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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT04822961
Registration number
NCT04822961
Ethics application status
Date submitted
3/09/2020
Date registered
30/03/2021
Titles & IDs
Public title
Senaparib in mCRPC Patients With Homologous Recombination Repair Gene Alterations After Docetaxel Treatment
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Scientific title
A Randomized, Double-Blinded, Placebo-Controlled, Multicenter, Phase II Study to Evaluate Senaparib in mCRPC Patients With Homologous Recombination Repair Gene Alterations After Docetaxel Treatment
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Secondary ID [1]
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IMP4297-202
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
mCRPC
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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Placebo
Treatment: Drugs - Senaparib
Experimental: Senaparib (IMP4297) 20 mg - During the treatment period, eligible patients will receive single agent of Senaparib at a dose of 100 mg once daily (QD), continuously on a 4-week cycle
Placebo comparator: Placebo - During the treatment period, eligible patients will receive placebo QD, continuously on a 4-week cycle
Treatment: Drugs: Placebo
Senaparib-matched placebo capsules
Treatment: Drugs: Senaparib
20 mg capsules
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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rPFS assessed by BICR
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Assessment method [1]
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To evaluate the impact of Senaparib on radiographic progression free survival (rPFS), compared with the placebo, in metastatic castration-resistant prostate cancer (mCRPC) patients with BRCA1/2 gene alteration who have not progressed after docetaxel therapy assessed by Blinded Independent Central Review (BICR).
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Timepoint [1]
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80 weeks
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Secondary outcome [1]
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rPFS assessed by BICR
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Assessment method [1]
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To evaluate the impact of Senaparib on rPFS, compared with the placebo, in mCRPC patients with homologous recombination repair (HRR) gene alterations who have not progressed after docetaxel therapy assessed by BICR.
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Timepoint [1]
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80 weeks
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Secondary outcome [2]
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Time to pain progression
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Assessment method [2]
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To evaluate the impact of Senaparib on time to pain progression, compared with the placebo, in mCRPC patients with BRCA1/2 gene alteration who have not progressed after docetaxel therapy.
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Timepoint [2]
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80 weeks
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Secondary outcome [3]
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Time from randomization to the first SSRE
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Assessment method [3]
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To evaluate the impact of Senaparib on time to the first symptomatic skeletal related events (SSRE), compared with the placebo, in mCRPC patients with BRCA1/2 gene alteration who have not progressed after docetaxel therapy.
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Timepoint [3]
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80 weeks
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Secondary outcome [4]
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OS
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Assessment method [4]
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To evaluate the impact of Senaparib on overall survival (OS), compared with the placebo, in mCRPC patients with BRCA1/2 gene alteration who have not progressed after docetaxel therapy.
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Timepoint [4]
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80 weeks
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Secondary outcome [5]
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PFS2
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Assessment method [5]
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To evaluate the impact of Senaparib on second progression (PFS2), compared with the placebo, in mCRPC patients with BRCA1/2 gene alteration and HRR gene alterations who have not progressed after docetaxel therapy.
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Timepoint [5]
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80 weeks
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Secondary outcome [6]
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Time to pain progression
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Assessment method [6]
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To evaluate the impact of Senaparib on time to pain progression, compared with the placebo, in mCRPC patients with HRR gene alterations who have not progressed after docetaxel therapy.
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Timepoint [6]
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80 weeks
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Secondary outcome [7]
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Time from randomization to the first SSRE
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Assessment method [7]
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To evaluate the impact of Senaparib on time to the first SSRE, compared with the placebo, in mCRPC patients with HRR gene alterations who have not progressed after docetaxel therapy.
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Timepoint [7]
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80 weeks
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Secondary outcome [8]
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OS
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Assessment method [8]
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To evaluate the impact of Senaparib on OS, compared with the placebo, in mCRPC patients with HRR gene alterations who have not progressed after docetaxel therapy.
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Timepoint [8]
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80 weeks
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Secondary outcome [9]
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rPFS assessed by the investigator
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Assessment method [9]
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To evaluate the impact of Senaparib on rPFS assessed by the investigator, compared with the placebo, in mCRPC patients with BRCA1/2 gene alteration and HRR gene alterations who have not progressed after docetaxel therapy.
