mCRPCPhase 2NCT04822961
Senaparib in mCRPC Patients With Homologous Recombination Repair Gene Alterations After Docetaxel Treatment
A Phase 2 study testing Senaparib in people with mCRPC, run by Impact Therapeutics, Inc. at 6 sites in 3 countries.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- mCRPC
- What is being tested?
- Senaparib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 285 participants
- Where
- 6 sitesin 3 countries
- Study dates
- 31 Dec 2021to Aug 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must voluntarily participate in this clinical study. Be willing written informed consent form (ICF) prior to any study activity.
- Male ≥18 years of age on the day of signing the ICF.
- Patients must have histologically or cytologically confirmed prostate adenocarcinoma.
- 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.
- 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).
- Patients have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
- 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.
Who cannot join
- Previous allogenic bone marrow transplant or double umbilical cord blood transplantation (dUCBT).
- Prior treatment with a polyadenosine 5'diphosphoribose polymerisation (PARP) inhibitor, including Senaparib.
- Patients with a known hypersensitivity to Senaparib or any of the component of Senaparib.
- 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.
- 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.
- Patients with MDS or AML, or with clinical features suggestive of MDS or AML.
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- Patients with serious acute or chronic infections.
- Patients who have received a live virus or bacterial or RNA vaccination within 28 days prior to the first dose of study drug.
- Patients are unable or unwilling to abide by the study protocol or cooperate fully with the investigator or designee.
Trial locations and contacts
6 sites in 3 countries.
6 sites in 3 countries
Australia4 sites
Princess Alexandra Hospital
Brisbane
Elizabeth McCaffrey, Dr, +61 7 3176 7237, pah-ctu-medonctrials@health.qld.gov.au
Cabrini Hospital
Melbourne
Macquarie University Hospital
Sydney
Howard Gurney, Prof., +61 2 9812 2956, clinicaltrials@mq.edu.au
John Flynn Hospital
Tugun
United States1 site
Our lady of Lourdes Urology
Binghamton, New York, 13905
Cynthia Campo, 607-729-7666, cynthia.campo@ascension.org
Genevieve Romano-Helm, 607-729-7666, genevieve.romanohelm@ascension.org
About this study
Official 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
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
Read the detailed description
This is a randomized, double-blinded, placebo-controlled, multicenter, Phase II study in mCRPC patients with HRR gene alterations after docetaxel therapy to evaluate the anti-tumor activity and safety of Senaparib.
- Conditions
- mCRPC
- Being tested
- Placebo, Senaparib
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Senaparib-matched placebo capsules
SenaparibDrug
20 mg capsules
| Study group | Role | What they receive |
|---|---|---|
| Senaparib (IMP4297) 20 mg | Experimental | 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 Receives: Drug: Placebo |
| Placebo | Placebo comparator | During the treatment period, eligible patients will receive placebo QD, continuously on a 4-week cycle Receives: Drug: Senaparib |
What is being measured
The primary outcome is the main question the study is designed to answer.
rPFS assessed by BICR
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).
Measured: 80 weeks
Secondary outcomes (15)
rPFS assessed by BICR
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.
Measured: 80 weeks
Time to pain progression
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.
Measured: 80 weeks
Time from randomization to the first SSRE
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.
Measured: 80 weeks
OS
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.
Measured: 80 weeks
PFS2
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.
Measured: 80 weeks
Time to pain progression
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.
Measured: 80 weeks
Time from randomization to the first SSRE
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.
Measured: 80 weeks
OS
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.
Measured: 80 weeks
rPFS assessed by the investigator
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.
Measured: 80 weeks
Time to PSA progression
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.
Measured: 80 weeks
Objective response rate (ORR) according to RECIST v1.1 assessed by BICR
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.
Measured: 80 weeks
Objective response rate (ORR) according to RECIST v1.1 assessed by investigator
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.
Measured: 80 weeks
PSA response rate according to PCWG3 criteria assessed by central laboratory
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.
Measured: 80 weeks
Safety endpoints
Number of participants with treatment-related adverse events as assessed by NCI CTCAE v5.0.
