NCT03456804

ESK981 in Treating Patients With Metastatic Castrate-Resistant Prostate Cancer

An Open-Label, Parallel, Phase II Study of Single-Agent Oral ESK981 in Men With Castrate-Resistant Prostate Cancer (CRPC)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 13 (actual)
• Sponsor: Barbara Ann Karmanos Cancer Institute · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Castration Levels of Testosterone
• Castration-Resistant Prostate Carcinoma
• Metastatic Prostate Carcinoma
• PSA Progression
• Stage IV Prostate Adenocarcinoma AJCC v7

Interventions

Type	Name	Description
DRUG	ESK981	Treatment with ESK981 for patients with metastatic castrate resistant prostate cancer

Timeline

• Start date: 2018-03-08
• Primary completion: 2023-03-15
• Completion: 2023-05-09
• First posted: 2018-03-07
• Last updated: 2023-07-14
• Results posted: 2023-07-14

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study