- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05067140
A Study of ARV-766 Given by Mouth in Men With Metastatic Prostate Cancer
A Phase 1/2 Open-Label, Dose-Escalation and Cohort Expansion Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ARV-766 Monotherapy and in Combination With Abiraterone in Patients With Metastatic Prostate Cancer
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Contact
- Name: Arvinas Androgen Receptor, Inc.
- Phone Number: 475-345-3374
- Email: clinicaltrialsARV-766@arvinas.com
Study Locations
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California
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Duarte, California, United States, 91010
- Recruiting
- Clinical Trial Site
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Fresno, California, United States, 93720
- Recruiting
- Clinical Trial Site
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La Jolla, California, United States, 92037
- Recruiting
- Clinical Trial Site
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Orange, California, United States, 92868
- Recruiting
- Clinical Trial Site
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Santa Monica, California, United States, 90404
- Recruiting
- Clinical Trial Site
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Connecticut
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New Haven, Connecticut, United States, 06510
- Recruiting
- Clinical Trial Site
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District of Columbia
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Washington, District of Columbia, United States, 20007
- Not yet recruiting
- Clinical Trial Site
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Florida
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Lake Mary, Florida, United States, 32746
- Recruiting
- Clinical Trial Site
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Illinois
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Chicago, Illinois, United States, 60611
- Recruiting
- Clinical Trial Site
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Louisiana
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New Orleans, Louisiana, United States, 70112
- Recruiting
- Clinical Trial Site
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Maryland
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Baltimore, Maryland, United States, 21204
- Recruiting
- Clinical Trial Site
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Massachusetts
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Boston, Massachusetts, United States, 02114
- Recruiting
- Clinical Trial Site
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Michigan
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Detroit, Michigan, United States, 48201
- Recruiting
- Clinical Trial Site
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New York
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Buffalo, New York, United States, 14203
- Recruiting
- Clinical Trial Site
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New York, New York, United States, 10065
- Recruiting
- Clinical Trial Site
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19144
- Recruiting
- Clinical Trial Site
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Pittsburgh, Pennsylvania, United States, 15232
- Recruiting
- Clinical Trial Site
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South Carolina
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Myrtle Beach, South Carolina, United States, 29572
- Recruiting
- Clinical Trial Site
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Tennessee
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Nashville, Tennessee, United States, 37203
- Recruiting
- Clinical Trial Site
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Texas
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San Antonio, Texas, United States, 78229
- Recruiting
- Clinical Trial Site
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Virginia
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Charlottesville, Virginia, United States, 22908
- Recruiting
- Clinical Trial Site
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Fairfax, Virginia, United States, 22031
- Recruiting
- Clinical Trial Site
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Wisconsin
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Madison, Wisconsin, United States, 53705
- Recruiting
- Clinical Trial Site
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
Part A,B,C and D:
- Histological, pathological, or cytological confirmed diagnosis of adenocarcinoma of the prostate.
- Ongoing androgen deprivation therapy (ADT) with a gonadotropin releasing hormone analog or inhibitor, or orchiectomy (surgical or medical castration).
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
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
Part B:
- Participants must have received at least one but no more than three prior second generation anti-androgen agents (e.g., enzalutamide or abiraterone).
- Participants must have received no more than two prior chemotherapy regimens.
- Progressive mCRPC
Part C & D:
• Metastatic castration resistant or sensitive prostate cancer with radiographic evidence of metastatic disease
Exclusion Criteria:
Part A and B:
- Known symptomatic brain metastases requiring steroids (above physiologic replacement doses).
- Active inflammatory gastrointestinal disease, chronic diarrhea, known diverticular disease, or previous gastric resection or lap band surgery.
- Radiation therapy within 4 weeks of first dose of study drug or prior irradiation to >25% of the bone marrow.
- Receipt of an investigational drug(s) within 4 weeks prior to anticipated first dose
- Systemic anti-cancer therapy within 2 weeks of first dose of study drug (except agents to maintain castrate status). For bicalutamide, mitomycin C, or nitrosoureas the exclusion period must be 6 weeks and for abiraterone 4 weeks.
Part C and D
• Prior treatment with a second generation NHA
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Sequential Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: ARV-766
Oral tablets, once daily in 28 day cycles
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Part A: Daily oral dosages are determined by cohort review committee after initial starting dose cohort and each subsequent cohort completes 28 days of treatment. Part B: Oral tablet(s) once daily in 28 day cycles. |
Experimental: ARV-766 + Abiraterone
Oral tablets, once daily in 28 day cycles
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Part C: Daily oral combination dosages are determined by cohort review committee after initial starting dose cohort and each subsequent cohort completes 28 days of treatment. Part D: Combination administered once daily in 28 day cycles. Parts C&D: Participants will also receive concomitant corticosteroid and ADT therapy of investigator choice/patient preference
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Part A: Incidence of Dose Limiting Toxicities of ARV-766
Time Frame: 28 Days
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First Cycle Dose limiting toxicities characterized by type, frequency, severity (as graded by NCI CTCAE v 5.0), timing, seriousness, and relationship to study drug
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28 Days
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Part A: Number of Patients with Adverse Events as a measure of safety and tolerability of ARV-766
Time Frame: 28 Days
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Adverse events as characterized by type, frequency, severity (as graded by NCI CTCAE v 5.0), timing, seriousness, and relationship to study drug.
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28 Days
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Part A: Incidence of laboratory abnormalities as a measure of safety and tolerability of ARV-766
Time Frame: 28 Days
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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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28 Days
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Part B: To evaluate the clinical anti-tumor activity of ARV-766 in patients with mCRPC
Time Frame: 12 Weeks
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Evaluate PSA in patients with mCRPC in both dose groups
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12 Weeks
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Part C: Incidence of Dose Limiting Toxicities of ARV-766 / abiraterone combination
Time Frame: 28 Days
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First Cycle Dose limiting toxicities characterized by type, frequency, severity (as graded by NCI CTCAE v 5.0), timing, seriousness, and relationship to study drug
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28 Days
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Part C: Incidence of laboratory abnormalities as a measure of safety and tolerability of ARV-766 / abiraterone combination
Time Frame: 28 Days
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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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28 Days
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Part C: Number of Patients with Adverse Events as a measure of safety and tolerability of ARV-766 / abiraterone combination
Time Frame: 28 Days
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Adverse events as characterized by type, frequency, severity (as graded by NCI CTCAE v 5.0), timing, seriousness, and relationship to study drug.
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28 Days
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Part D: To evaluate the clinical anti-tumor activity of ARV-766 / abiraterone combination in patients with NHA-naïve mPC
Time Frame: 12 Weeks
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Evaluate PSA in patients with NHA-naïve mPC
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12 Weeks
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- ARV-766-mCRPC-101
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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