Senaparib in mCRPC Patients With Homologous Recombination Repair Gene Alterations After Docetaxel Treatment
NCT ID: NCT04822961
Last Updated: 2021-12-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
285 participants
INTERVENTIONAL
2021-12-31
2024-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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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
Senaparib-matched placebo capsules
Placebo
During the treatment period, eligible patients will receive placebo QD, continuously on a 4-week cycle
Senaparib
20 mg capsules
Interventions
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Placebo
Senaparib-matched placebo capsules
Senaparib
20 mg capsules
Eligibility Criteria
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Inclusion Criteria
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.
Exclusion Criteria
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.
18 Years
MALE
No
Sponsors
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Impact Therapeutics, Inc.
INDUSTRY
Responsible Party
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Locations
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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
Countries
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Central Contacts
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Facility Contacts
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Cynthia Campo
Role: primary
Genevieve Romano-Helm
Role: backup
Elizabeth McCaffrey, Dr
Role: primary
Howard Gurney, Prof.
Role: primary
Other Identifiers
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IMP4297-202
Identifier Type: -
Identifier Source: org_study_id