Senaparib in mCRPC Patients With Homologous Recombination Repair Gene Alterations After Docetaxel Treatment

NCT04822961 | Unknown Phase 2 DMC

• 1 other identifier: IMP4297-202
• Study Type: interventional
• Target: 285
• Locations: 3 countries
• Sites: 6

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 alterations after docetaxel treatment

Conditions

mCRPC

Outcome Measures

Primary Outcomes (1)

• 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).

  80 weeks

Secondary Outcomes (15)

• rPFS assessed by BICR

  80 weeks

• Time to pain progression

  80 weeks

• Time from randomization to the first SSRE

  80 weeks

• OS

  80 weeks

• PFS2

  80 weeks

Study Arms (2)

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

Drug: Placebo

Placebo

PLACEBO COMPARATOR

During the treatment period, eligible patients will receive placebo QD, continuously on a 4-week cycle

Drug: Senaparib

Interventions

Placebo DRUG

Senaparib-matched placebo capsules

Senaparib (IMP4297) 20 mg

Senaparib DRUG

20 mg capsules

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Impact Therapeutics, Inc.: lead

Study Sites (6)

Our lady of Lourdes Urology

Binghamton, New York, 13905, United States

Location

Princess Alexandra Hospital

Brisbane, Australia

Location

Cabrini Hospital

Melbourne, Australia

Location

Macquarie University Hospital

Sydney, Australia

Location

John Flynn Hospital

Tugun, Australia

Location

IMPACT Therapeutics Inc.

Shanghai, Shanghai Municipality, China

Location

MeSH Terms

Interventions

senaparib

Central Study Contacts

xingxing Zhang

CONTACT

+862168411121; xingxing.zhang@impacttherapeutics.com

Yafei Liu

CONTACT

+8613354072796; lyf@impacttherapeutics.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomized, Double-Blinded, Placebo-Controlled

Study Record Dates

• First Submitted: September 3, 2020
• First Posted: March 30, 2021
• Study Start: December 31, 2021
• Primary Completion: May 1, 2024
• Study Completion: August 1, 2024
• Last Updated: December 16, 2021

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1); AU (4); CN (1)