Measured: 80 weeks
Cmax
Maximum plasma concentration，To characterize the plasma PK profile of Senaparib via population PK (popPK) modeling
Measured: 80 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2021
- Study start31 Dec 2021 (estimated)
- Primary completionMay 2024 (estimated)
- Study completionAug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for mCRPCStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, Double-Blinded, Placebo-Controlled
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 285 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Impact Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04822961
- Sponsor's protocol ID
- IMP4297-202
- Status last verified
- Dec 2021
- First submitted
- 3 Sep 2020
- Last updated
- 16 Dec 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT04822961
- Acronym / sponsor ID
- IMP4297-202
- Conditions
- mCRPC
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 285 participants (estimated)
- Lead sponsor
- Impact Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 31 Dec 2021 (estimated)
- Primary completion
- May 2024 (estimated)
- Study completion
- Aug 2024 (estimated)
- First posted
- 30 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
This is a randomized, double-blinded, placebo-controlled, multicenter, Phase II study in mCRPC patients with HRR gene alterations after docetaxel therapy to evaluate the anti-tumor activity and safety of Senaparib.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Randomized, Double-Blinded, Placebo-Controlled
| Arm | Type | Receives |
|---|---|---|
| Senaparib (IMP4297) 20 mg | Experimental | Drug: PlaceboDuring 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 | Placebo comparator | Drug: SenaparibDuring the treatment period, eligible patients will receive placebo QD, continuously on a 4-week cycle |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients must voluntarily participate in this clinical study. Be willing written informed consent form (ICF) prior to any study activity.
- Male ≥18 years of age on the day of signing the ICF.
- Patients must have histologically or cytologically confirmed prostate adenocarcinoma.
- 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.
- 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).
Key exclusion criteria (9 listed)
- Previous allogenic bone marrow transplant or double umbilical cord blood transplantation (dUCBT).
- Prior treatment with a polyadenosine 5'diphosphoribose polymerisation (PARP) inhibitor, including Senaparib.
- Patients with a known hypersensitivity to Senaparib or any of the component of Senaparib.
- 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.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlaceboSenaparib-matched placebo capsules | Drug | Senaparib (IMP4297) 20 mg |
| Senaparib20 mg capsules | Drug | Placebo |
Primary outcome
rPFS assessed by BICR
Time frame: 80 weeks
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).
15 secondary outcomes
rPFS assessed by BICR
Time frame: 80 weeks
Time to pain progression
Time frame: 80 weeks
Time from randomization to the first SSRE
Time frame: 80 weeks
OS
Time frame: 80 weeks
PFS2
Time frame: 80 weeks
Time to pain progression
Time frame: 80 weeks
Time from randomization to the first SSRE
Time frame: 80 weeks
OS
Time frame: 80 weeks
rPFS assessed by the investigator
Time frame: 80 weeks
Time to PSA progression
Time frame: 80 weeks
Objective response rate (ORR) according to RECIST v1.1 assessed by BICR
Time frame: 80 weeks
Objective response rate (ORR) according to RECIST v1.1 assessed by investigator
Time frame: 80 weeks
PSA response rate according to PCWG3 criteria assessed by central laboratory
Time frame: 80 weeks
Safety endpoints
Time frame: 80 weeks
Cmax
Time frame: 80 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2021.
- Individual participant dataSharing planned: No
Related trials for mCRPC
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
RecruitingObservational study
ARCTIC: Liquid Biomarkers in the Prospective Androgen Receptor Signaling Inhibitors (ARSI) Resistance Clinical Trials
Prostate Cancer, Prostate Adenocarcinoma
Active, not recruitingPhase 2
FPI-2265 (225Ac-PSMA-I&T) and Olaparib for Patients With Metastatic Castration-Resistant Prostate Cancer (mCRPC)
Metastatic Castration-resistant Prostate Cancer
Active, not recruitingPhase 3
Talazoparib + Enzalutamide vs. Enzalutamide Monotherapy in mCRPC
mCRPC
RecruitingPhase 3
Study of Opevesostat (MK-5684) Versus Alternative NHA in mCRPC (MK-5684-003)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
6 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Senaparib in people with mCRPC, run by Impact Therapeutics, Inc. at 6 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Australia, United States, China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact xingxing Zhang (+862168411121, xingxing.zhang@impacttherapeutics.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
rPFS assessed by BICR (time frame: 80 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2021.