Status:
UNKNOWN
Senaparib in mCRPC Patients With Homologous Recombination Repair Gene Alterations After Docetaxel Treatment
Lead Sponsor:
Impact Therapeutics, Inc.
Conditions:
mCRPC
Eligibility:
MALE
18+ years
Phase:
PHASE2
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 altera...
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...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
- 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.
Key Trial Info
Start Date :
December 31 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2024
Estimated Enrollment :
285 Patients enrolled
Trial Details
Trial ID
NCT04822961
Start Date
December 31 2021
End Date
August 1 2024
Last Update
December 16 2021
Active Locations (6)
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1
Our lady of Lourdes Urology
Binghamton, New York, United States, 13905
2
Princess Alexandra Hospital
Brisbane, Australia
3
Cabrini Hospital
Melbourne, Australia
4
Macquarie University Hospital
Sydney, Australia