) A Phase 1/2 Open-Label, Dose-Escalation and Cohort Expansion Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ARV-766 in Patients with Metastatic Castration-Resistant Prostate Cancer

UVA Tracking #
HSR220253
Principal Investigator
Robert Dreicer
Contact
Contact Phone
Official Trial Title
A Phase 1/2 Open-Label, Dose-Escalation and Cohort Expansion Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ARV-766 in Patients with Metastatic Castration-Resistant Prostate Cancer
Study Description

The University of Virginia is participating in a clinical research study for adults ages 18 and over, who have Metastatic Castration-Resistant Prostate Cancer (mCRPC). The purpose of this study is to assess the safety and tolerability (good and bad effects) and how prostate cancer responds to two different doses of the investigational study drug (ARV-766) in men with metastatic cancer of the prostate who have progressed on prior approved systemic therapies for disease like yours (one of which must be enzalutamide, darolutamide, apalutamide or abiraterone). "Investigational" means the drug being tested has not been approved by any regulatory authority, for example, the United States Food and Drug Administration (FDA). The study also seeks to evaluate how the drug moves within the body after administration and what effects the drug has on your body after administration.

You will be in the study as long as there is evidence that the treatment is helpful for your prostate cancer and you are tolerating treatment well, which has the potential to be up to 1-2 years. However, the total length of treatment is unknown as you will continue to receive treatment in this study until your disease worsens, or you experience toxicity (side effects that are severe), you withdraw your consent from the study, or it is decided by the study doctor or sponsor to stop your participation. All drugs will be delivered via an oral tablet.

Study-related procedures that are being done beyond your standard of care will be provided at no cost to you or your insurance.

Additional information can be found here: https://clinicaltrials.gov/ct2/show/NCT05067140

uvacancertrials@hscmail.mcc.virginia.edu

Compensation

Reimbursed up to $175 per night for hotel. Reimbursed $.56 per mile for patients who travel more than 75 miles round trip