Senaparib in mCRPC Patients With Homologous Recombination Repair Gene Alterations After Docetaxel Treatment
Status unconfirmed · Phase 2 · Has a placebo group
Conditions studied: mCRPC
In brief
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
Key facts
- Study ID
- NCT04822961
- Run by
- Impact Therapeutics, Inc.
- People needed
- 285
- Starts
- 2021-12-31
- Expected to finish
- 2024-08-01
- Last updated by the study team
- 2021-12-16
Who can join
Age: 18 and older. Sex: male. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Our lady of Lourdes Urology — Binghamton, New York, United States
- Princess Alexandra Hospital — Brisbane, Australia
- Cabrini Hospital — Melbourne, Australia
- Macquarie University Hospital — Sydney, Australia
- John Flynn Hospital — Tugun, Australia
- IMPACT Therapeutics Inc. — Shanghai, Shanghai Municipality, China
Full record on ClinicalTrials.gov
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