Metastatic Castration-resistant Prostate Cancer Clinical Trial
Official title:
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
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.
Status | Recruiting |
Enrollment | 50 |
Est. completion date | March 20, 2025 |
Est. primary completion date | March 20, 2025 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 18 Years and older |
Eligibility | 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: Subjects should not enter the study if any of the following exclusion criteria are fulfilled: 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 |
Country | Name | City | State |
---|---|---|---|
China | Sun Yat-sen University Cancer Center | Guangzhou | Guangdong |
Lead Sponsor | Collaborator |
---|---|
Sun Yat-sen University |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | rPFS stratified by baseline HRD score (HRD score threshold is defined as 9) | The rPFS is defined as the duration from Pamiparib initiation to radiologic disease progression or death from any cause, whichever comes first. | 3 years | |
Other | OS stratified by baseline HRD score (HRD score threshold is defined as 9) | The OS is defined as the duration from Pamiparib initiation to any death. | 3 years | |
Primary | Radiologic Progression-free Survival (rPFS) | Radiologic progression-free survival will be assessed from the time of the first dose to radiologic disease progression or death from any cause, whichever comes first. | 3 years | |
Secondary | Objective Response Rate (ORR) | Proportion of patients in complete remission (CR) plus partial remission (PR) | From enrollment to primary completion of study (up to approximately 3 years) | |
Secondary | Duration of Response (DOR) | Time from the start of the first assessment of the tumor as CR or PR to the first assessment of PD (Progressive Disease) or death from any cause. | From enrollment to primary completion of study (up to approximately 3 years) | |
Secondary | Time to Response (TTR) | Time from initiation of treatment to first assessment of tumor as CR or PR. | From enrollment to primary completion of study (up to approximately 3 years) | |
Secondary | Clinical Benefit Rate | according to RECIST, is either complete response (CR), partial response (PR) or stable disease (SD) lasting for at least 16 weeks | 3 years | |
Secondary | Prostate Specific Antigen (PSA) Response Rate | Proportion of patients with a 50% decrease in PSA from baseline | From enrollment to primary completion of study (up to approximately 3 years) | |
Secondary | Time to PSA Progression | Time from initiation of treatment to two consecutive 50% PSA increases from baseline level | From enrollment to primary completion of study (up to approximately 3 years) | |
Secondary | Overall Survival (OS) | Time between the start of treatment and death from any cause | From enrollment to primary completion of study (up to approximately 3 years) | |
Secondary | Adverse events | Adverse events are graded according to the CTCAE V4.03 | 3 years |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT04986423 -
ZEN003694 and Enzalutamide Versus Enzalutamide Monotherapy in Metastatic Castration-Resistant Prostate Cancer
|
Phase 2 | |
Recruiting |
NCT05489211 -
Study of Dato-Dxd as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Tumours (TROPION-PanTumor03)
|
Phase 2 | |
Terminated |
NCT05489991 -
A Study of TmPSMA-02 Chimeric Antigen Receptor (CAR) T-cells in Patients With Metastatic Castration Resistant Prostate Cancer (mCRPC)
|
Phase 1/Phase 2 | |
Active, not recruiting |
NCT05521412 -
EValuation of radIOLigand Treatment in mEn With Metastatic Castration-resistant Prostate Cancer With [161Tb]Tb-PSMA-I&T
|
Phase 1/Phase 2 | |
Terminated |
NCT04556617 -
PLX2853 in Combination With Abiraterone Acetate and Prednisone and in Combination With Olaparib in Subjects With Metastatic Castration-Resistant Prostate Cancer (mCRPC)
|
Phase 1/Phase 2 | |
Completed |
NCT02125357 -
Sequencing Abiraterone and Enzalutamide in mCRPC
|
Phase 2 | |
Recruiting |
NCT06052306 -
A Study to Learn How Safe the Study Treatment Actinium-225-macropa-pelgifatamab (BAY3546828) is, How it Affects the Body, How it Moves Into, Through and Out of the Body, and About Its Anticancer Activity in Men With Advanced Metastatic Castration-resistant Prostate Cancer (mCRPC)
|
Phase 1 | |
Recruiting |
NCT05917470 -
A Clinical Study of ONCT-534 in Subjects With Metastatic Castration-resistant Prostate Cancer.
|
Phase 1/Phase 2 | |
Recruiting |
NCT05519449 -
Study of JANX007 in Subjects With Metastatic Castration-Resistant Prostate Cancer (ENGAGER-PSMA-01)
|
Phase 1 | |
Terminated |
NCT05301062 -
A Research Called CREDIT Studies How Safe the Study Treatment Radium-223 is and How Well it Works in Chinese Men With Advanced Prostate Cancer That Has Spread to the Bones and Does Not Respond to Treatments for Lowering Testosterone Levels
|
||
Recruiting |
NCT05383079 -
Combination of Radium-223 and Lutetium-177 PSMA-I&T in Men With Metastatic Castration-Resistant Prostate Cancer
|
Phase 1/Phase 2 | |
Active, not recruiting |
NCT04060394 -
Dose-Escalation and Efficacy Study of LAE001/Prednisone Plus Afuresertib Patients With m-CRPC
|
Phase 1/Phase 2 | |
Completed |
NCT01942837 -
Study of Enzalutamide in Patients With Castration-resistant Prostate Cancer
|
Phase 2 | |
Recruiting |
NCT05458544 -
[Lu-177]Ludotadipep in Castration-resistant Prostate Cancer(CRPC): Investigation of Drug and Application
|
Phase 1/Phase 2 | |
Withdrawn |
NCT04879589 -
Phase 1 Study of ATRS-2002 in Healthy Male Adults
|
Phase 1 | |
Recruiting |
NCT03230734 -
Sequencing of Radium-223 and Docetaxel in Symptomatic Bone-only Metastatic Castration-resistant Prostate Cancer
|
Phase 2 | |
Recruiting |
NCT05116579 -
Circulating Tumor DNA (ctDNA) Monitoring in the Assessment and Prediction of the Efficacy of PARP Inhibitors (PARPi)
|
||
Active, not recruiting |
NCT03732820 -
Study on Olaparib Plus Abiraterone as First-line Therapy in Men With Metastatic Castration-resistant Prostate Cancer
|
Phase 3 | |
Recruiting |
NCT05005728 -
XmAb®20717 (Vudalimab) Alone or in Combination With Chemotherapy or Targeted Therapy in Patients With Metastatic Castration-Resistant Prostate Cancer
|
Phase 2 | |
Recruiting |
NCT05762536 -
Docetaxel or Cabazitaxel With or Without Darolutamide in mCRPC
|
Phase 2 |