NCT03888612

Trial of ARV-110 in Patients With Metastatic Castration Resistant Prostate Cancer

A Phase 1/2, Open-label, Dose Escalation, and Cohort Expansion Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ARV-110 in Patients With Metastatic Castration Resistant Prostate Cancer

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 248 (actual)
• Sponsor: Arvinas Inc. · Industry
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Phase 1/2 dose escalation study to assess the safety and tolerability of ARV-110 in men with mCRPC who have progressed on prior approved systemic therapies for their castrate resistant disease (one of which must be enzalutamide or abiraterone).

Conditions

• Prostate Cancer Metastatic

Interventions

Type	Name	Description
DRUG	ARV-110	Part A: Daily oral dosages are predetermined by cohort review committee after the initial starting dose cohort after the first 28 days of treatment Part B: Daily oral dosage and schedule at a recommended Phase 2 dose based on data from Part A

Timeline

• Start date: 2019-03-01
• Primary completion: 2024-04-29
• Completion: 2025-01-27
• First posted: 2019-03-25
• Last updated: 2025-04-01

Locations

54 sites across 1 country: United States

Regulatory

• FDA-regulated drug study