Ignite Creation Date:
2024-05-06 @ 3:46 PM
Last Modification Date:
2024-10-26 @ 1:57 PM
Study NCT ID:
NCT04754425
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-05-16
First Post:
2021-02-10
Brief Title:
Erdafitinib for the Treatment of Patients With Castration-Resistant Prostate Cancer
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
A Study of Erdafitinib in Castration-Resistant Prostate Cancer Patients Evaluating Markers of Bone Remodeling and FGF Signaling in Plasma and Bone Marrow
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This phase II trial studies the effect of erdafitinib in treating patients with prostate cancer that grows and continues to spread despite the surgical removal of the testes or drugs to block androgen production castration-resistant Erdafitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth Giving erdafitinib may help control disease in patients with castration-resistant prostate cancer In addition studying samples of blood tissue plasma and bone marrow from patients with castration-resistant prostate cancer in the laboratory may help doctors learn more about changes that occur in deoxyribonucleic acid DNA and identify biomarkers related to cancer
Detailed Description:
PRIMARY OBJECTIVE
I To evaluate efficacy of erdafitinib in subjects with advanced prostate cancer who have progressed on a second-generation androgen receptor AR-targeting agents SART
SECONDARY OBJECTIVES
I To evaluate the objective response rate II To measure Time on Treatment ToT as a surrogate of clinical efficacy and Progression-Free Survival PFS III To measure PFS IV To correlate bone specific alkaline phosphatase BAP modulation with response ToT and PFS
V To correlate prostate specific antigen PSA modulation with response ToT and PFS
VI To characterize the safety profile of subjects treated with erdafitinib VII To measure overall survival VIII To collect and archive bone marrow biopsies and aspirates serum and plasma in study patients for later hypothesis generating associations
EXPLORATORY OBJECTIVE
I To evaluate DNA ribonucleic acid RNA or protein biomarkers in tissue and blood samples which potentially predict tumor response or resistance to erdafitinib
OUTLINE
Patients receive erdafitinib orally PO once daily QD on days 1-21 Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity Patients may also undergo collection of blood and bone marrow via biopsy and aspirates
After completion of study treatment patients are followed up at 30 days every 16 weeks for 1 year and then every 6 months thereafter
I To evaluate efficacy of erdafitinib in subjects with advanced prostate cancer who have progressed on a second-generation androgen receptor AR-targeting agents SART
SECONDARY OBJECTIVES
I To evaluate the objective response rate II To measure Time on Treatment ToT as a surrogate of clinical efficacy and Progression-Free Survival PFS III To measure PFS IV To correlate bone specific alkaline phosphatase BAP modulation with response ToT and PFS
V To correlate prostate specific antigen PSA modulation with response ToT and PFS
VI To characterize the safety profile of subjects treated with erdafitinib VII To measure overall survival VIII To collect and archive bone marrow biopsies and aspirates serum and plasma in study patients for later hypothesis generating associations
EXPLORATORY OBJECTIVE
I To evaluate DNA ribonucleic acid RNA or protein biomarkers in tissue and blood samples which potentially predict tumor response or resistance to erdafitinib
OUTLINE
Patients receive erdafitinib orally PO once daily QD on days 1-21 Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity Patients may also undergo collection of blood and bone marrow via biopsy and aspirates
After completion of study treatment patients are followed up at 30 days every 16 weeks for 1 year and then every 6 months thereafter
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 |
|---|---|---|---|
| 2020-0953 | OTHER | M D Anderson Cancer Center | None |
| NCI-2021-00663 | REGISTRY | None | None |