Prostate Cancer Clinical Trial

Efficacy Evaluation of VERU-111 for mCRPC in Patients Who Have Failed at Least One Androgen Receptor Targeting Agent

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.

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Full 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.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Provide informed consent.
Be able to communicate effectively with the study personnel.
Aged ≥18 years.
Histological or cytologic proof of adenocarcinoma of the prostate not including the diagnosis of small cell carcinoma of the prostate of neuroendocrine pathology.
Radiographic evidence of metastatic disease at baseline by CT scan, or MRI and bone scan, with confirmation of measurable disease by RECIST 1.1 and/or identifiable discrete bone metastases by PCWG3.
Known castration resistant prostate cancer, defined according to PCWG3 criteria.
Have received at least one androgen receptor targeting agent (e.g. abiraterone, enzalutamide, darolutamide, or apalutamide).
Subjects who have metastatic castration resistant prostate cancer that have maintained or have previously been treated with ADT (while on-study, patients must receive continuous ADT. Either chemical or surgical castration by bilateral orchiectomy is acceptable) and have failed prior treatment with at least one androgen receptor targeting agent (e.g. abiraterone, enzalutamide, darolutamide, or apalutamide) defined as:
Serum PSA progression of two consecutive increases in PSA over a previous reference value within 6 months of first study treatment, each measurement at least 2 weeks apart. Or
Documented bone lesions by the appearance of two or more new lesions on bone scintigraphy or bi-dimensionally-measurable soft tissue metastatic lesion assessed by CT or MRI.
Treatment with an alternative androgen receptor targeting agent is a reasonable next line of therapy.
Absolute PSA ≥2.0 ng/ml at screening.
ECOG performance status <2.
Participants must have normal organ and bone marrow function measured within 30 days prior to administration of study treatment as defined below:
Hemoglobin ≥9.0 g/dL with no blood transfusion in the past 30 days
Creatinine clearance ≥60 mL/min (using Cockcroft-Gault equation)
Absolute neutrophil count (ANC) ≥1.5 x 109/L
Platelet count ≥100 x 109/L
Total bilirubin ≤ upper limit of normal (ULN) (or <2.5 x ULN for patients with known Gilberts disease)
Aspartate aminotransferase (AST) (Serum Glutamic Oxaloacetic Transaminase (SGOT))/Alanine aminotransferase (ALT) (Serum Glutamic Pyruvate Transaminase (SGPT)) ≤2.5 x ULN. NOTE: Patients with elevations in bilirubin, AST, or ALT should be thoroughly evaluated for the etiology of this abnormality prior to entry and patients with evidence of viral infection should be excluded. Patients with chronic renal stent and stable creatinine elevation can be included in the study with written documentation from the PI.
Participants must have a life expectancy >3 months.
Subjects must agree to use acceptable methods of contraception:
If the study subject's partner could become pregnant, use acceptable methods of contraception from the time of the first administration of study medication until 6months following administration of the last dose of study medication. Acceptable methods of contraception are as follows: Condom with spermicidal foam/gel/film/cream/suppository [i.e.,barrier method of contraception], surgical sterilization (vasectomy with documentation of azospermia) and a barrier method {condom used with spermicidal foam/gel/film/cream/suppository}, the female partner uses oral contraceptives (combination estrogen/progesterone pills), injectable progesterone or subdermal implants and a barrier method (condom used with spermicidal foam/gel/film/cream/suppository).
If female partner of a study subject has undergone documented tubal ligation (female sterilization), a barrier method (condom used with spermicidal foam/gel/film/cream/suppository)should also be used.-If female partner of a study subject has undergone documented placement of an intrauterine device (IUD) or intrauterine system (IUS),a barrier method (condom with spermicidal foam/gel/film/cream/suppository)should also be used.
Other than metastatic prostate cancer, no evidence (within 5 years) of prior malignancies (except successfully treated basal cell or squamous cell carcinoma of the skin or other cancers treated with curative intent >3 years prior).
Participants must agree to refrain from prolonged exposure to the sun or agree to use at least SPF 50 on all exposed skin and protective clothing during prolonged sun exposure throughout participation in this study and/or treatment with VERU- 111.
Subject is willing to comply with the requirements of the protocol through the end of the study.

