Ignite Creation Date:
2025-12-24 @ 9:22 PM
Ignite Modification Date:
2025-12-25 @ 7:09 PM
Study NCT ID:
NCT03456804
Status:
COMPLETED
Last Update Posted:
2023-07-14
First Post:
2018-02-09
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
ESK981 in Treating Patients With Metastatic Castrate-Resistant Prostate Cancer
Sponsor:
Barbara Ann Karmanos Cancer Institute
Organization:
Study Overview
Official Title:
An Open-Label, Parallel, Phase II Study of Single-Agent Oral ESK981 in Men With Castrate-Resistant Prostate Cancer (CRPC)
Status:
COMPLETED
Status Verified Date:
2023-06
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 trials studies the side effects and how well ESK981 works in treating patients with castration-resistant prostate cancer that has spread to other places in the body. ESK981 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
Detailed Description:
PRIMARY OBJECTIVES:
I. To determine the PSA \>= 50% response rate (PSA50) from baseline using the Prostate Cancer Working Group 3 (PCWG3) criteria to pan-VEGFR/TIE2 tyrosine kinase inhibitor CEP-11981 (ESK981) as a single agent in men with castration-resistant prostate cancer (CRPC) who have progressed on enzalutamide (an oral androgen-receptor inhibitor) and/or abiraterone acetate (an androgen synthesis inhibitor).
II. To assess the safety and tolerability of ESK981 as a single agent.
SECONDARY OBJECTIVES:
I. To determine the time to PSA response to ESK981 in metastatic CRPC patients. II. To determine the duration of PSA response to ESK981 in metastatic CRPC patients.
III. To determine PSA progression rates and PSA progression free survival (PFS), as defined by the PCWG3 criteria.
TERTIARY OBJECTIVES:
I. To assess exploratory biomarkers from blood and tumor biopsies.
OUTLINE:
Patients receive pan-VEGFR/TIE2 tyrosine kinase inhibitor CEP-11981 orally (PO) once daily (QD) for 5 days (Monday-Friday). Treatment repeats for up to 8 weeks in the absence of disease progression or unacceptable toxicity. If treatment is successful after 8 weeks, patients may receive up to 6 months of pan-VEGFR/TIE2 tyrosine kinase inhibitor CEP-11981.
After completion of study treatment, patients are followed up periodically.
I. To determine the PSA \>= 50% response rate (PSA50) from baseline using the Prostate Cancer Working Group 3 (PCWG3) criteria to pan-VEGFR/TIE2 tyrosine kinase inhibitor CEP-11981 (ESK981) as a single agent in men with castration-resistant prostate cancer (CRPC) who have progressed on enzalutamide (an oral androgen-receptor inhibitor) and/or abiraterone acetate (an androgen synthesis inhibitor).
II. To assess the safety and tolerability of ESK981 as a single agent.
SECONDARY OBJECTIVES:
I. To determine the time to PSA response to ESK981 in metastatic CRPC patients. II. To determine the duration of PSA response to ESK981 in metastatic CRPC patients.
III. To determine PSA progression rates and PSA progression free survival (PFS), as defined by the PCWG3 criteria.
TERTIARY OBJECTIVES:
I. To assess exploratory biomarkers from blood and tumor biopsies.
OUTLINE:
Patients receive pan-VEGFR/TIE2 tyrosine kinase inhibitor CEP-11981 orally (PO) once daily (QD) for 5 days (Monday-Friday). Treatment repeats for up to 8 weeks in the absence of disease progression or unacceptable toxicity. If treatment is successful after 8 weeks, patients may receive up to 6 months of pan-VEGFR/TIE2 tyrosine kinase inhibitor CEP-11981.
After completion of study treatment, patients are followed up periodically.
Study Oversight
Has Oversight DMC:
True
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?:
False
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NCI-2017-02330 | REGISTRY | CTRP (Clinical Trial Reporting Program) | View | |
| 2017-065 | OTHER | Wayne State University/Karmanos Cancer Institute | View | |
| P30CA022453 | NIH | None | https://reporter.nih.gov/quic… | View |