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    Summary
    EudraCT Number:2021-001205-73
    Sponsor's Protocol Code Number:IMP4297-202
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2021-05-03
    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 ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2021-001205-73
    A.3Full title of the trial
    A Randomized, Double-Blinded, Placebo-Controlled, Multicenter, Phase II Study to Evaluate Senaparib Maintenance in mCRPC Patients with Homologous Recombination Repair Gene Alterations after Docetaxel Treatment
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    The metastatic castration-resistant prostate cancer (mCRPC) patients with homologous recombination repair (HRR) gene alterations who have not progressed after docetaxel therapy
    A.4.1Sponsor's protocol code numberIMP4297-202
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT04822961
    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 SponsorIMPACT Therapeutics, Inc.
    B.1.3.4CountryChina
    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 supportIMPACT Therapeutics, Inc.
    B.4.2CountryChina
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationIMPACT Therapeutics, Inc.
    B.5.2Functional name of contact pointXingxing Zhang
    B.5.3 Address:
    B.5.3.1Street AddressRoom 603, Building 3, xiangke Road 111
    B.5.3.2Town/ cityShanghai
    B.5.3.3Post code201210
    B.5.3.4CountryChina
    B.5.6E-mailxingxing.zhang@impacttherapeutics.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 nameSenaparib
    D.3.2Product code IMP4297
    D.3.4Pharmaceutical form Capsule
    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 INNSenaparib
    D.3.9.1CAS number 1401682-78-7
    D.3.9.2Current sponsor codeIMP4297
    D.3.9.4EV Substance CodeSUB218614
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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 placeboCapsule
    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
    metastatic castration-resistant prostate cancer (mCRPC)
    E.1.1.1Medical condition in easily understood language
    metastatic prostate cancer
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10036909
    E.1.2Term Prostate cancer metastatic
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10076506
    E.1.2Term Castration-resistant prostate cancer
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    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 impact of Senaparib maintenance on radiographic progression free survival (rPFS), compared with the placebo, in metastatic castration-resistant prostate cancer (mCRPC) patients with Breast cancer susceptibility gene (BRCA) 1/2 gene alteration who have not progressed after docetaxel therapy assessed by Blinded Independent Central Review (BICR)
    E.2.2Secondary objectives of the trial
    Key secondary objectives
    To evaluate the impact of Senaparib maintenance on:
    • rPFS, in mCRPC patients with homologous recombination repair (HRR) gene alterations who have not progressed after docetaxel therapy,
    assessed by BICR
    • time to pain progression, in mCRPC patients with BRCA1/2 gene alteration who have not progressed after docetaxel therapy
    • time to the first symptomatic skeletal related events (SSRE), in mCRPC patients with BRCA1/2 gene alteration who have not progressed after docetaxel therapy
    • overall survival (OS), in mCRPC patients with BRCA1/2 gene alteration who have not progressed after docetaxel therapy.
    For other secondary objectives please refer to the Protocol.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients are eligible to be included in the study only if all the following criteria are met (* is for screening part 1, all criteria for screening part 2)
    1. Patients must voluntarily participate in this clinical study. Be willing and able to provide
    written informed consent form (ICF) prior to any study activity.
    2. Male ≥18 years of age on the day of signing the ICF.
    3. Patients must have histologically or cytologically confirmed prostate adenocarcinoma.
    4. Patients must have received and failed at least one novel hormonal agent (NHA, such as abiraterone, enzalutamide, etc.). In addition, patients are allowed to have received and failed up to one novel hormonal therapy in mCRPC stage. Treatment failure is judged by the investigator.
    5. Patients confirmed by investigator to be at mCRPC stage when starting the immediate prior treatment with docetaxel. Metastatic disease documented by positive bone scan or metastatic lesions on CT or MRI. Metastatic lesions do not include disease spread to local pelvic lymph nodes or local disease recurrence (e.g., bladder and rectum).
    6. Surgically or medically castrated, with serum testosterone levels of ≤50 ng/dL (≤1.73 nmol/L). If the patient is being treated with LHRH agonists/antagonists (patient who have not undergone orchiectomy), this therapy must be continued throughout the study.
