Trial purpose
Cancer treatment
Tumor type
Genitourinary
Age
18+
Clinical summary
Summary
Eligible participants will be randomised to receive either Senaparib tablets or a placebo comparator.
Conditions
This trial is treating people with metastatic castration-resistant prostate cancer Homologous Recombination Repair Gene Alterations
Eligibility
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.
Inclusion
- Your cancer has spread to other parts of the body (metastatic) or has grown into nearby parts of the body (locally advanced).
- You are able to swallow medication by mouth.
- You have had a certain type of treatment or surgical procedure.
Exclusion
- You have been diagnosed with a prior or secondary type of cancer.
- You have certain types of non-cancer medical conditions.
- You have had certain treatments, surgical procedures or drugs.
Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.
More information
Trial Identifiers
Information on this page is partially produced from ClinicalTrials.gov *. View further details about this trial on the registry via the links below:
Trial sponsor
Impact Therapeutics, Inc.
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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