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Androgen Receptor Degrader

ARV-110 for Prostate Cancer (mCRPC Trial)

Phase 1 & 2
Waitlist Available
Research Sponsored by Arvinas Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients must have ongoing ADT with a gonadotropin releasing hormone analog or inhibitor, or orchiectomy (surgical or medical castration).
Patients must have progressed on at least 2 prior approved systemic therapies for CRPC (at least one must be abiraterone or enzalutamide).
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 28 days
Awards & highlights

mCRPC Trial Summary

This trial is testing a new cancer drug in men who have prostate cancer that has spread and progressed despite treatment with other drugs. The study will assess how well the new drug is tolerated and how safe it is.

Who is the study for?
This trial is for men over 18 with advanced prostate cancer that's resistant to castration treatments. They should have progressed after systemic therapies but not had chemotherapy for their metastatic condition. Participants must be on hormone therapy or have had an orchiectomy, and can't have used more than two second-generation anti-androgens.Check my eligibility
What is being tested?
The study tests ARV-110's safety and how well it's tolerated in different doses among men with metastatic castration-resistant prostate cancer (mCRPC). It targets those who've seen their disease progress despite previous treatments like enzalutamide or abiraterone.See study design
What are the potential side effects?
Specific side effects of ARV-110 are not listed, but common ones may include fatigue, nausea, changes in appetite, skin reactions at the injection site, and potential hormonal imbalances due to its action on testosterone levels.

mCRPC Trial 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.
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My prostate cancer has worsened after two treatments, including abiraterone or enzalutamide.
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I have taken 1 or 2 treatments like enzalutamide or abiraterone for prostate cancer.
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I have had only one type of advanced hormone therapy for my prostate cancer.
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I have never received chemotherapy.
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I have had only one chemotherapy treatment for both early and advanced prostate cancer.
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My prostate cancer is advanced, has spread, and does not respond to hormone therapy.
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My prostate cancer is worsening despite treatment.
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I am a man and at least 18 years old.

mCRPC Trial 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-110
Part A: Incidence of laboratory abnormalities as a measure of safety and tolerability of ARV-110
Part A: Number of Patients with Adverse Events as a measure of safety and tolerability of ARV-110
+3 more
Secondary outcome measures
Part A: Anti-tumor activity based on the duration of response in the entire study population and in the subsets of patient based on the AR mutational status of their tumor.
Part A: Anti-tumor activity based on the overall PSA response in the entire study population and in the subsets of patient based on the AR mutational status of their tumor.
Part A: Anti-tumor activity based on the overall RECIST response in the entire study population and in the subsets of patient based on the AR mutational status of their tumor.
+13 more

mCRPC Trial Design

1Treatment groups
Experimental Treatment
Group I: ARV-110Experimental Treatment1 Intervention
Part A: Oral tablet(s), once or twice daily in 28 day cycles Part B: Oral tablet(s), once or twice daily in 28 day cycles

Find a Location

Who is running the clinical trial?

Arvinas Inc.Lead Sponsor
2 Previous Clinical Trials
367 Total Patients Enrolled
Arvinas Androgen Receptor, Inc.Lead Sponsor
3 Previous Clinical Trials
266 Total Patients Enrolled

Media Library

ARV-110 (Androgen Receptor Degrader) Clinical Trial Eligibility Overview. Trial Name: NCT03888612 — Phase 1 & 2
Prostate Cancer Research Study Groups: ARV-110
Prostate Cancer Clinical Trial 2023: ARV-110 Highlights & Side Effects. Trial Name: NCT03888612 — Phase 1 & 2
ARV-110 (Androgen Receptor Degrader) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03888612 — Phase 1 & 2

Frequently Asked Questions

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

How many venues are currently hosting this research endeavor?

"This trial currently has 100 available slots across multiple sites, including Tennessee Oncology - Skyline in Nashville, Tennessee Oncology in Hendersonville and Florida Cancer Specialists - North - St. Anthony's in Saint Petersburg, alongside numerous other clinics."

Answered by AI

Are there any opportunities presently available to join this experiment?

"As per the data on clinicaltrials.gov, this medical trial is still open and recruiting patients. It was first advertised in March of 2019 and its details were most recently amended in November 2021."

Answered by AI

What beneficial results should we anticipate from this research?

"The primary goal of this experiment, which is set to conclude in 28 days time, will be the evaluation of ARV-110's clinical anti-tumor activity when dealing with patients suffering from mCRPC (PSA measured PCWG and RECIST). Secondary objectives involve assessing its Anti-Tumor Activity based on duration response over the entire population, as well as subsets separated by their mutational status. Further PK parameters such as Cmin and Tmax are also going to be evaluated after single dose administrations, or multiple once/twice daily doses."

Answered by AI

How many participants is the research team recruiting for this project?

"This clinical trial necessitates 250 individuals, meeting the prerequisites for inclusion in the study. Interested participants can visit either Tennessee Oncology - Skyline in Nashville or Tennessee Oncology in Hendersonville to join this research endeavour."

Answered by AI
~0 spots leftby Mar 2024