Open Label Phase II Trial of Cabozantinib in Patients With Metastatic Castrate Resistant Prostate Cancer (mCRPC) and Known Amplifications or Activating Mutations in Gene Targets of Cabozantinib Who Have Received Prior Anti-Androgen Therapy

Clinical Trial Details

This is a clinical trial for adult men with metastatic castrate resistant prostate cancer. The main purpose of this study is to evaluate the safety of the investigational drug Cabozantinib to see what its side effects are and if it works for this type of cancer.

Cabozantinib (Cometriq™, Cabometyx™) is an oral medication that blocks activity of specific proteins in the body. Cabozantinib is being experimentally tested for prostate cancer and is not yet approved by the United States Food and Drug Administration (FDA) as a standard of care option. Cabozantinib is FDA-approved for other forms of cancer.

All people participating in this study will be treated with cabozantinib and will continue to take luteinizing hormone-releasing hormone (LHRH) analogue therapy.

Participants will be in the study for approximately 12 months after enrollment. At that point, they will switch to long-term follow up for two years after completing the study.

Key Eligibility:

Open to men above the age of 18 with a diagnosis of prostate cancer.
Participants must not be previously exposed to any type of small molecule kinase inhibitor (including investigational kinase inhibitor) within 2 weeks before first dose of study treatment.

Detailed eligibility will be reviewed when you contact the study team.

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Study contact by location

Upper East Side - Manhattan

Contact(s)

646-962-2072
guonc@med.cornell.edu

Primary Investigator(s)

David M Nanus, MD

Protocol ID(s)

Weill Cornell Medicine IRB #:

1904020287

ClinicalTrials.gov:

NCT04631744

Status

Open to Enrollment

Age Group

Adult

Disease

Prostate Cancer