A Single Arm Phase II Trial of Zanzalitinib in Patients With Metastatic Castration Resistant Prostate Cancer (mCRPC) With Soft Tissue or Visceral Metastases
Pedro Barata, MD, MSc
Summary
This research study is for people with metastatic castrate-resistant prostate cancer (mCRPC). Zanzalintinib is a new drug that shows activity in mCRPC with soft tissue or visceral metastases who have progressed on prior treatment. Participants can stay in the research for up to 24 months as long as they experience clinical benefit from it. The purpose of this study is to learn if Zanzalinitib is effective in treating metastatic castrate-resistant prostate cancer.
Description
Prostate cancer is one of the most common cancers that affect males. Metastatic prostate cancer is treated at first with androgen deprivation therapy (ADT) and androgen receptor pathways inhibitors (ARPI). It is initially responsive to these treatments, but overtime it progresses from being hormone-sensitive to become castrate resistant, which leads to poorer outcomes. There have been other therapies that have been approved for treatment of metastatic castrate-resistant prostate cancer (mCRPC), but there are high-risk features such as high tumor burden, shorter time from diagnosis to metastati…
Eligibility
- Age range
- 18+ years
- Sex
- Male
- Healthy volunteers
- No
Inclusion Criteria: * Participants must have histologically or cytologically confirmed metastatic castrate-resistant prostate cancer. Adenocarcinoma of prostate must be primary histology, but neuroendocrine features are allowed as long as \<50% neuroendocrine histology. Tissue is not mandatory, but a pathologic report is required at time of participant enrollment. * Participants must have evidence of metastatic disease in soft tissue or visceral disease on conventional scans including CT and bone scans * Participants must have previously been treated with an ARPI (abiraterone, enzalutamide, a…
Interventions
- DrugZanzalintinib
60mg zanzalinitib will be given daily starting on Cycle 1 Day 1 until disease progression or unacceptable toxicity
Location
- University Hospitals Cleveland Medical Center, Case Comprehensive Cancer CenterCleveland, Ohio