Pamiparib in mCRPC With HRD or BRCA1/2 Mutation

  • STATUS
    Recruiting
  • End date
    Mar 20, 2025
  • participants needed
    50
  • sponsor
    Sun Yat-sen University
Updated on 30 April 2022

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.

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.

Details
Condition Metastatic Castration-resistant Prostate Cancer
Treatment pamiparib
Clinical Study IdentifierNCT05327621
SponsorSun Yat-sen University
Last Modified on30 April 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

≥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 ≥
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

Exclusion Criteria

Subjects should not enter the study if any of the following exclusion criteria are
fulfilled
Acute toxicity (CTCAE > grade 2) due to prior cancer therapy
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
Received radiation therapy within 21 days
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
Subjects with major surgery within 2 weeks before starting study treatment. Subjects
expected to receive major surgery during the trial
Active second malignancy, with the exception of curatively treated non-melanoma skin
cancer, carcinoma in situ, or superficial bladder cancer
Symptomatic and/or untreated central nervous system metastases
Immunocompromised subjects, such as those with positive human immunodeficiency virus
(HIV) serology
Subjects with known active hepatitis (e.g. hepatitis B or C)
The subject has a serious cardiovascular disease. ( For example, but not limited to
uncontrolled arrhythmia, myocardial infarction)
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
History of intolerance to Pamiparib capsule excipients
Excluded by investigators
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