A Single Arm, Open-label, Phase II Study to Assess the Efficacy of Pamiparib in Metastatic Castration-Resistant Prostate Cancer Patients With Homologous Recombination Deficiency (HRD) or BRCA1/2 Mutation

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

The purpose of this study is to assess the efficacy of a PARP inhibitor, Pamiparib, in metastatic castration-resistant prostate cancer patients with homologous recombination deficiency or BRCA 1 or 2 somatic/germline mutation.

Eligibility
Participation Requirements
Sex: Male
Minimum Age: 18
Healthy Volunteers: No
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• ≥18 years old, male

• Have a histologically or cytologically confirmed adenocarcinoma or poorly differentiated carcinoma without neuroendocrine differentiation of the prostate. Mixed histology is accepted, except for small cell carcinoma.

• Have a deleterious mutation in BRCA1/2 , or HRD score ≥ 9.

• Eastern Cooperative Oncology Group (ECOG) performance status ≤1

• BPI<4

• Metastatic Castration-resistant Prostate Cancer (mCRPC): Presence of measurable target lesion according to RECIST criteria v1.1

• Male subject has been surgically or medically sterilized and has serum testosterone level ≤1.73nmol/L.

• Unsterilized male subject uses an acceptable method of contraception (defined as a barrier method with spermicide) to prevent pregnancy during the duration of the study and for 6 months after the last dose of Pamiparib.

• Experienced disease progression after having received at least 1 prior next-generation androgen receptor-targeted therapies, for metastatic castration-resistant disease.

• Capable of swallowing the whole capsule.

• Subjects must have normal organ and bone marrow function at baseline, as defined below:

• Hemoglobin ≥ 9.0 g/dL at least 28 days after transfusion . Absolute neutrophil count ≥ 1.5 × 10^9/L. Platelet count ≥ 100 × 10^9/L. Total bilirubin ≤ 1.5 × the upper limit of normal (ULN) specified. Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase/alanine aminotransferase (ALT) serum glutamic pyruvic transaminase) ≤ 3 × the specified ULN, unless liver metastases are present, in which case it must be ≤ 5 × ULN.

• Agree to sign informed consent form

• Agree not to participate in other interventional trials during this trial.

Locations
Other Locations
China
Sun Yat-sen University Cancer Center
Recruiting
Guangzhou
Contact Information
Primary
Fangjian Zhou, M.D.
zhoufj@sysucc.org.cn
020-87343656
Backup
Yonghong Li, M.D.
liyongh@sysucc.org.cn
020-87343656
Time Frame
Start Date: May 1, 2022
Estimated Completion Date: March 20, 2025
Participants
Target number of participants: 50
Treatments
Experimental: Pamiparib
Tablets 20mg per os : 40 mg / bid every day in continuous. Patients will be treated with Pamiparib. Cycles are defined in 28-day periods. Disease response will be assessed every 8 weeks (RECIST 1.1). Safety will be assessed continuously.
Related Therapeutic Areas
Sponsors
Leads: Sun Yat-sen University

This content was sourced from clinicaltrials.gov

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