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Protocol # 21-731

Status

Recruiting

Description

Phase 1b study to assess the combination of ARV-110 and abiraterone in patients with metastatic prostate cancer with rising PSA values on abiraterone.

Condition

  • Prostate Cancer Metastatic

Interventions

  • ARV-110 in Combination with Abiraterone

Phase

Phase 1

Study Type

Interventional

Further Study Details

Primary Outcome:

  • Incidence of dose limiting toxicities of ARV-110 in combination with abiraterone
  • Number of Patients with Adverse Events as a measure of safety and tolerability of ARV-110 in combination with abiraterone
  • Incidence of laboratory abnormalities as a measure of safety and tolerability of ARV-110 in combination with abiraterone
  • Recommended Phase 2 dose (RP2D)/schedule for the combination

Enrollment

40

Study Start Date

February 1, 2022

Eligibility

  • Gender:     Male
  • Minimum age:     18 Years
  • Maximum age:     N/A
  • Healthy volunteers:     No

Sponsors

Arvinas Androgen Receptor, Inc.

Source

Arvinas Inc.

Official title

A Phase 1b Open-Label, Clinical Trial to Evaluate the Safety, Tolerability, and Pharmacokinetics of ARV-110 in Combination With Abiraterone in Patients With Metastatic Prostate Cancer

Clinicaltrials.gov Identifier

NCT05177042

     

Source: Clinicaltrials.gov. Through our founding membership in the Dana-Farber/Harvard Cancer Center, an NCI-designated Comprehensive Cancer Center, these clinical trials are conducted at the Massachusetts General Hospital Cancer Center and may be available at other partner institutions.