- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05177042
Trial of ARV-110 and Abiraterone in Patients With Metastatic Castration Resistant Prostate Cancer (mCRPC)
April 5, 2024 updated by: Arvinas Androgen Receptor, Inc.
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
Phase 1b study to assess the combination of ARV-110 and abiraterone in patients with metastatic prostate cancer with rising PSA values on abiraterone.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
40
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Arvinas Androgen Receptor, Inc.
- Phone Number: 475-345-3354
- Email: clinicaltrialsARV-110@arvinas.com
Study Locations
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British Columbia
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Vancouver, British Columbia, Canada
- Clinical Trial Site
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Ontario
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Toronto, Ontario, Canada
- Clinical Trial Site
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Quebec
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Montreal, Quebec, Canada
- Clinical Trial Site
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Caen, France
- Clinical Trial Site
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Paris, France
- Clinical Trial Site
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Villejuif, France
- Clinical Trial Site
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Preston, United Kingdom, PR2 9HT
- Clinical Trial Site
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England
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London, England, United Kingdom
- Clinical Trial Site
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Wales
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Cardiff, Wales, United Kingdom
- Clinical Trial Site
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California
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Santa Monica, California, United States, 91361
- Clinical Trial Site
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Connecticut
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New Haven, Connecticut, United States, 06519
- Clinical Trial Site
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Florida
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Fort Myers, Florida, United States, 33916
- Clinical Trial Site
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Massachusetts
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Boston, Massachusetts, United States, 02114
- Clinical Trial Site
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Ohio
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Columbus, Ohio, United States, 43210
- Clinical Trial Site
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Oregon
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Portland, Oregon, United States, 97239
- Clinical Trial Site
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South Carolina
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Myrtle Beach, South Carolina, United States, 29572
- Clinical Trial Site
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Tennessee
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Nashville, Tennessee, United States, 37203
- Clinical Trial Site
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Virginia
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Charlottesville, Virginia, United States, 22903
- Clinical Trial Site
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Histological, pathological, or cytological confirmed diagnosis of adenocarcinoma of the prostate.
- 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).
Recent PSA values must demonstrate:
- Rising PSAs at least 16 weeks after initiation of abiraterone
- At least 2 PSA values that are higher than the PSA nadir on abiraterone, measured at a minimum of 1 week apart . The screening PSA for this study may be used as the 2nd PSA value.
- No known radiographic evidence of disease progression while receiving abiraterone and clinically benefitting at the time of consent. If there is radiographic disease progression during screening, the patient may be considered eligible if, in the judgement of the investigator, the patient is clinically benefitting from abiraterone.
- Ongoing androgen deprivation therapy with a gonadotropin-releasing hormone (GnRH) analogue or inhibitor, or orchiectomy (surgical or medical castration).
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Exclusion Criteria:
- Previously treated with enzalutamide, apalutamide, darolutamide or experimental therapies (e.g., protein degraders or inhibitors) directed at the AR.
- Treatment with any chemotherapy, investigational agents, immunotherapy, or hormonal therapy other than GnRH agonists within 28 days of the start of treatment on protocol.
- Radiation therapy within 4 weeks of first dose of study drug or prior irradiation to >25% of the bone marrow.
- Patients taking agents that are either a) sensitive P-glycoprotein (P-gp), breast cancer resistance protein (BCRP) substrates, or CYP3A4 substrates, b) P-gp, BCRP, CYP3A4, or CYP2D6 substrates that have a narrow therapeutic index, c) strong CYP3A4 inhibitors or inducers, or d) any other prohibited and/or restricted medications described in the protocol.
- Major surgery (as judged by the Investigator) within 4 weeks of first dose of study drug.
- Untreated brain metastases or brain metastases requiring steroids
- Any other active malignancy within 3 years prior to enrollment, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ.
- Any of the following in the previous 12 months: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure (New York Heart Association class II, III or IV), cerebrovascular accident, transient ischemic attack, symptomatic pulmonary embolism, or other clinically significant episode of thromboembolic disease.
- Any of the following in the previous 6 months: congenital long QT syndrome, Torsade de Pointes, arrhythmias (including sustained ventricular tachyarrhythmia and ventricular fibrillation), left anterior hemiblock (bifascicular block), or ongoing cardiac dysrhythmias of National Cancer Institute (NCI) Common Toxicity Criteria for Adverse Events (CTCAE) Grade ≥2, atrial fibrillation of any grade (Grade ≥2 in the case of asymptomatic lone atrial fibrillation)..
- Hypertension that cannot be controlled by medications (>150/90 mmHg despite optimal medical therapy).
- Active, uncontrolled bacterial, fungal, or viral infection, including hepatitis B virus, hepatitis C virus, known human immunodeficiency virus (HIV), or acquired immunodeficiency syndrome (AIDS)-related illness.
- Active inflammatory gastrointestinal disease, uncontrolled chronic diarrhea, known diverticular disease, or previous gastric resection or lap band surgery. Gastroesophageal reflux disease is allowed except for if under treatment with proton pump inhibitors.
- Patients with Child Pugh C.
- Patients with electrolyte imbalances of hypokalemia, hypomagnesemia, and/or hypocalcemia.
- Patients with QTcF ≥470 msec.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Oral tablet(s) in combination with abiraterone and a corticosteroid.
ARV-110 oral tablets in combination with abiraterone and a corticosteroid administered daily in 28 day cycles.
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ARV-110 oral tablets in combination with abiraterone and a corticosteroid administered daily in 28 day cycles
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Incidence of dose limiting toxicities of ARV-110 in combination with abiraterone
Time Frame: 4 weeks
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Dose limiting toxicities in first 4 weeks of the study combination treatment characterized by type, frequency, severity (as graded by NCI CTCAE v 5.0), timing, seriousness, and relationship to study drug
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4 weeks
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Number of Patients with Adverse Events as a measure of safety and tolerability of ARV-110 in combination with abiraterone
Time Frame: 35 days after subject discontinues study treatment
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Adverse events as characterized by type, frequency, severity (as graded by NCI CTCAE version 5.0), timing, seriousness, and relationship to study drug combination
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35 days after subject discontinues study treatment
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Incidence of laboratory abnormalities as a measure of safety and tolerability of ARV-110 in combination with abiraterone
Time Frame: 35 days after subject discontinues study treatment
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Laboratory abnormalities as characterized by type, frequency, severity (as graded by NCI CTCAE v 5.0), and timing.
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35 days after subject discontinues study treatment
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Recommended Phase 2 dose (RP2D)/schedule for the combination
Time Frame: 4 weeks
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Dose limiting toxicities in first 4 weeks of the study combination treatment will be assessed to determine the dose of ARV-110 and abiraterone associated with acceptable safety and tolerability.
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4 weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 1, 2022
Primary Completion (Estimated)
July 30, 2024
Study Completion (Estimated)
December 31, 2025
Study Registration Dates
First Submitted
November 19, 2021
First Submitted That Met QC Criteria
December 15, 2021
First Posted (Actual)
January 4, 2022
Study Record Updates
Last Update Posted (Actual)
April 8, 2024
Last Update Submitted That Met QC Criteria
April 5, 2024
Last Verified
April 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ARV-110-mCRPC-103
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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