    7. Completed at least 6 cycles and a maximum of 8 cycles of immediate prior treatment with docetaxel (3 weeks a cycle) or completed at least 9 cycles and a maximum of 12 cycles of immediate prior treatment with docetaxel (2 weeks a cycle) with no evidence of PD after last docetaxel treatment.
    For further details on this criteria please refer to the protocol.
    8. Documented germline/somatic mutation in at least one of the homologous recombination repair genes, including BRCA1, BRCA2, ATM, BARD1, BRIP1, CDK12, CHEK1, CHEK2, FANCL, PALB2, PPP2R2A, RAD51B, RAD51C, RAD51D, and RAD54L that is predicted to be deleterious or suspected deleterious (known or predicted to be detrimental/lead to loss of function) assessed by central laboratory using validated Next-Generation Sequencing (NGS) test from blood samples.
    9. Patients have adequate organ functions, as indicated by the following laboratory values (had not received blood transfusion, apheresis infusion, erythropoietin, granulocyte colony- stimulating factor (G-CSF), and other relevant medical support within 14 days before the administration of study drug):
    a. Haemoglobin ≥9.0 g/dL.
    b. Absolute neutrophil count (ANC) ≥1.5×109/L.
    c. Platelet count ≥100×109/L.
    d. Total bilirubin (TBIL) ≤1.5×institutional upper limit of normal (ULN) (for patients with Gilbert’s syndrome, total bilirubin (TBIL) ≤3xULN is required).
    e. Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamic pyruvate transaminase [SGPT]) ≤3×institutional ULN unless liver metastases are present in which cases, they must be ≤5×ULN.
    f. Creatinine clearance ≥45 mL/min estimated using the Cockcroft-Gault equation.
    g. International normalized ratio (INR), prothrombin time (PT), and activated partial thromboplastin time (APTT) ≤1.5×ULN. It is not applicable for patients with Gilbert’s syndrome, whose enrollment should be discussed with the sponsor. The INR only applies to patients who do not receive therapeutic anti-coagulation.
    10. Planned start of first dose of study drug 2 to 8 weeks after the last dose of docetaxel.
    11. Patients have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
    12. Patients have a life expectancy of at least 16 weeks.

    For further details please refer to the protocol.
    E.4Principal exclusion criteria
    Patients who meet any of the following criteria will be excluded from the study (* is for screening part 1, all criteria for screening part 2)
    1. *Previous allogenic bone marrow transplant or double umbilical cord blood transplantation (dUCBT).
    2. *Prior treatment with a polyadenosine 5'diphosphoribose polymerisation (PARP) inhibitor, including Senaparib.
    3. *In mCRPC stage, any prior systemic therapy except for immediate prior treatment with docetaxel, NHA or necessary ADT with LHRH agonists/antagonist for mCRPC.
    4. *Patients with a known hypersensitivity to Senaparib or any of the component of Senaparib.
    5. Patients who have other new malignancies within 2 years prior to the first dose of Senaparib will be excluded, except for radically treated basal or squamous cell skin cancer. Patients with other malignancies which have been treated with no relapse within 2 years can be enrolled.
    6. Initiating bisphosphonate/denosumab therapy or adjusting bisphosphonate/denosumab dose/regimen within 28 days prior to the first dose of study drug. Patients on a stable bisphosphonate/denosumab regimen are eligible and may continue.
    7. Patients who have received chemotherapy (except for docetaxel), targeted therapy, immunotherapy, endocrine therapy (except for necessary ADT with LHRH agonists/antagonist for mCRPC), anti-tumor Chinese herbal medicine or proprietary Chinese medicine treatment or other anti-cancer systemic treatment within 5 half-lives or 28 days (whichever is longer), prior to the first dose of study drug.
    8. Patients who have any acute toxicities due to prior chemotherapy and/or radiotherapy that are >2 Grade per National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) v5.0 with the exception of alopecia.
    9. Patients who have participated in a study of an investigational agent and received study therapy or used an investigational device within 28 days of the first dose of study drug. For investigational drugs, the washout period should be 5 half-lives or 28 days whichever is longer.
