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    Summary
    EudraCT Number:2007-002183-99
    Sponsor's Protocol Code Number:INNO-507-P2
    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:2008-03-13
    Trial 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 number2007-002183-99
    A.3Full title of the trial
    A Phase II Study of Oral Tamibarotene in Acute Promyelocytic Leukemia Patients Who Have Received Prior Therapy with ATRA and Arsenic Trioxide (STAR-1)
    A.3.2Name or abbreviated title of the trial where available
    STAR-1
    A.4.1Sponsor's protocol code numberINNO-507-P2
    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 SponsorINNOVIVE PHARMACEUTICALS
    B.1.3.4CountryUnited States
    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 Yes
    D.2.1.1.1Trade name Amnolake Tablets 2mg
    D.2.1.1.2Name of the Marketing Authorisation holderNippon Shinyaku
    D.2.1.2Country which granted the Marketing AuthorisationJapan
    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.3.4Pharmaceutical 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.3.8INN - Proposed INNtamibarotene (arotinoid derivatives P.1.0.0)
    D.3.9.1CAS number 94497-51-5
    D.3.9.2Current sponsor codeINNO-507
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2
    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 Yes
    D.3.11.13.1Other medicinal product typeNon Applicabile
    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
    Acute Promyelocytic Leukemia
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10001019
    E.1.2Term Acute promyelocytic leukaemia
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To determine the rate of durable complete response for tamibarotene therapy when administered as a single agent to adult patients with relapsed or refractory APL.
    E.2.2Secondary objectives of the trial
    (1) To determine the rates of morphologic leukemia-free state, partial response, cytogenetic complete response, and molecular complete response for tamibarotene therapy when administered as a single agent to adult patients with relapsed or refractory APL. (2) To determine the safety profile and tolerability of tamibarotene in the indicated patient population. (3) To determine the pharmacokinetic (PK) profile of tamibarotene when administered in the indicated patient population.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients must meet all of the following criteria for admission into the study: (1) Have a diagnosis of either relapsed and/or refractory APL: - Refractory disease is defined as a confirmed diagnosis of APL and a myeloblast plus promyelocyte count of >10% in the bone marrow in patients who have failed to respond to induction therapy in the first or second line setting. Induction therapy must have included ATRA- and ATO-based therapy given either sequentially or in combination. - Relapsed disease is defined as a confirmed diagnosis of APL and a myeloblast plus promyelocyte count of >10% in the bone marrow following a documented complete remission or positive RT-PCR assay for PML/RAR-alfa in two consecutive tests separated by at least one month, after treatment with ATRA- and ATO-based therapy given either sequentially or in combination. (2) Confirmation of diagnosis and relapsed/refractory APL must be obtained in blood or bone marrow mononuclear cells by at least one of the following methods: - Conventional cytogenetics showing the translocation t(15:17), - Positive RT-PCR assay for PML/RAR-alfa;, or - Fluorescence in situ hybridization (FISH) analysis showing evidence of the PML/RAR-alfa translocation. (3) Patients must have received and failed therapy with ATRA and ATO either within the same or separate induction/consolidation schedule(s). Treatment must have been administered for a minimum of 28 days for each agent. Treatment may have been administered either as combination therapy or sequentially as single agents. Patients who failed to complete a course of induction/consolidation therapy, as specified, due to drug intolerance are eligible for the study. (4) Patients in whom ATO is contraindicated (for example due to congenital long QT syndrome) are eligible for inclusion on study if they have received and failed ATRA therapy as defined in (3). (5) Be able to provide written informed consent prior to enrollment into the study (see Appendix D). (6) Be magior equal to 18 years old. (7) Have an Eastern Cooperative Oncology Group (ECOG) Performance Status of minor equal to 2 (see Appendix B). (8) Have an estimated life expectancy of major equal to 12 weeks. (9) Be male or a non-pregnant, non-lactating female. Fertile patients must agree to use an effective barrier method of contraception (e.g., latex condom, diaphragm, or cervical cap) to avoid pregnancy while