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    Summary
    EudraCT Number:2019-003622-25
    Sponsor's Protocol Code Number:RP6530-1901
    National Competent Authority:Poland - Office for Medicinal Products
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2019-10-07
    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 ConcernedPoland - Office for Medicinal Products
    A.2EudraCT number2019-003622-25
    A.3Full title of the trial
    A Phase 2, Open label Study to Assess the Efficacy and Safety of Tenalisib
    (RP6530), a Novel PI3K Dual δ/γ Inhibitor, in Patients with
    Relapsed/Refractory Chronic Lymphocytic Leukemia (CLL)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Phase 2, Open label Study to Assess the Efficacy and Safety of Tenalisib
    (RP6530) in Patients with Relapsed/Refractory Chronic Lymphocytic
    Leukemia (CLL)
    A.3.2Name or abbreviated title of the trial where available
    Not applicable
    A.4.1Sponsor's protocol code numberRP6530-1901
    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 SponsorRhizen Pharmaceuticals 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 supportRhizen Pharmaceuticals SA
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationRhizen Pharmaceuticals SA
    B.5.2Functional name of contact pointAjit Nair / SVP & Head Clinical R&D
    B.5.3 Address:
    B.5.3.1Street AddressFritz-Courvoisier 40
    B.5.3.2Town/ cityLa Chaux-de-Fonds
    B.5.3.3Post codeCH-2300
    B.5.3.4CountrySwitzerland
    B.5.4Telephone number+414033241041
    B.5.6E-mailan@rhizen.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 nameTenalisib
    D.3.2Product code RP6530
    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 INNTenalisib
    D.3.9.2Current sponsor codeRP6530
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number400
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Relapsed/Refractory Chronic Lymphocytic Leukemia (CLL)
    E.1.1.1Medical condition in easily understood language
    Refractory Chronic Lymphocytic Leukemia
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level LLT
    E.1.2Classification code 10008976
    E.1.2Term Chronic lymphocytic leukemia
    E.1.2System Organ Class 100000004864
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the anti-tumor activity of Tenalisib as determined by the
    objective response rate (ORR) and duration of response (DoR)
    E.2.2Secondary objectives of the trial
    • To characterize safety and tolerability of Tenalisib.
    • To assess progression free survival (PFS)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients must meet all the following inclusion criteria to be eligible for participation in this study:
    1. Patients with diagnosis of B-cell CLL as confirmed by histopathology or flow cytometry.
    2. Disease status defined as refractory to or relapsed after at least one prior therapy.
    3. Presence of measurable lymphadenopathy, defined as the presence of > 1 nodal lesion that measures ≥ 1.5 cm in the longest diameter (LD) as assessed by computed tomography (CT).
    4. ECOG performance status ≤ 2.
    5. Male or female ≥ 18 years of age.
    6. Life expectancy of at least 3 months.
    7. Adequate bone marrow (BM), liver, and renal function as assessed by the following laboratory requirements conducted within 14 calendar days before starting study treatment.
    a. Adequate bone marrow function.
    I. Haemoglobin ≥ 9 g/dl
    II. Absolute neutrophil count (ANC) ≥ 1 x 10^9/L
    III. Platelets ≥50 x 10^9/L
    Patients with hemoglobin, neutrophil and platelet counts below the above specified values will be eligible if it is due to tumor dissemination or infiltration to bone marrow and as per physician’s discretion. Hemoglobin and platelet requirements should not be met by use of recent transfusion or growth factor support (G-CSF or erythropoietin) within 3 weeks prior to assessment.
    b. Adequate liver function.
    I. Total bilirubin ≤1.5 times the upper limit of normal (ULN)
    II. ALT and AST should be ≤ 3 x ULN. ALT and AST ≤ 5 x ULN if known liver involvement.
    c. Adequate renal function: Calculated creatinine clearance ≥ 50 mL/min (as calculated by the Cockcroft-Gault method) or Creatinine ≤ 1.5 mg/dl.
    8. Ability to swallow and retain oral medication.
    9. Female patients who are not of child-bearing potential, and female patients of child-bearing potential should have a negative serum pregnancy test within 3 days prior to Cycle 1 Day 1 (C1D1). Female patients of child-bearing potential must consent to use a medically acceptable method of contraception as defined in Appendix A , throughout the study period and for 30 days after the last dose of study drug.
    10. Male patients willing to use adequate contraceptive measures throughout the study period and for 12 weeks after the last dose of Tenalisib.
    11. Willingness and ability to comply with trial and follow-up procedures and give written informed consent.
    E.4Principal exclusion criteria
    1. Patient with Richter’s (large cell) transformation, or prolymphocytic leukemia (PLL) transformation.
    2. Patients receiving any cancer therapy (i.e., chemotherapy, radiation therapy, immunotherapy and biologic therapy) or any cancer investigational drug within 3 weeks (21 days) or 5 half-lives (whichever is shorter) prior to C1D1.
