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Androgen Synthesis Inhibitor
ARV-110 + Abiraterone for Prostate Cancer
Phase 1
Waitlist Available
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
- Rising PSAs at least 16 weeks after initiation of abiraterone
Ongoing treatment with stable doses of abiraterone (on an empty stomach) and a concomitant corticosteroid for metastatic castration-resistant prostate cancer (mCRPC) or for metastatic castration sensitive prostate cancer (mCSPC) until Cycle 1, Day 1 (C1D1)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 35 days after subject discontinues study treatment
Awards & highlights
Study Summary
This trial is testing a new combination therapy for metastatic prostate cancer.
Who is the study for?
Men with metastatic castration-resistant prostate cancer who have rising PSA levels despite ongoing abiraterone treatment. They should be in good physical condition (ECOG status of 0 or 1) and on stable hormone therapy. Excluded are those with recent major surgery, uncontrolled infections, severe heart conditions, electrolyte imbalances, brain metastases requiring steroids, or other active cancers.Check my eligibility
What is being tested?
The trial is testing the combination of a new drug called ARV-110 with an existing medication named Abiraterone to see if it can help men whose prostate cancer continues to progress as indicated by rising PSA levels even after being treated with Abiraterone alone.See study design
What are the potential side effects?
Potential side effects may include typical reactions from cancer medications such as fatigue, digestive issues like nausea or diarrhea, hormonal changes affecting mood and energy levels. Specific side effects related to ARV-110 aren't detailed but could align with common treatments for advanced prostate cancer.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My PSA levels have increased 16 weeks after starting abiraterone.
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I am currently on stable doses of abiraterone and a steroid for my metastatic prostate cancer.
Select...
My PSA levels have increased 16 weeks after starting abiraterone.
Select...
My prostate cancer diagnosis was confirmed through a lab test.
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I am fully active or restricted in physically strenuous activity but can do light work.
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My PSA levels have increased twice after starting abiraterone treatment.
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I am currently on abiraterone and not showing signs of cancer progression.
Select...
I am currently on stable doses of abiraterone and a steroid for my advanced prostate cancer.
Select...
I am currently benefiting from abiraterone without signs of my cancer worsening on scans.
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My PSA levels have increased twice after starting abiraterone treatment.
Select...
I am currently on hormone therapy for cancer or have had an orchiectomy.
Select...
I am currently on hormone therapy for cancer or have had an orchiectomy.
Select...
My prostate cancer diagnosis was confirmed through a lab test.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 35 days after subject discontinues study treatment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~35 days after subject discontinues study treatment
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of dose limiting toxicities 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
Number of Patients with Adverse Events as a measure of safety and tolerability of ARV-110 in combination with abiraterone
+1 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Oral tablet(s) in combination with abiraterone and a corticosteroid.Experimental Treatment1 Intervention
ARV-110 oral tablets in combination with abiraterone and a corticosteroid administered daily in 28 day cycles.
Find a Location
Who is running the clinical trial?
Arvinas Androgen Receptor, Inc.Lead Sponsor
3 Previous Clinical Trials
476 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have any active, uncontrolled infections including HIV/AIDS or hepatitis.My PSA levels have increased 16 weeks after starting abiraterone.My PSA levels have increased 16 weeks after starting abiraterone.I am currently on stable doses of abiraterone and a steroid for my metastatic prostate cancer.I have stomach or bowel issues but not severe acid reflux needing strong medication.I haven't had any cancer except for certain skin cancers or localized cancer that hasn't spread in the last 3 years.I have not had major surgery within the last 4 weeks.My prostate cancer diagnosis was confirmed through a lab test.I am fully active or restricted in physically strenuous activity but can do light work.I have brain metastases that are either untreated or need steroids.My PSA levels have increased twice after starting abiraterone treatment.I am currently on abiraterone and not showing signs of cancer progression.I have been treated with specific prostate cancer medications or experimental therapies.I am not on medications that interact badly with the trial drugs.I have had serious heart rhythm problems in the last 6 months.My liver disease is severe (Child-Pugh C).My high blood pressure is not controlled by medication.I am currently on stable doses of abiraterone and a steroid for my advanced prostate cancer.I haven't had radiation therapy in the last 4 weeks or to more than 25% of my bone marrow.I am currently benefiting from abiraterone without signs of my cancer worsening on scans.My PSA levels have increased twice after starting abiraterone treatment.I am currently on hormone therapy for cancer or have had an orchiectomy.I am currently on hormone therapy for cancer or have had an orchiectomy.I haven't had chemotherapy, immunotherapy, or other cancer treatments except for GnRH agonists in the last 28 days.My prostate cancer diagnosis was confirmed through a lab test.I have not had a heart attack, severe chest pain, heart surgery, stroke, or significant blood clot in the last year.
Research Study Groups:
This trial has the following groups:- Group 1: Oral tablet(s) in combination with abiraterone and a corticosteroid.
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has there been previous research exploring the synergy between ARV-110 and Abiraterone?
"ARV-110 in Combination with Abiraterone was initially studied at Rosemere Cancer Centre at Royal Preston Hospital more than 15 years ago. At present, 100 trials have been completed while 98 are actively being conducted across multiple sites, a significant portion of which is located in Columbus, Ohio."
Answered by AI
What has been revealed regarding the safety of ARV-110 in conjunction with Abiraterone?
"Our assessment rated the safety of ARV-110 in Combination with Abiraterone a 1 due to it being in Phase 1, where there is only limited evidence for its efficacy and safety."
Answered by AI
Are there still vacancies for participants in the clinical trial?
"Clinicaltrials.gov confirms that this research project is actively inviting volunteers to participate, having been first published on February 1st 2022 and recently edited October 26th of the same year."
Answered by AI
What is the aggregate size of this investigation's cohort?
"Affirmative. Clinicaltrials.gov data points to this investigation being open for applicants, the first advertisement having been released on February 1st 2022 and latest update being issued on October 26th 2022. 40 study participants must be recruited from 12 different sites."
Answered by AI
How many locations are carrying out this clinical trial?
"The 12 sites presently running this trial are sprawled across the United States, including Columbus, Fort Myers, and Tampa. To reduce travel requirements if participating in the study, you may want to select a location closest to your residence."
Answered by AI
Who else is applying?
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
1
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