A Study of ARV-766 Given by Mouth in Men With Metastatic Prostate Cancer
NCT ID: NCT05067140
Last Updated: 2025-03-17
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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ACTIVE_NOT_RECRUITING
PHASE1/PHASE2
152 participants
INTERVENTIONAL
2021-09-02
2027-05-25
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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ARV-766
Oral tablets, once daily in 28 day cycles
ARV-766 Part A&B
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.
ARV-766 + Abiraterone
Oral tablets, once daily in 28 day cycles
ARV-766 + Abiraterone Part C&D
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
Interventions
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ARV-766 Part A&B
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.
ARV-766 + Abiraterone Part C&D
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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
MALE
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
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Clinical Trial Site
Duarte, California, United States
Clinical Trial Site
Fresno, California, United States
Clinical Trial Site
La Jolla, California, United States
Clinical Trial Site
Orange, California, United States
Clinical Trial Site
Santa Monica, California, United States
Clinical Trial Site
New Haven, Connecticut, United States
Clinical Trial Site
Washington D.C., District of Columbia, United States
Clinical Trial Site
Lake Mary, Florida, United States
Clinical Trial Site
Chicago, Illinois, United States
Clinical Trial Site
New Orleans, Louisiana, United States
Clinical Trial Site
Baltimore, Maryland, United States
Clinical Trial Site
Boston, Massachusetts, United States
Clinical Trial Site
Detroit, Michigan, United States
Clinical Trial Site
Buffalo, New York, United States
Clinical Trial Site
New York, New York, United States
Clinical Trial Site
Philadelphia, Pennsylvania, United States
Clinical Trial Site
Pittsburgh, Pennsylvania, United States
Clinical Trial Site
Myrtle Beach, South Carolina, United States
Clinical Trial Site
Nashville, Tennessee, United States
Clinical Trial Site
San Antonio, Texas, United States
Clinical Trial Site
Charlottesville, Virginia, United States
Clinical Trial Site
Fairfax, Virginia, United States
Clinical Trial Site
Madison, Wisconsin, United States
Countries
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Other Identifiers
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ARV-766-mCRPC-101
Identifier Type: OTHER
Identifier Source: secondary_id
CJSB462A12101
Identifier Type: -
Identifier Source: org_study_id
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