    3. Prior exposure to drug that specifically inhibits PI3K (e.g. idelalisib, copanlisib, duvelisib, umbralisib)
    4. Patient with autologous / allogeneic stem cell transplant (ASCT/Allo-SCT) receiving treatment for active graft versus-host disease (GVHD).
    5. Evidence of ongoing severe systemic bacterial, fungal or viral infection as assessed by the investigator.
    6. Central nervous system (CNS) involvement of leukemia or lymphoma
    7. Ongoing immunosuppressive therapy including systemic corticosteroids except as allowed per concomitant medication (Section 5.2).
    8. Known history of severe liver injury including drug-induced liver injury (e.g. alcoholic liver disease, primary biliary cirrhosis, ongoing extrahepatic obstruction caused by stones, cirrhosis of the liver or portal hypertension) as judged by investigator;
    9. Any severe and/or uncontrolled medical conditions or other conditions that could affect patient participation in the study, as judged by investigator, such as:
    a. Symptomatic or history of documented congestive heart failure (New York heart association (NYHA) functional classification III-IV)
    b. Myocardial infarction within 6 months of C1D1
    c. QTcF >470 msec.
    d. Angina not well-controlled by medication.
    e. Poorly controlled atherosclerotic vascular disease (e.g. cerebrovascular accident, transient ischemic attack, angioplasty, cardiac/vascular stenting).
    10. Patient treated for other malignancy in last 3 years of study enrollment except for adequately treated basal, squamous cell carcinoma or non-melanomatous skin cancer, carcinoma in situ of the cervix, superficial bladder cancer not treated with intravesical chemotherapy or BCG within 6 months; and localized prostate cancer with PSA <1.0 mg/dL within 4 weeks of C1D1.
    11. Women who are pregnant or lactating.
    12. Known seropositive requiring anti-viral therapy for human immunodeficiency virus (HIV) infection.
    13. Known seropositive requiring anti-viral therapy for hepatitis B virus (HBV) infection OR evidence of active hepatitis B infection as defined by detectable viral load if the antibody tests are positive. [Note: Subject with a positive HBcAb with an undetectable/negative hepatitis B DNA test (e.g., polymerase chain reaction [PCR] test) can be enrolled].
    14. Known seropositive requiring anti-viral therapy for hepatitis c virus (HCV) infection OR patients with positive hepatitis C virus Ab with detectable viral load. [Note: Subject with a positive HCV with an undetectable/negative hepatitis C RNA test (e.g., PCR) can be enrolled].
    15. Known seropositive requiring anti-viral therapy for active CMV infection (Note: A serology positive CMV subject with negative CMV PCR test will be enrolled).
    16. Unresolved NCI-CTCAE grade 2 and above toxicity (except as mentioned in adequate organ function (Refer inclusion criteria #7) attributed to any prior therapy/procedure excluding alopecia.
    17. Inability or unwillingness to comply with study and/or follow-up procedures outlined in the protocol;
    18. Concurrent condition that in the investigator’s opinion would jeopardize compliance with the protocol.
    E.5 End points
    E.5.1Primary end point(s)
    Efficacy:
    • Overall response rate (ORR): ORR is defined as sum of complete
    response (CR) and partial response (PR) rates as defined by iwCLL
    guideline for CLL (Hallek et al. 2018).
    • Duration of response (DoR): DoR is defined as the interval from the
    first documentation of CR/PR to first documentation of definitive disease
    progression or death from any cause.
    • Progression-free survival (PFS): PFS is defined as the interval from
    first dose to first documentation of definitive disease progression or
    death from any cause.
    Safety:
    • Adverse Event (AE), Grade 3/ 4 AEs, Serious Adverse Event (SAE).
    E.5.1.1Timepoint(s) of evaluation of this end point
    End of Treatment
    E.5.2Secondary end point(s)
    To characterize safety and tolerability of Tenalisib.
    To assess progression free survival (PFS).
    E.5.2.1Timepoint(s) of evaluation of this end point
    End of Treatment
    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 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) 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 Yes
    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) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    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 Yes
    E.8.5.1Number of sites anticipated in the EEA6
    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
    Bulgaria
    Georgia
    Poland
    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 years2
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    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: 20
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 41
    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 state37
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 51
    F.4.2.2In the whole clinical trial 61
    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)
    If in the opinion of the Investigator the patient is continuing to benefit from the study treatment, they may be able to enrol into a subsequent study and continue to receive Tenalisib.
    For other cases, the study doctor will discuss treatment choices with the patient.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2019-12-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-10-15
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2020-10-02
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