted unless agreed to by both the investigator and the Sponsor.
    E.5 End points
    E.5.1Primary end point(s)
    Primary Endpoints for PV Patients 1. Complete, partial and overall (CR + PR) response rates will be assessed for all PV patients treated with INCB018424. Response will be assessed at individual time points, but to be a confirmed response, it must be sustained for at least 2 months. Safety and tolerability as assessed by monitoring frequency, duration, and severity of adverse events graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v3, and the results of laboratory, electrocardiogram findings, vital sign measurements and physical examinations. Primary Endpoints for ET Patients 1. Complete, partial and overall (CR+PR) response rates will be assessed for all ET patients treated with INCB018424. Response will be assessed at individual time points but to be a confirmed response it must be sustained for at least 2 months. Safety and tolerability as assessed by monitoring frequency, duration, and severity of adverse events graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v3, and the results of laboratory, electrocardiogram findings, vital sign measurements and physical examinations.
    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 No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    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) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    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 concerned4
    E.8.5The trial involves multiple Member States No
    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 Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months0
    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.1.3Elderly (>=65 years) Yes
    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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2008-10-01. Yes
    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 state54
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 54
    F.4.2.2In the whole clinical trial 105
    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 Decision2008-09-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-08-11
    P. End of Trial
    P.End of Trial StatusCompleted
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