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Timepoint [9]
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80 weeks
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Secondary outcome [10]
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Time to PSA progression
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Assessment method [10]
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To evaluate the impact of Senaparib on time to prostate-specific antigen (PSA) progression, compared with the placebo, in mCRPC patients with BRCA1/2 gene alteration and HRR gene alterations who have not progressed after docetaxel therapy.
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Timepoint [10]
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80 weeks
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Secondary outcome [11]
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Objective response rate (ORR) according to RECIST v1.1 assessed by BICR
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Assessment method [11]
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To evaluate the impact of Senaparib on radiographic response rate assessed by BICR, compared with the placebo, in mCRPC patients with BRCA1/2 gene alteration and HRR gene alterations who have measurable lesion and have not progressed after docetaxel therapy.
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Timepoint [11]
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80 weeks
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Secondary outcome [12]
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Objective response rate (ORR) according to RECIST v1.1 assessed by investigator
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Assessment method [12]
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To evaluate the impact of Senaparib on radiographic response rate assessed by the investigator, compared with the placebo, in mCRPC patients with BRCA1/2 gene alteration and HRR gene alterations who have measurable lesion and have not progressed after docetaxel therapy.
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Timepoint [12]
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80 weeks
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Secondary outcome [13]
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PSA response rate according to PCWG3 criteria assessed by central laboratory
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Assessment method [13]
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To evaluate the impact of Senaparib on PSA response rate, compared with the placebo, in mCRPC patients with BRCA1/2 gene alteration and HRR gene alterations who have not progressed after docetaxel therapy.
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Timepoint [13]
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80 weeks
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Secondary outcome [14]
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Safety endpoints
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Assessment method [14]
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Number of participants with treatment-related adverse events as assessed by NCI CTCAE v5.0.
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Timepoint [14]
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80 weeks
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Secondary outcome [15]
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Cmax
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Assessment method [15]
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Maximum plasma concentration,To characterize the plasma PK profile of Senaparib via population PK (popPK) modeling
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Timepoint [15]
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80 weeks
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Eligibility
Key inclusion criteria
1. Patients must voluntarily participate in this clinical study. Be willing 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. 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.
5. 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).
6. Patients have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
7. Male patients must use a condom during treatment and for 3 months after the last dose of study drug when having sexual intercourse with a woman of childbearing potential. Female partners of male patients should also use an acceptable method of contraception if they are of childbearing potential.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Males
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Can healthy volunteers participate?
No
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Key exclusion criteria
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. Patients with a known hypersensitivity to Senaparib or any of the component of Senaparib.
4. 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.
5. 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.
6. Patients with MDS or AML, or with clinical features suggestive of MDS or AML.
7. Patients with serious acute or chronic infections.
8. Patients who have received a live virus or bacterial or RNA vaccination within 28 days prior to the first dose of study drug.
9. Patients are unable or unwilling to abide by the study protocol or cooperate fully with the investigator or designee.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
UNKNOWN
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
31/12/2021
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Actual
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/08/2024
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Actual
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Sample size
Target
285
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Princess Alexandra Hospital - Brisbane
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Recruitment hospital [2]
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Cabrini Hospital - Melbourne
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Recruitment hospital [3]
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Macquarie University Hospital - Sydney
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Recruitment hospital [4]
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John Flynn Hospital - Tugun
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Recruitment postcode(s) [1]
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- Brisbane
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Recruitment postcode(s) [2]
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- Melbourne
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Recruitment postcode(s) [3]
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- Sydney
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Recruitment postcode(s) [4]
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- Tugun
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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New York
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Country [2]
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China
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State/province [2]
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Shanghai
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Impact Therapeutics, Inc.
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
The purpose of this study is to evaluate the efficacy and safety of Senaparib in metastatic castration-resistant prostate cancer (mCRPC) patients with homologous recombination repair (HRR) gene alterations after docetaxel treatment
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Trial website
https://clinicaltrials.gov/study/NCT04822961
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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xingxing Zhang
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Address
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Country
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Phone
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+862168411121
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT04822961