Trial of ARV-110 in Patients With Metastatic Castration Resistant Prostate Cancer
NCT ID: NCT03888612
Last Updated: 2025-04-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1/PHASE2
248 participants
INTERVENTIONAL
2019-03-01
2025-01-27
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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ARV-110
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
ARV-110
Part A: Daily oral dosages are predetermined by cohort review committee after the initial starting dose cohort after the first 28 days of treatment
Part B: Daily oral dosage and schedule at a recommended Phase 2 dose based on data from Part A
Interventions
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ARV-110
Part A: Daily oral dosages are predetermined by cohort review committee after the initial starting dose cohort after the first 28 days of treatment
Part B: Daily oral dosage and schedule at a recommended Phase 2 dose based on data from Part A
Eligibility Criteria
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Inclusion Criteria
* Patients must be male and at least 18 years of age at the time of signing the informed consent.
* Patients must present with histological, pathological, or cytological confirmed diagnosis of advanced or metastatic castration resistant adenocarcinoma of the prostate.
* Patients must have progressed on at least 2 prior approved systemic therapies for CRPC (at least one must be abiraterone or enzalutamide).
* Patients with progressive mCRPC
* Patients must have ongoing ADT with a gonadotropin releasing hormone analog or inhibitor, or orchiectomy (surgical or medical castration).
Part B:
* Patients must be male and at least 18 years of age at the time of signing the informed consent.
* Patients must present with histological, pathological, or cytological confirmed diagnosis of advanced or metastatic castration resistant adenocarcinoma of the prostate.
* Patients must have received at least one but no more than two prior second generation anti-androgen agents (e.g., enzalutamide or abiraterone) for CRPC.
* Patients must have received no more than one prior chemotherapy regimen in each of the following settings: castrate sensitive and castrate resistant prostate cancer.
* Patients must have ongoing ADT with a gonadotropin releasing hormone analog or inhibitor, or orchiectomy (surgical or medical castration).
Part B - Phase 2 Expansion Cohort Subgroup 4
* Patient has received only one prior AR second generation therapy (e.g., abiraterone or enzalutamide) either as treatment for CSPC or CRPC and no more than 1 regimen in CRPC setting.
* No prior chemotherapy
Exclusion Criteria
* Patients with known symptomatic brain metastases requiring steroids (above physiologic replacement doses)
* Major surgery (as defined by the Investigator) within 4 weeks of first dose of study drug.
* Radiation therapy within 4 weeks of first dose of study drug or prior irradiation to \>25% of the bone marrow. Palliative radiation for the alleviation of pain due to bone metastasis will be allowed during the study
* Systemic anti cancer therapy within 2 weeks of first dose of study drug (6 weeks for bicalutamide, mitomycin C, or nitrosoureas and 4 weeks for abiraterone). Patients are ineligible if they received any other type of anti cancer agent (except agents to maintain castrate status) within 2 weeks before first dose of study drug.
Part B:
* Patients with known symptomatic brain metastases requiring steroids (above physiologic replacement doses)
* Major surgery (as defined by the Investigator) within 4 weeks of first dose of study drug.
* Radiation therapy within 4 weeks of first dose of study drug or prior irradiation to \>25% of the bone marrow. Palliative radiation for the alleviation of pain due to bone metastasis will be allowed during the study
* Systemic anti cancer therapy within 2 weeks of first dose of study drug (6 weeks for bicalutamide, mitomycin C, or nitrosoureas and 4 weeks for abiraterone). Patients are ineligible if they received any other type of anti cancer agent (except agents to maintain castrate status) within 2 weeks before first dose of study drug.
18 Years
MALE
No
Sponsors
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Arvinas Inc.
INDUSTRY
Responsible Party
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Locations
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Clinical Trial Site
Los Angeles, California, United States
Clinical Trial Site
Orange, California, United States
Clinical Trial Site
San Francisco, California, United States
Clinical Trial Site
New Haven, Connecticut, United States
Clinical Trial Site
Altamonte Springs, Florida, United States
Clinical Trial Site
Bonita Springs, Florida, United States
Clinical Trial Site
Bradenton, Florida, United States
Clinical Trial Site
Brandon, Florida, United States
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Cape Coral, Florida, United States
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Clearwater, Florida, United States
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Daytona Beach, Florida, United States
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Fleming Island, Florida, United States
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Fort Myers, Florida, United States
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Gainesville, Florida, United States
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Largo, Florida, United States
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Lecanto, Florida, United States
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Naples, Florida, United States
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New Port Richey, Florida, United States
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Ocala, Florida, United States
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Orange City, Florida, United States
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Orlando, Florida, United States
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Port Charlotte, Florida, United States
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Sarasota, Florida, United States
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Spring Hill, Florida, United States
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St. Petersburg, Florida, United States
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Stuart, Florida, United States
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Tampa, Florida, United States
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Tavares, Florida, United States
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The Villages, Florida, United States
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Venice, Florida, United States
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Vero Beach, Florida, United States
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Wellington, Florida, United States
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West Palm Beach, Florida, United States
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Winter Park, Florida, United States
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Chicago, Illinois, United States
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New Orleans, Louisiana, United States
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Boston, Massachusetts, United States
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Detroit, Michigan, United States
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Omaha, Nebraska, United States
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Las Vegas, Nevada, United States
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New York, New York, United States
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Portland, Oregon, United States
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Dickson, Tennessee, United States
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Franklin, Tennessee, United States
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Gallatin, Tennessee, United States
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Hendersonville, Tennessee, United States
Clinical Trial Site
Hermitage, Tennessee, United States
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Lebanon, Tennessee, United States
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Murfreesboro, Tennessee, United States
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Nashville, Tennessee, United States
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Shelbyville, Tennessee, United States
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Smyrna, Tennessee, United States
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Salt Lake City, Utah, United States
Clinical Trial Site
Charlottesville, Virginia, United States
Countries
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References
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Snyder LB, Neklesa TK, Willard RR, Gordon DA, Pizzano J, Vitale N, Robling K, Dorso MA, Moghrabi W, Landrette S, Gedrich R, Lee SH, Taylor ICA, Houston JG. Preclinical Evaluation of Bavdegalutamide (ARV-110), a Novel PROteolysis TArgeting Chimera Androgen Receptor Degrader. Mol Cancer Ther. 2025 Apr 2;24(4):511-522. doi: 10.1158/1535-7163.MCT-23-0655.
Other Identifiers
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ARV-110-mCRPC-101
Identifier Type: -
Identifier Source: org_study_id
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