Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT04822961
Registration number
NCT04822961
Ethics application status
Date submitted
3/09/2020
Date registered
30/03/2021
Date last updated
16/12/2021
Titles & IDs
Public title
Senaparib in mCRPC Patients With Homologous Recombination Repair Gene Alterations After Docetaxel Treatment
Query!
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
Query!
Secondary ID [1]
0
0
IMP4297-202
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
mCRPC
0
0
Query!
Condition category
Condition code
Intervention/exposure
Study type
Interventional
Query!
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
Query!
Intervention code [1]
0
0
Treatment: Drugs
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
rPFS assessed by BICR
Query!
Assessment method [1]
0
0
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).
Query!
Timepoint [1]
0
0
80 weeks
Query!
Secondary outcome [1]
0
0
rPFS assessed by BICR
Query!
Assessment method [1]
0
0
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.
Query!
Timepoint [1]
0
0
80 weeks
Query!
Secondary outcome [2]
0
0
Time to pain progression
Query!
Assessment method [2]
0
0
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.
Query!
Timepoint [2]
0
0
80 weeks
Query!
Secondary outcome [3]
0
0
Time from randomization to the first SSRE
Query!
Assessment method [3]
0
0
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.
Query!
Timepoint [3]
0
0
80 weeks
Query!
Secondary outcome [4]
0
0
OS
Query!
Assessment method [4]
0
0
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.
Query!
Timepoint [4]
0
0
80 weeks
Query!
Secondary outcome [5]
0
0
PFS2
Query!
Assessment method [5]
0
0
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.
Query!
Timepoint [5]
0
0
80 weeks
Query!
Secondary outcome [6]
0
0
Time to pain progression
Query!
Assessment method [6]
0
0
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.
Query!
Timepoint [6]
0
0
80 weeks
Query!
Secondary outcome [7]
0
0
Time from randomization to the first SSRE
Query!
Assessment method [7]
0
0
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.
Query!
Timepoint [7]
0
0
80 weeks
Query!
Secondary outcome [8]
0
0
OS
Query!
Assessment method [8]
0
0
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.
Query!
Timepoint [8]
0
0
80 weeks
Query!
Secondary outcome [9]
0
0
rPFS assessed by the investigator
Query!
Assessment method [9]
0
0
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.
Query!
Timepoint [9]
0
0
80 weeks
Query!
Secondary outcome [10]
0
0
Time to PSA progression
Query!
Assessment method [10]
0
0
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.
Query!
Timepoint [10]
0
0
80 weeks
Query!
Secondary outcome [11]
0
0
Objective response rate (ORR) according to RECIST v1.1 assessed by BICR
Query!
Assessment method [11]
0
0
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.
Query!
Timepoint [11]
0
0
80 weeks
Query!
Secondary outcome [12]
0
0
Objective response rate (ORR) according to RECIST v1.1 assessed by investigator
Query!
Assessment method [12]
0
0
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.
Query!
Timepoint [12]
0
0
80 weeks
Query!
Secondary outcome [13]
0
0
PSA response rate according to PCWG3 criteria assessed by central laboratory
Query!
Assessment method [13]
0
0
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.
Query!
Timepoint [13]
0
0
80 weeks
Query!
Secondary outcome [14]
0
0
Safety endpoints
Query!
Assessment method [14]
0
0
Number of participants with treatment-related adverse events as assessed by NCI CTCAE v5.0.
Query!
Timepoint [14]
0
0
80 weeks
Query!
Secondary outcome [15]
0
0
Cmax
Query!
Assessment method [15]
0
0
Maximum plasma concentration,To characterize the plasma PK profile of Senaparib via population PK (popPK) modeling
Query!
Timepoint [15]
0
0
80 weeks
Query!
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.
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Males
Query!
Can healthy volunteers participate?
No
Query!
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.
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Blinded (masking used)
Query!
Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 2
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Not yet recruiting
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
31/12/2021
Query!
Actual
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
1/08/2024
Query!
Actual
Query!
Sample size
Target
285
Query!
Accrual to date
Query!
Final
Query!
Recruitment in Australia
Recruitment state(s)
Query!
Recruitment hospital [1]
0
0
Princess Alexandra Hospital - Brisbane
Query!
Recruitment hospital [2]
0
0
Cabrini Hospital - Melbourne
Query!
Recruitment hospital [3]
0
0
Macquarie University Hospital - Sydney
Query!
Recruitment hospital [4]
0
0
John Flynn Hospital - Tugun
Query!
Recruitment postcode(s) [1]
0
0
- Brisbane
Query!
Recruitment postcode(s) [2]
0
0
- Melbourne
Query!
Recruitment postcode(s) [3]
0
0
- Sydney
Query!
Recruitment postcode(s) [4]
0
0
- Tugun
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
New York
Query!
Country [2]
0
0
China
Query!
State/province [2]
0
0
Shanghai
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Query!
Name
Impact Therapeutics, Inc.
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
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
Query!
Trial website
https://clinicaltrials.gov/ct2/show/NCT04822961
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
xingxing Zhang
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
+862168411121
Query!
Fax
0
0
Query!
Email
0
0
[email protected]
Query!
Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT04822961
Download to PDF