on therapy and for 90 days following the discontinuation of the study drug. [In countries where double barrier contraception is required by Regulatory Authorities, patients who are fertile must agree to use 2 forms of barrier method contraception (e.g., latex condom AND a diaphragm or cervical cap) while on therapy and for 90 days following the discontinuation of the study drug.] A non-fertile female is defined as: - Postmenopausal (amenorrheic for major equal to 12 months) - Undergone a complete oophorectomy or hysterectomy. (10) Have a negative serum or urine pregnancy test within 10 days prior to the first dose of study drug (if patient is a female of childbearing potential). (11) Have adequate organ function as indicated by the following laboratory values obtained within 10 days prior to the first dose of study drug as outlined in Table 2. Table 2 Inclusion Laboratory Values Parameter Required Value (units) Hepatic Serum bilirubin minor equal to 1.5 x ULN without leukemic involvement (minor equal to 3.0 x ULN with leukemic involvement) AST and/or ALT minor equal to 2.5 x ULN (minor equal to 5.0 x ULN with leukemic involvement) Alkaline phosphatase minor equal to 2.5 x ULN (minor equal to 5.0 x ULN with leukemic involvement) Renal Serum creatinine or minor equal to 1.5 x ULN 24 h creatinine Cl major equal to 50 mL/min (Patients with a serum creatinine >1.5 ULN will be eligible if the 24 h creatinine clearance is major equal to 50 mL/min.) ULN = Institutional Upper Limit of Normal
    E.4Principal exclusion criteria
    Patients who meet any of the following criteria will be excluded from study admission: (1) Extramedullary leukemia. (2) Patients on a vitamin A preparation or patients with hypervitaminosis A. (3) Have received cytotoxic therapy minor equal to 2 weeks from the start of therapy. If the patient needs these agents due to urgent medical care within 2 weeks prior to starting tamibarotene, a waiver may be granted by the INNOVIVE Medical Monitor. (4) Have a history of myelodysplastic syndromes (MDS). (5) Have impaired cardiac function or clinically significant heart disease including: - myocardial infarction within 3 months, unstable angina pectoris, congenital long QT syndrome and clinically significant resting bradycardia (<50 beats per minute), uncontrolled congestive heart failure, uncontrolled hypertension, history of labile hypertension, or history of poor compliance with antihypertensive medication. (6) Have an active, uncontrolled systemic infection considered opportunistic, life-threatening, or clinically significant at the time of treatment. (7) Have clinically significant acute or chronic liver or renal disease considered unrelated to leukemia. (8) Have uncontrolled hyperlipidemia. (9) Have uncontrolled or poorly controlled diabetes mellitus. (10) Have impaired gastrointestinal function that may significantly alter drug absorption (e.g., uncontrolled vomiting, ulcerative colitis, malabsorption, or small bowel resection). (11) Are pregnant or lactating. (12) Have psychiatric disorder(s) that would interfere with consent, study participation, or follow-up. (13) Have not recovered from acute toxicities of all previous therapy prior to enrollment. (14) Have any other severe concurrent disease and/or uncontrolled medical conditions, which, in the judgment of the investigator, could predispose patients to unacceptable safety risks or compromise compliance with the protocol. (15) Have a history of another primary malignancy that has been actively treated in the last 24 months. (16) Are unwilling or unable to comply with the protocol.
    E.5 End points
    E.5.1Primary end point(s)
    (1) Rate of durable complete response will be assessed according to the response criteria in Section 8. Only patients who meet the CR criteria for a minimum of 28 days will be considered responders. Complete response rates will be assessed at the following timepoints after the end of induction therapy: 28 days, 3 months, 6 months, 9 months, 1 year, and every 6 months thereafter.
    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 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) 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 concerned10
    E.8.5The trial involves multiple Member States Yes
    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 2008-03-13. Yes
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    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 state15
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 31
    F.4.2.2In the whole clinical trial 50
    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 Decision2007-11-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-09-19
    P. End of Trial
    P.End of Trial StatusCompleted
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