Pamiparib in mCRPC With HRD or BRCA1/2 Mutation

NCT ID: NCT05327621

Last Updated: 2022-04-14

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-01
• Study Completion Date: 2025-03-20

Brief 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.

Detailed Description

This is a single arm, open-label, single center, phase II trial, assessing the efficacy of a PARP inhibitor, Pamiparib, in 50 progressing metastatic castration-resistant prostate cancer patients with at least one line of androgen deprivation therapy or chemotherapy at the metastatic setting, and homologous recombination deficiency or BRCA 1 or 2 somatic or germline mutation.

Conditions

Metastatic Castration-resistant Prostate Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Pamiparib

Intervention Type: DRUG

40 mg bid per os , 28 day cycle, number of cycles: until progression or unacceptable toxicity develops.

Interventions

Pamiparib

40 mg bid per os , 28 day cycle, number of cycles: until progression or unacceptable toxicity develops.

Intervention Type: DRUG

Other Intervention Names

BGB-290

Eligibility Criteria

Inclusion Criteria

1. ≥18 years old, male

2. 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.

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

4. Eastern Cooperative Oncology Group (ECOG) performance status ≤1

5. BPI<4

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

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

8. 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.

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

10. Capable of swallowing the whole capsule.

11. 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.

12. Agree to sign informed consent form

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

Exclusion Criteria

1. Acute toxicity (CTCAE > grade 2) due to prior cancer therapy.

2. Received chemotherapy, endocrine therapy, biotherapy, radionuclide therapy, immunotherapy, experimental drugs, proprietary anticancer drugs or Chinese herbal medicines within 5 (if known) half-lives or 14 days(if unknown) prior to the first day of taking Pamiparib; For bisphosphonates or approved bone targeting therapy, Pamiparib must be administered at a steady dose for ≥28 days prior to the first day of taking Pamiparib.

3. Received radiation therapy within 21 days.

4. Prior treatment with any PARP inhibitor. Prior chemotherapy with mitoxantrone or platinum-based chemotherapy or cyclophosphamide. Prior treatment with sipuleucel-T or immune check point inhibitors are allowed.

5. Subjects with major surgery within 2 weeks before starting study treatment. Subjects expected to receive major surgery during the trial.

6. Active second malignancy, with the exception of curatively treated non-melanoma skin cancer, carcinoma in situ, or superficial bladder cancer

7. Symptomatic and/or untreated central nervous system metastases

8. Immunocompromised subjects, such as those with positive human immunodeficiency virus (HIV) serology.

9. Subjects with known active hepatitis (e.g. hepatitis B or C).

10. The subject has a serious cardiovascular disease. ( For example, but not limited to: uncontrolled arrhythmia, myocardial infarction)

11. Concomitant use of strong CYP3A inducers or moderate CYP3A inducers . If half-lives is known, a 5 half-lives washout period is required before the start of Pamiparib therapy and a 2-week washout period is required when the half-lives is unknown.

12. History of intolerance to Pamiparib capsule excipients

13. Excluded by investigators

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Sun Yat-sen University

OTHER

Sponsor Role: lead

Responsible Party

ZHOU FANGJIAN

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Fangjian Zhou, M.D.

Role: PRINCIPAL_INVESTIGATOR

Sun Yat-sen University

Locations

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

Site Status: RECRUITING

Countries

China

Central Contacts

Fangjian Zhou, M.D.

Role: CONTACT

zhoufj@sysucc.org.cn

020-87343656

Yonghong Li, M.D.

Role: CONTACT

liyongh@sysucc.org.cn

020-87343656

Facility Contacts

Fangjian Zhou, M.D.

Role: primary

zhoufj@sysucc.org.cn

020-87343656

Yonghong Li, M.D.

Role: backup

liyongh@sysucc.org.cn

020-87343656

Other Identifiers

2021-FXY-385

Identifier Type: -

Identifier Source: org_study_id