Ignite Creation Date:
2024-05-06 @ 6:30 PM
Last Modification Date:
2024-10-26 @ 2:49 PM
Study NCT ID:
NCT05689021
Status:
RECRUITING
Last Update Posted:
2024-05-13
First Post:
2023-01-09
Brief Title:
CJNJ-67652000 and Prednisone for Treatment of Metastatic Castration-Resistant Prostate Cancer and SPOP Gene Mutations
Sponsor:
Mayo Clinic
Organization:
Mayo Clinic
Study Overview
Official Title:
Phase 2 Study of CJNJ-67652000 NiraparibAbiraterone Acetate Fixed-Dose Combination and Prednisone for Metastatic Castration-Resistant Prostate Cancer Associated With SPOP Mutation With or Without Homologous Recombination Deficiency
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This phase II trial tests how well abiraterone acetateniraparib CJNJ-67652000 niraparibabiraterone acetate fixed-dose combination and prednisone works in treating patients with castration-resistant prostate cancer that has spread from where it first started primary site to other places in the body metastatic and who have a mutation in the SPOP gene CJNJ-67652000 niraparibabiraterone acetate fixed-dose combination is a drug which stops certain cancer cells from being able to repair themselves from damage leading to the death of the cancer cell Prednisone is in a class of medications called corticosteroids It is used to reduce inflammation and lower the bodys immune response to help lessen the side effects of chemotherapy drugs Giving CJNJ-67652000 and prednisone may kill more tumor cells in patients with metastatic prostate cancer than giving these drugs alone
Detailed Description:
PRIMARY OBJECTIVE
I To determine the efficacy of abiraterone acetateniraparib CJNJ-67652000 niraparibabiraterone acetate fixed-dose combination and prednisone as assessed by prostate-specific antigen decline 50 PSA50 response rate in patients with metastatic castrate-resistant prostate cancer mCRPC who have failed prior treatment with androgen receptor AR-targeted therapy and have a qualifying deleterious SPOP mutation
SECONDARY OBJECTIVES
I To assess the radiologic progression free survival rPFS of CJNJ-67652000 niraparibabiraterone acetate fixed-dose combination and prednisone treatment in patients with mCRPC who have failed prior treatment with AR-targeted therapy and have a qualifying deleterious SPOP mutation
II To assess best radiographic response using Prostate Cancer Working Group 3 PCWG3 criteria
III To assess time to prostate specific antigen PSA progression IV To assess safety and tolerability using National Cancer Institute NCI Common Toxicity Criteria Version 50
CORRELATIVE RESEARCH OBJECTIVES
I To explore the landscape of genomic alterations occurring after use of CJNJ-67652000 niraparibabiraterone acetate fixed-dose combination and prednisone
II To use blood tissue or organoid lines for identifying predictive biomarkers of response investigating drug resistance mechanisms and for future drug efficacy studies
III To explore the relationship of other genomic alterations in the tumor tissue with overall response rate ORR and disease progression
OUTLINE
Patients receive CJNJ-67652000 orally PO and prednisone PO on study Patients also undergo blood specimen collection computed tomography CT or magnetic resonance imaging MRI and bone scan throughout the trial
I To determine the efficacy of abiraterone acetateniraparib CJNJ-67652000 niraparibabiraterone acetate fixed-dose combination and prednisone as assessed by prostate-specific antigen decline 50 PSA50 response rate in patients with metastatic castrate-resistant prostate cancer mCRPC who have failed prior treatment with androgen receptor AR-targeted therapy and have a qualifying deleterious SPOP mutation
SECONDARY OBJECTIVES
I To assess the radiologic progression free survival rPFS of CJNJ-67652000 niraparibabiraterone acetate fixed-dose combination and prednisone treatment in patients with mCRPC who have failed prior treatment with AR-targeted therapy and have a qualifying deleterious SPOP mutation
II To assess best radiographic response using Prostate Cancer Working Group 3 PCWG3 criteria
III To assess time to prostate specific antigen PSA progression IV To assess safety and tolerability using National Cancer Institute NCI Common Toxicity Criteria Version 50
CORRELATIVE RESEARCH OBJECTIVES
I To explore the landscape of genomic alterations occurring after use of CJNJ-67652000 niraparibabiraterone acetate fixed-dose combination and prednisone
II To use blood tissue or organoid lines for identifying predictive biomarkers of response investigating drug resistance mechanisms and for future drug efficacy studies
III To explore the relationship of other genomic alterations in the tumor tissue with overall response rate ORR and disease progression
OUTLINE
Patients receive CJNJ-67652000 orally PO and prednisone PO on study Patients also undergo blood specimen collection computed tomography CT or magnetic resonance imaging MRI and bone scan throughout the trial
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-2022-10798 | REGISTRY | None | None |
| 21-010477 | OTHER | Mayo Clinic Institutional Review Board | None |