Exclusion Criteria:

Known hypersensitivity or allergy to colchicine.
Histologic identification of small cell carcinoma of the prostate or neuroendocrine pathology in either biopsy or prostatectomy tissue.
A bone scan with evidence of superscan or superscan phenomenon, defined as:
Uptake throughout the axial skeleton and proximal appendicular skeleton, often somewhat heterogeneous, or,
Symmetrically intense and diffuse radiotracer uptake in the skeleton with absent or diminished visualization of the genitourinary system and soft tissues, or,
Defined in the bone scan report as a superscan or superscan phenomenon. NOTE: Medical Monitor should be consulted prior to screening of a patient if a superscan or superscan phenomenon is suspected or possible, but undetermined by any of the above definitions.
Has received external-beam radiotherapy within the last 2 weeks prior to start of study treatment.
Patients with a QT interval corrected by Fridericia's formula of >480 ms.
Patients receiving full dose warfarin therapy are not eligible for study.
Patients with prior history of a thromboembolic event within the last 6 months.
Participation in another clinical study with an investigational product during the last 6 months prior to randomization into this study.
Patients should be excluded if they have had prior systemic treatment with prior taxane chemotherapies (for greater than 2 cycles) for advanced prostate cancer. Patient can have up to 2 cycles of prior taxane chemotherapy greater than one year prior to randomization and remain eligible for inclusion in this study. Taxane exposure in the adjuvant or neoadjuvant setting is allowed (maximum of 6 cycles).
Any treatment modalities involving major surgery within 4weeks prior to the start of study treatment.
Patients are excluded if they have known brain metastases or leptomeningeal metastases.
Patients should be excluded if they have a positive test for hepatitis B virus surface antigen (HBV sAg) or hepatitis C virus ribonucleic acid (HCV antibody) indicating acute or chronic infection.
Has imminent or established spinal cord compression based on clinical findings and/or MRI.
Any other serious illness or medical condition that would, in the opinion of the investigator, make this protocol unreasonably hazardous. Active infections discovered during screening period must be treated and controlled before patient is dosed with VERU-111.
Persistent toxicities (>Common Terminology Criteria for Adverse Event (CTCAE) grade 2) caused by previous cancer therapy, excluding alopecia.
Poor medical risk due to a serious, uncontrolled medical disorder, non-malignant systemic disease or active, uncontrolled infection. Examples include, but are not limited to, uncontrolled ventricular arrhythmia, recent (within 6 months) myocardial infarction, uncontrolled major seizure disorder, extensive interstitial bilateral lung disease, or any psychiatric disorder that prohibits obtaining informed consent.
Total bilirubin levels > 1.5 x ULN (>2.5 x ULN in patients with known Gilbert's disease).
AST and/or ALT levels >2.5xULN or AST and/or ALT levels >1.5xULN WITH concomitant alkaline phosphatase levels >2.5xULN.

Study is for people with:

Prostate Cancer

Phase:

Phase 3

Estimated Enrollment:

245

Study ID:

NCT04844749

Recruitment Status:

Recruiting

Sponsor:

Veru Inc.

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There are 44 Locations for this study

