Spots Global Cancer Trial Database for Efficacy Evaluation of VERU-111 for mCRPC in Patients Who Have Failed at Least One Androgen Receptor Targeting Agent
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Trial Identification
Brief Title: Efficacy Evaluation of VERU-111 for mCRPC in Patients Who Have Failed at Least One Androgen Receptor Targeting Agent
Official Title: VERACITY - Randomized, Active-Controlled, Phase 3 Study of VERU-111 for the Treatment of Metastatic Castration-Resistant Prostate Cancer in Patients Who Have Failed Prior Treatment With at Least One Androgen Receptor Targeting Agent
Study ID: NCT04844749
Study Description
Brief Summary: To demonstrate the efficacy of VERU-111 (Sabizabulin) in the treatment of metastatic castration-resistant prostate cancer in patients who have failed prior treatment with at least one androgen receptor targeting agent as measured by radiographic progression-free survival.
Detailed Description: This study is a multicenter, randomized, open-label, active-control, efficacy and safety study of VERU-111 (Sabizabulin) for the treatment of metastatic castration-resistant prostate cancer in patients who have failed prior treatment with at least one androgen receptor targeting agent. Subjects will have failed treatment with at least one prior androgen receptor targeting agent and be eligible for treatment with an alternative androgen receptor targeting agent (as per the current standard of care for these patients). Subjects will be randomized in a 2:1 ratio to receive VERU-111 or Active Control (alternative androgen receptor targeting agent). Subjects in the VERU-111 treated group will receive VERU-111 32 mg per day orally with an option to reduce the dose to 26 mg per day based on tolerability to the 32 mg dose until radiographic progression (blinded independent central read) in observed. Subjects in the Control treated group will receive an alternative androgen receptor targeting agent with dose and dosing regimen defined in the FDA approved prescribing information until radiographic progression in observed. Randomization will be stratified by measurable disease vs. bone-only disease. A significant proportion (\>30%) of the patients randomized into the study will have measurable disease at baseline. Randomization will also be stratified by if the patient has failed one vs. more than one prior androgen targeting agent. The primary efficacy endpoint of the study will be radiographic progression free survival.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: MALE
Healthy Volunteers: No
Locations
Alaska Oncology and Hematology, LLC., Anchorage, Alaska, United States
Urology Associates of Southern Arizona, Tucson, Arizona, United States
Arizona Urology Specialists, Tucson, Arizona, United States
Tower Urology, Los Angeles, California, United States
University of California, Irvine, Orange, California, United States
West Coaster Center Urology, Oxnard, California, United States
San Bernardino Urological Associates, San Bernardino, California, United States
Genesis Resaerch, LLC, San Diego, California, United States
Genesis Healthcare Partners - Genesis Research Greater Los Angeles, Sherman Oaks, California, United States
Alicia Buenrostro, Torrance, California, United States
Colorado Urology, Golden, Colorado, United States
Universal Axon Clinical Research, Doral, Florida, United States
Demirra Hudge, Miami Beach, Florida, United States
Florida Urology Partners, LLC, Riverview, Florida, United States
Georgia Urology, Atlanta, Georgia, United States
Comprehensive Urologic Care, Lake Barrington, Illinois, United States
First Urology, PSC, Jeffersonville, Indiana, United States
MidAmerica Cancer Care, Merriam, Kansas, United States
Chesapeake Urology Research Associates, Baltimore, Maryland, United States
Michigan Institute of Urology, Troy, Michigan, United States
GU Research Network, LLC, Omaha, Nebraska, United States
Inpsira Medical Center Mullica Hill, Mullica Hill, New Jersey, United States
Ascension - Our Lady of Lourdes Memorial Hospital, Binghamton, New York, United States
Premier Medical Group of the Hudson Valley, Poughkeepsie, New York, United States
Associated Medical Professionals of NY, PLCC, Syracuse, New York, United States
Associated Urologists of North Carolina, Raleigh, North Carolina, United States
Cleveland Clinic, Cleveland, Ohio, United States
Clinical Research Solutions - Cleveland, Middleburg Heights, Ohio, United States
Oregon Urology Institute, Springfield, Oregon, United States
Centers for Advanced Urology, LLP MidLantic Urology, Bala-Cynwyd, Pennsylvania, United States
Carolina Urologic Research Center, Myrtle Beach, South Carolina, United States
Lexington Medical Center/ Lexington Oncology, West Columbia, South Carolina, United States
Urology Associates - Nashville, Nashville, Tennessee, United States
Houston Metro Urology, Houston, Texas, United States
Urology San Antonio P.A., San Antonio, Texas, United States
University of Virginia Health System, Charlottesville, Virginia, United States
Virginia Urology, Richmond, Virginia, United States
Urology of Virginia, PLLC, Virginia Beach, Virginia, United States
Cancer Care Northwest, Spokane Valley, Washington, United States
Spokane Urology P.S., Spokane, Washington, United States
Contact Details
Name: Barnette
Affiliation: Veru Inc.
Role: STUDY_CHAIR
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