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A Study of ARV-766 Given by Mouth in Men With Metastatic Prostate Cancer
Study Purpose
A Phase 1/2 study to evaluate the safety and efficacy of ARV-766 given by mouth alone or in combination with abiraterone in men with metastatic prostate cancer.
Recruitment Criteria
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.
An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.
Searching Both is inclusive of interventional and observational studies.
Inclusion Criteria:
Part A,B,C and D:- - Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Part A:- - Progressive mCRPC.
Part B:- - Progressive mCRPC.
Part C & D: • Metastatic castration resistant or sensitive prostate cancer with radiographic evidence of metastatic disease.Exclusion Criteria:
Part A and B:- - 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 NHATrial Details
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.
Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.
Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.
Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
The person who is responsible for the scientific and technical direction of the entire clinical study.
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
The disease, disorder, syndrome, illness, or injury that is being studied.
Arms
Experimental: ARV-766
Oral tablets, once daily in 28 day cycles
Experimental: ARV-766 + Abiraterone
Oral tablets, once daily in 28 day cycles
Interventions
Drug: - 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.
Drug: - 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
Contact a Trial Team
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Duarte, California, 91010
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Fresno, California, 93720
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La Jolla, California, 92037
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Orange, California, 92868
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Santa Monica, California, 90404
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New Haven, Connecticut, 06510
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Washington, District of Columbia, 20007
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Boston, Massachusetts, 02114
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Detroit, Michigan, 48201
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Buffalo, New York, 14203
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New York, New York, 10065
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Philadelphia, Pennsylvania, 19144
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Pittsburgh, Pennsylvania, 15232
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Myrtle Beach, South Carolina, 29572
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Nashville, Tennessee, 37203
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San Antonio, Texas, 78229
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Charlottesville, Virginia, 22908
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Fairfax, Virginia, 22031
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Madison, Wisconsin, 53705
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