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Alaska Oncology and Hematology, LLC.
Anchorage Alaska, 99508, United States More Info
Ashli Meek
Contact
907-257-9851
[email protected]
Steven Lui
Principal Investigator
Arizona Urology Specialists - Glendale- Arrowhead
Glendale Arizona, 85306, United States
Urology Associates of Southern Arizona
Tucson Arizona, 85715, United States More Info
Christina Montijo
Contact
520-351-5582
[email protected]
Susan Kalota
Principal Investigator
Arizona Urology Specialists
Tucson Arizona, 85745, United States More Info
Melanie Chavez
Contact
520-784-7087
[email protected]
Lucy Pena
Contact
520-784-7087
[email protected]
Kalpesh Patel
Principal Investigator
Arkansas Urology
Little Rock Arkansas, 72211, United States
Tower Urology
Los Angeles California, 90048, United States More Info
Terry Williams
Contact
310-854-9898
[email protected]
David Josephson
Principal Investigator
University of California, Irvine
Orange California, 92868, United States More Info
Phillip Duffy
Contact
714-456-6801
[email protected]
Edward Uchio
Principal Investigator
West Coaster Center Urology
Oxnard California, 93036, United States More Info
Lorenzo Aguirre
Contact
520-351-5583
[email protected]
Sherif Aboseif
Principal Investigator
San Bernardino Urological Associates
San Bernardino California, 92506, United States More Info
Roxie Miller
Contact
Franklin Chu
Principal Investigator
Genesis Resaerch, LLC
San Diego California, 92123, United States More Info
Sonia Romo
Contact
858-430-1101
[email protected]
Paul Dato
Principal Investigator
Genesis Healthcare Partners - Genesis Research Greater Los Angeles
Sherman Oaks California, 91411, United States More Info
Chemyn Cortez
Contact
424-212-4593
[email protected]
Richard David
Principal Investigator
Alicia Buenrostro
Torrance California, 90505, United States More Info
Chemyn Cortez
Contact
424-212-4593
[email protected]
Kambiz Dardashti
Principal Investigator
Colorado Urology
Golden Colorado, 80401, United States More Info
Jennifer Quinn
Contact
303-607-3424
[email protected]
Deborah Aggers
Contact
303-996-9649
[email protected]
David Cahn
Principal Investigator
Universal Axon Clinical Research
Doral Florida, 33166, United States More Info
Yassel Hernandez
Contact
305-677-9267
[email protected])
Luis Martinez
Principal Investigator
Demirra Hudge
Miami Beach Florida, 33140, United States More Info
Madeline Foust
Contact
305-674-2625
[email protected]
Mike Cusnir
Principal Investigator
Florida Urology Partners, LLC
Riverview Florida, 33578, United States More Info
Haydy Rojas
Contact
813-981-3931
[email protected]
Alexander Engelman
Principal Investigator
Georgia Urology
Atlanta Georgia, 30309, United States More Info
Joseph Festa
Contact
678-344-8900
[email protected]
Marci Dudley
Contact
470-589-5600
[email protected]
Vahan Kassabian
Principal Investigator
Comprehensive Urologic Care
Lake Barrington Illinois, 60010, United States More Info
Theresa Campos
Contact
847-852-7906
[email protected]
Ning Wu
Principal Investigator
First Urology, PSC
Jeffersonville Indiana, 47130, United States More Info
Christina Nessel
Contact
812-206-8162
[email protected]
James Bailen
Principal Investigator
MidAmerica Cancer Care
Merriam Kansas, 66204, United States More Info
Pamela McCann
Contact
[email protected]
Jaswinder Singh
Principal Investigator
Regional Urology, LLC
Shreveport Louisiana, 71106, United States
Chesapeake Urology Research Associates
Baltimore Maryland, 21204, United States More Info
Diane Shmul
Contact
443-231-1678
[email protected]
Ronald Tutrone
Principal Investigator
Michigan Institute of Urology
Troy Michigan, 48084, United States More Info
Shachi Pradhan
Contact
248-786-0467
[email protected]
Danielle Osterhout
Contact
248-786-0467
[email protected]
Kenneth Kernen
Principal Investigator
GU Research Network, LLC
Omaha Nebraska, 68130, United States More Info
Laura Frank
Contact
402-991-8468
[email protected]
Luke Nordquist
Principal Investigator
Inpsira Medical Center Mullica Hill