    10. Patients who have received strong inhibitors/inducers of CYP3A4 which cannot be discontinued 21 days prior to the first dose of study drug and withheld throughout the study drug treatment. Patients received phenobarbital/enzalutamide will require a 5-week washout prior to the first dose of study drug.
    11. Patients who have undergone a major surgery or radical radiotherapy within 28 days prior to the first dose of study drug, or have undergone a palliative radiotherapy within 14 days prior to the first dose of study drug.
    12. *Patients with MDS or AML, or with clinical features suggestive of MDS or AML.
    13. Patients with serious acute or chronic infections.
    14. Patients who have acute myocardial infarction, unstable angina, stroke, or transient ischemic attack within 6 months prior to the first dose of study drug; patients who have congestive heart failure (New York Heart Association [NYHA] Classification Class ≥II); patients who have severe or uncontrolled hypertension, arrhythmia.
    15. Patients with known and symptomatic brain metastasis. Patients with asymptomatic, treated, stable brain metastases without steroids for at least 28 days are eligible for study entry. A radiographic imaging to confirm the absence of brain metastases is not required.
    16. Patients with symptomatic or impending spinal cord compression, unless appropriately treated for this and clinically stable and asymptomatic for 28 days prior to the first dose of study drug.
    17. Patients who are unable to swallow a whole capsule. Patients have gastrointestinal illnesses that may clinically and significantly affect the absorption of oral medication of study drug, e.g., ulcerative colitis, Crohn’s disease, chronic diarrhea with malabsorption, intractable nausea and vomiting, or have had a surgical procedure which could affect gastrointestinal absorption at discretion of investigators.
    18. Patients who have received a live virus or bacterial or RNA vaccination within 28 days prior to the first dose of study drug.
    19. Patients known to have a history of alcoholism or drug abuse within 2 years.
    20. Patients considered a high risk due to a serious, uncontrolled medical disorder, non-malignant systemic disease at discretion of investigators. Examples included but not limited to, uncontrolled grand mal seizures, hepatic sclerosis, superior vena cava syndrome, extensive interstitial bilateral lung disease or any psychiatric disorder that prohibit obtaining ICF.
    21. *Patients are unable or unwilling to abide by the study protocol or cooperate fully with the investigator or designee.
    E.5 End points
    E.5.1Primary end point(s)
    rPFS assessed by BICR in BRCA1/2+ patients
    rPFS is defined as the time from randomization to the date of first radiographic disease progression (PD) or death from any cause, whichever occurs first. Radiographic PD will be evaluated according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 and Prostate Cancer Clinical Trials Working Group 3 (PCWG3) criteria.
    E.5.1.1Timepoint(s) of evaluation of this end point
    At the time when around 96 rPFS events in BRCA1/2+ population are collected.
    DB lock planed May2024.
    E.5.2Secondary end point(s)
    Key secondary Endpoints
    rPFS assessed by BICR in HRR+ patients
    Time to pain progression in BRCA1/2+ patients
    Time to the first SSRE in BRCA1/2+ patients
    Overall survival (OS) in BRCA1/2+ patients
    Other Secondary Endpoints
    Second progression (PFS2)
    Time to PSA progression
    ORR
    PSA response rate
    Safety and PK
    Exploratory Endpiont
    Efficacy and safety of Senaparib in mCRPC patients with HRR gene
    alterations other than BRCA1/2
    E.5.2.1Timepoint(s) of evaluation of this end point
    At the time when around 96 rPFS events in BRCA1/2+ population are collected.
    DB lock planed May2024.
    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 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 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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA64
    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
    China
    Taiwan
    United States
    Belgium
    France
    Germany
    Italy
    Spain
    Switzerland
    E.8.7Trial has a data monitoring committee Yes
    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
    The end of the study is defined as the date when the last patient finished 2-year survival follow- ups, withdraws consent, being lost to follow-up, dies, or the study is terminated (whichever occurs first).
    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 months9
    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 months9
    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: 264
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 396
    F.2 Gender
    F.2.1Female No
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state115
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 484
    F.4.2.2In the whole clinical trial 660
    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)
    None
    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 Decision2021-06-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-08-24
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2022-04-20
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