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Androgen Receptor Antagonist

ARV-766 +/- Abiraterone for Prostate Cancer

Phase 1 & 2
Recruiting
Research Sponsored by Arvinas Androgen Receptor, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Ongoing androgen deprivation therapy (ADT) with a gonadotropin releasing hormone analog or inhibitor, or orchiectomy (surgical or medical castration)
Part A: Progression on at least 2 prior approved systemic therapies for metastatic prostate cancer (at least one must be a second-generation androgen inhibitor, e.g., abiraterone, enzalutamide, darolutamide, apalutamide). Progressive mCRPC
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 28 days
Awards & highlights

Study Summary

This trial will test a new drug, ARV-766, to see if it is safe and effective in treating men with prostate cancer that has spread and is resistant to hormone therapy.

Who is the study for?
Men with metastatic prostate cancer who've had progression after at least two systemic therapies, including a second-generation androgen inhibitor. They must have an ECOG performance status of 0 or 1, be on ADT, and can't have had more than two chemo regimens. Exclusions include recent anti-cancer therapy, certain gastrointestinal conditions, symptomatic brain metastases requiring steroids, recent radiation therapy or investigational drugs.Check my eligibility
What is being tested?
The trial is testing ARV-766 alone (Part A&B) and in combination with abiraterone (Part C&D), taken orally for men with advanced prostate cancer. It's to see how safe they are and how well they work as treatments.See study design
What are the potential side effects?
While the specific side effects of ARV-766 aren't listed here, common side effects for similar prostate cancer medications may include fatigue, nausea, skin rash, hormonal changes like hot flashes or breast tenderness.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am currently on hormone therapy for cancer or have had an orchiectomy.
Select...
My prostate cancer has worsened despite two prior treatments, including a modern hormone therapy.
Select...
I have taken 1-3 types of specific prostate cancer drugs and no more than 2 chemotherapy treatments for my advanced prostate cancer.
Select...
I am fully active or restricted in physically strenuous activity but can do light work.
Select...
My prostate cancer has been confirmed by a lab test.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~28 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 28 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Part A: Incidence of Dose Limiting Toxicities of ARV-766
Part A: Incidence of laboratory abnormalities as a measure of safety and tolerability of ARV-766
Part A: Number of Patients with Adverse Events as a measure of safety and tolerability of ARV-766
+5 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: ARV-766 + AbirateroneExperimental Treatment1 Intervention
Oral tablets, once daily in 28 day cycles
Group II: ARV-766Experimental Treatment1 Intervention
Oral tablets, once daily in 28 day cycles

Find a Location

Who is running the clinical trial?

Arvinas Androgen Receptor, Inc.Lead Sponsor
3 Previous Clinical Trials
296 Total Patients Enrolled

Media Library

Prostate Cancer Clinical Trial 2023: ARV-766 Highlights & Side Effects. Trial Name: NCT05067140 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are people still able to join this research project?

"The online clinical trials database indicates that this study is actively looking for participants. This particular trial was originally posted on September 2nd, 2021 and has seen one update since then on October 28th, 2022."

Answered by AI

How many different hospitals are conducting this study?

"There are 15 sites currently running this study, spanning from Charlottesville to Detroit. If you are selected for the trial, it is important to choose a location close to minimize travel time and costs."

Answered by AI

How many individuals are being helped by this clinical trial?

"Yes, that is correct. The clinicaltrials.gov website has information indicating that the study is looking for recruitment of 150 patients from 15 different medical sites. The original posting was on September 2nd, 2021 and there was a recent update on October 28th, 2022."

Answered by AI

Who else is applying?

What state do they live in?
New York
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
A Study of ARV-766 Given by Mouth in Men With Metastatic Prostate Cancer
2021. "A Study of ARV-766 Given by Mouth in Men With Metastatic Prostate Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05067140.
All > Prostate Cancer Boston > Metastatic Prostate Cancer
~82 spots leftby Dec 2025
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