Study on ARV-766 Taken Orally in Men with Metastatic Prostate Cancer

Sponsor: Novartis Pharmaceuticals

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT05067140

This clinical trial is testing the safety and effectiveness of a new oral medication, ARV-766, alone or with another drug, abiraterone, in men with prostate cancer that has spread to other parts of the body.

Patient Parameters

Program Overview

The purpose of this study is to evaluate how safe and effective the oral medication ARV-766 is, either by itself or combined with abiraterone, for treating men with prostate cancer that has spread beyond the prostate. The study is divided into different parts to assess various treatment scenarios.

Eligibility Criteria

Inclusion Criteria

  • Confirmed diagnosis of prostate cancer.
  • Currently receiving hormone therapy to lower testosterone levels or have had surgery to remove the testicles.
  • Good overall health with an ECOG performance status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.

Part A:

  • Cancer has progressed after at least two previous treatments for metastatic prostate cancer, including one second-generation hormone therapy like abiraterone or enzalutamide.
  • Cancer is resistant to hormone therapy.

Part B:

  • Have used one to three second-generation hormone therapies like enzalutamide or abiraterone.
  • Have had no more than two chemotherapy treatments.
  • Cancer is resistant to hormone therapy.

Part C & D:

  • Have prostate cancer that is either resistant or sensitive to hormone therapy and has spread to other parts of the body, as shown by scans.

Exclusion Criteria

Part A and B:

  • Have brain cancer that requires steroid treatment.
  • Have active digestive issues like chronic diarrhea or have had certain stomach surgeries.
  • Have had radiation therapy within 4 weeks before starting the study drug or radiation to more than 25% of the bone marrow.
  • Have taken an experimental drug within 4 weeks before starting the study.
  • Have had cancer treatment within 2 weeks before starting the study, except for hormone therapy to maintain low testosterone levels. For certain drugs like bicalutamide, mitomycin C, or nitrosoureas, the waiting period is 6 weeks, and for abiraterone, it's 4 weeks.

Part C and D:

  • Have previously been treated with a second-generation hormone therapy.

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