Mullica Hill New Jersey, 08062, United States More Info
Sami Abate
Contact
856-641-7526
[email protected]
Erev Tubb
Principal Investigator
Inspira Medical Center
Vineland New Jersey, 08360, United States More Info
Mylene Go
Principal Investigator
Ascension - Our Lady of Lourdes Memorial Hospital
Binghamton New York, 13905, United States More Info
Cynthia Campo
Contact
607-798-5718
[email protected]
Stacie Hansen
Contact
607-798-5254
[email protected]
Kathleen McGinley
Principal Investigator
Premier Medical Group of the Hudson Valley
Poughkeepsie New York, 12603, United States More Info
Lisa Gray
Contact
845-437-5010
[email protected]
Evan Goldfischer
Principal Investigator
Associated Medical Professionals of NY, PLCC
Syracuse New York, 13210, United States More Info
Dante Whitmire
Contact
315-478-4185
[email protected]
Christopher Pieczonka
Principal Investigator
Associated Urologists of North Carolina
Raleigh North Carolina, 27612, United States More Info
Kip Moffett
Contact
919-390-7368
[email protected]
Mark Jalkut
Principal Investigator
Cleveland Clinic
Cleveland Ohio, 44195, United States More Info
Ireland Flores Rae
Contact
216-316-4162
[email protected]
Moshe Ornstein
Principal Investigator
Clinical Research Solutions - Cleveland
Middleburg Heights Ohio, 44130, United States More Info
Jennifer Kalapis
Contact
440-340-9010
[email protected]
Lawrence Gervasi
Principal Investigator
Oregon Urology Institute
Springfield Oregon, 97477, United States More Info
Renee Podesta
Contact
541-284-5508
[email protected]
Stephanie Kerns
Contact
541-284-5508
[email protected]
Bryan Mehlhaff
Principal Investigator
Centers for Advanced Urology, LLP MidLantic Urology
Bala-Cynwyd Pennsylvania, 19004, United States More Info
Brittny Goodell
Contact
610-667-0458
[email protected]
Laurence Belkoff
Principal Investigator
Carolina Urologic Research Center
Myrtle Beach South Carolina, 29572, United States More Info
Kate Valipour
Contact
843-449-1010
[email protected]
Neal Shore
Principal Investigator
Lexington Medical Center/ Lexington Oncology
West Columbia South Carolina, 29169, United States More Info
Taylor Knight
Contact
803-794-7511
[email protected]
Selena Lollar
Contact
803-794-7511
[email protected]
Steven Madden
Principal Investigator
Urology Associates - Nashville
Nashville Tennessee, 37209, United States More Info
Micki Porcello
Contact
615-622-5017
[email protected]
Mercedes Bruce
Contact
[email protected]
David Morris
Principal Investigator
Houston Metro Urology
Houston Texas, 77027, United States More Info
Lilibeth Aparicio
Contact
713-351-0630
[email protected]
Zvi Schiffman
Principal Investigator
Urology San Antonio P.A.
San Antonio Texas, 78258, United States More Info
Rebecca Larson
Contact
210-617-4116
[email protected]
Daniel Saltzstein
Principal Investigator
University of Virginia Health System
Charlottesville Virginia, 22908, United States More Info
Mary Claros
Contact
434-297-7782
[email protected]
Alexandra Cash
Contact
434-297-7782
[email protected]
Michael Devitt
Principal Investigator
Virginia Urology
Richmond Virginia, 23230, United States More Info
Brittany Quigley
Contact
804-288-2785
[email protected]
Eugene Kramolowsky
Principal Investigator
Urology of Virginia, PLLC
Virginia Beach Virginia, 23462, United States More Info
James Knight
Contact
757-452-3463
[email protected]
Robert Given
Principal Investigator
Cancer Care Northwest
Spokane Valley Washington, 99261, United States More Info
Julie Skarsvog
Contact
509-228-1693
[email protected]
Maury Blitman
Principal Investigator
Spokane Urology P.S.
Spokane Washington, 99202, United States More Info
Amy Bardwell
Contact
509-747-3147
[email protected]
Raymond Lance
Principal Investigator

How clear is this clinincal trial information?

Study is for people with:

Prostate Cancer

Phase:

Phase 3

Estimated Enrollment:

245

Study ID:

NCT04844749

Recruitment Status:

Recruiting

Sponsor:


Veru Inc.

How clear is this clinincal trial information?

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