Ignite Creation Date:
2024-05-06 @ 6:39 PM
Last Modification Date:
2024-10-26 @ 2:51 PM
Study NCT ID:
NCT05730712
Status:
RECRUITING
Last Update Posted:
2024-03-12
First Post:
2023-02-07
Brief Title:
Pertuzumab Trastuzumab Hyaluronidase-zzxf and Enzalutamide for Treatment of Metastatic Castration-Resistant Prostate Cancer
Sponsor:
Mayo Clinic
Organization:
Mayo Clinic
Study Overview
Official Title:
Phase II Trial of Pertuzumab Trastuzumab and Hyaluronidase-zzxf HP Plus Enzalutamide for the Treatment of Selected Patients With Metastatic Castration-Resistant Prostate Cancer TraPPer
Status:
RECRUITING
Status Verified Date:
2024-03
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 pertuzumab trastuzumab hyaluronidase-zzxf and enzalutamide works in treating patients with castration-resistant prostate cancer that has spread from where it first started to other places in the body metastatic Pertuzumab and trastuzumab are monoclonal antibodies and forms of targeted therapy that attach to a receptor protein called human epidermal growth factor receptor-2 HER2 HER2 is found on some cancer cells When pertuzumab or trastuzumab attach to HER2 the signals that tell the cells to grow are blocked and the tumor cell may be marked for destruction by the bodys immune system Hyaluronidase is an endoglycosidase It helps to keep pertuzumab and trastuzumab in the body longer so that these medications will have a greater effect Hyaluronidase also allows pertuzumab and trastuzumab to be given by injection under the skin and shortens their administration time compared to pertuzumab or trastuzumab alone Chemotherapy drugs such as enzalutamide work in different ways to stop the growth of cancer cells either by killing the cells by stopping them from dividing or by stopping them from spreading Giving pertuzumab trastuzumab hyaluronidase-zzxf and enzalutamide may kill more cancer cells
Detailed Description:
PRIMARY OBJECTIVE
I Evaluate the combination of pertuzumab trastuzumab and hyaluronidase-zzxf plus enzalutamide in enzalutamide-refractory metastatic castration-resistant prostate cancer mCRPC in improving objective response rate among patients with measurable disease Prostate Cancer Clinical Trials Working Group 3 PCWG 30
SECONDARY OBJECTIVES
I Evaluate this combination for radiographic progression-free survival at 6 months
II Evaluate this combination for overall survival at 12 months
EXPLORATORY OBJECTIVES
I Assessment of this combination for adverse events according to clinical judgment and patient-reported outcomes Patient Reported Outcomes-Common Terminology Criteria for Adverse Events PRO-CTCAE - Prostate Cancer
II Assessment of patient quality of life using Functional Assessment of Cancer Therapy- Prostate FACT-P questionnaire
CORRELATIVE OBJECTIVES
I Determine the correlation between outcomes as above and systemic NRG-1 levels at baseline and over time
II Determine the correlation between outcomes as above and change in HER2HER3androgen receptor AR gene signatures
OUTLINE
Patients receive pertuzumab trastuzumab and hyaluronidase-zzxf subcutaneously SC and enzalutamide orally PO on study Patients undergo echocardiography ECHO biopsy computed tomography CT and magnetic resonance imaging MRI scans Patients also undergo collection of blood and tissue samples
I Evaluate the combination of pertuzumab trastuzumab and hyaluronidase-zzxf plus enzalutamide in enzalutamide-refractory metastatic castration-resistant prostate cancer mCRPC in improving objective response rate among patients with measurable disease Prostate Cancer Clinical Trials Working Group 3 PCWG 30
SECONDARY OBJECTIVES
I Evaluate this combination for radiographic progression-free survival at 6 months
II Evaluate this combination for overall survival at 12 months
EXPLORATORY OBJECTIVES
I Assessment of this combination for adverse events according to clinical judgment and patient-reported outcomes Patient Reported Outcomes-Common Terminology Criteria for Adverse Events PRO-CTCAE - Prostate Cancer
II Assessment of patient quality of life using Functional Assessment of Cancer Therapy- Prostate FACT-P questionnaire
CORRELATIVE OBJECTIVES
I Determine the correlation between outcomes as above and systemic NRG-1 levels at baseline and over time
II Determine the correlation between outcomes as above and change in HER2HER3androgen receptor AR gene signatures
OUTLINE
Patients receive pertuzumab trastuzumab and hyaluronidase-zzxf subcutaneously SC and enzalutamide orally PO on study Patients undergo echocardiography ECHO biopsy computed tomography CT and magnetic resonance imaging MRI scans Patients also undergo collection of blood and tissue samples
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-2022-10773 | REGISTRY | None | None |
| MC210504 | OTHER | None | None |
| 21-013057 | OTHER | Mayo Clinic Institutional Review Board | None |