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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
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
Secondary ID [1] 0 0
IMP4297-202
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
mCRPC 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
rPFS assessed by BICR
Timepoint [1] 0 0
80 weeks
Secondary outcome [1] 0 0
rPFS assessed by BICR
Timepoint [1] 0 0
80 weeks
Secondary outcome [2] 0 0
Time to pain progression
Timepoint [2] 0 0
80 weeks
Secondary outcome [3] 0 0
Time from randomization to the first SSRE
Timepoint [3] 0 0
80 weeks
Secondary outcome [4] 0 0
OS
Timepoint [4] 0 0
80 weeks
Secondary outcome [5] 0 0
PFS2
Timepoint [5] 0 0
80 weeks
Secondary outcome [6] 0 0
Time to pain progression
Timepoint [6] 0 0
80 weeks
Secondary outcome [7] 0 0
Time from randomization to the first SSRE
Timepoint [7] 0 0
80 weeks
Secondary outcome [8] 0 0
OS
Timepoint [8] 0 0
80 weeks
Secondary outcome [9] 0 0
rPFS assessed by the investigator
Timepoint [9] 0 0
80 weeks
Secondary outcome [10] 0 0
Time to PSA progression
Timepoint [10] 0 0
80 weeks
Secondary outcome [11] 0 0
Objective response rate (ORR) according to RECIST v1.1 assessed by BICR
Timepoint [11] 0 0
80 weeks
Secondary outcome [12] 0 0
Objective response rate (ORR) according to RECIST v1.1 assessed by investigator
Timepoint [12] 0 0
80 weeks
Secondary outcome [13] 0 0
PSA response rate according to PCWG3 criteria assessed by central laboratory
Timepoint [13] 0 0
80 weeks
Secondary outcome [14] 0 0
Safety endpoints
Timepoint [14] 0 0
80 weeks
Secondary outcome [15] 0 0
Cmax
Timepoint [15] 0 0
80 weeks

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.
Minimum age
18 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
No
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
UNKNOWN
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
31/12/2021
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/08/2024
Actual
Sample size
Target
285
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Princess Alexandra Hospital - Brisbane
Recruitment hospital [2] 0 0
Cabrini Hospital - Melbourne
Recruitment hospital [3] 0 0
Macquarie University Hospital - Sydney
Recruitment hospital [4] 0 0
John Flynn Hospital - Tugun
Recruitment postcode(s) [1] 0 0
- Brisbane
Recruitment postcode(s) [2] 0 0
- Melbourne
Recruitment postcode(s) [3] 0 0
- Sydney
Recruitment postcode(s) [4] 0 0
- Tugun
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
New York
Country [2] 0 0
China
State/province [2] 0 0
Shanghai

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Impact Therapeutics, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
xingxing Zhang
Address 0 0
Country 0 0
Phone 0 0
+862168411121
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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