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Metastatic Castration-resistant Prostate CancerPhase 3VERACITYNCT04844749

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

A Phase 3 study testing VERU-111 and Enzalutamide, Abiraterone in people with Metastatic Castration-resistant Prostate Cancer and Androgen Resistant Prostatic Cancer, run by Veru Inc. at 40 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 100 years, men only
What is being tested?
VERU-111 and Enzalutamide, Abiraterone
Could I receive a placebo?
No, everyone receives an active treatment
How many people
105 participants
Where
40 sitesUnited States
Study dates
24 Jun 2021to 4 May 2023
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 100 years
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

40 sites in 1 country.

40 sites in 1 country

United States40 sites

  • Alaska Oncology and Hematology, LLC.

    Anchorage, Alaska, 99508

  • Georgia Urology

    Atlanta, Georgia, 30309

  • Centers for Advanced Urology, LLP MidLantic Urology

    Bala-Cynwyd, Pennsylvania, 19004

  • Chesapeake Urology Research Associates

    Baltimore, Maryland, 21204

  • Ascension - Our Lady of Lourdes Memorial Hospital

    Binghamton, New York, 13905

  • University of Virginia Health System

    Charlottesville, Virginia, 22908

  • Cleveland Clinic

    Cleveland, Ohio, 44195

  • Universal Axon Clinical Research

    Doral, Florida, 33166

  • Colorado Urology

    Golden, Colorado, 80401

  • Houston Metro Urology

    Houston, Texas, 77027

  • First Urology, PSC

    Jeffersonville, Indiana, 47130

  • Comprehensive Urologic Care

    Lake Barrington, Illinois, 60010

  • Tower Urology

    Los Angeles, California, 90048

  • MidAmerica Cancer Care

    Merriam, Kansas, 66204

  • Demirra Hudge

    Miami Beach, Florida, 33140

  • Clinical Research Solutions - Cleveland

    Middleburg Heights, Ohio, 44130

  • Inpsira Medical Center Mullica Hill

    Mullica Hill, New Jersey, 08062

  • Carolina Urologic Research Center

    Myrtle Beach, South Carolina, 29572

  • Urology Associates - Nashville

    Nashville, Tennessee, 37209

  • GU Research Network, LLC

    Omaha, Nebraska, 68130

  • University of California, Irvine

    Orange, California, 92868

  • West Coaster Center Urology

    Oxnard, California, 93036

  • Premier Medical Group of the Hudson Valley

    Poughkeepsie, New York, 12603

  • Associated Urologists of North Carolina

    Raleigh, North Carolina, 27612

  • Virginia Urology

    Richmond, Virginia, 23230

  • Florida Urology Partners, LLC

    Riverview, Florida, 33578

  • Urology San Antonio P.A.

    San Antonio, Texas, 78258

  • San Bernardino Urological Associates

    San Bernardino, California, 92506

  • Genesis Resaerch, LLC

    San Diego, California, 92123

  • Genesis Healthcare Partners - Genesis Research Greater Los Angeles

    Sherman Oaks, California, 91411

  • Spokane Urology P.S.

    Spokane, Washington, 99202

  • Cancer Care Northwest

    Spokane Valley, Washington, 99216

  • Oregon Urology Institute

    Springfield, Oregon, 97477

  • Associated Medical Professionals of NY, PLCC

    Syracuse, New York, 13210

  • Alicia Buenrostro

    Torrance, California, 90505

  • Michigan Institute of Urology

    Troy, Michigan, 48084

  • Urology Associates of Southern Arizona

    Tucson, Arizona, 85715

  • Arizona Urology Specialists

    Tucson, Arizona, 85745

  • Urology of Virginia, PLLC

    Virginia Beach, Virginia, 23462

  • Lexington Medical Center/ Lexington Oncology

    West Columbia, South Carolina, 29169

Other trials in United States

About this study

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

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.

Read the 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.

Being tested
VERU-111, Enzalutamide, Abiraterone
Medical subject headings
Prostatic Neoplasms, Castration-Resistant

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • VERU-111Drug

    Also called Sabizabulin

    Based on the safety and antitumor activity of VERU-111 in the Phase 1b/2 clinical study, VERU-111 is initiating this Phase 3 clinical 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

  • Enzalutamide, AbirateroneDrug

    Also called XTANDI, Zytiga

    Enzalutamide and abiraterone were chosen as active comparators are both are FDA approved for the treatment of metastatic castration resistant prostate cancer

Study groups in NCT04844749
Study groupRoleWhat they receive
Either VERU-111 32mg or 26mg dose will be supplied as capsules 1 orally once a dayExperimental32mg of VERU-111 26mg of VERU-11
Receives: Drug: VERU-111
Active control alternative androgen receptor targeting agentActive comparatorThe alternative androgen receptor targeting agent will be administered according to the dosing instructions in the current product prescribing information.
Receives: Drug: Enzalutamide, Abiraterone

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Efficacy of VERU-111 in the treatment of metastatic castration-resistant prostate cancer in patients who have failed prior treatment with at least one androgen receptor targeting agent

    Radiographic progression-free survival (rPFS) centrally read, which is death or tumor progression as defined by RECIST 1.1 (soft tissue) and PCWG3 (bone).

    Measured: 360 days

Secondary outcomes (1)

  1. Overall Survival

    Overall survival (OS) will be an assessment of time from randomization into the study to all-cause mortality. The analysis will be performed similarly to the primary endpoint.

    Measured: 360 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Apr 2021
  2. Study start24 Jun 2021
  3. Primary completion4 May 2023
  4. Study completion4 May 2023

Why it stopped: Administrative reasons

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
This randomized, open-label, active-control clinical study consists of two treatment arms:VERU-111 (Sabizabulin) treated group, and Control treated group. Subjects will be randomized in a 2:1 fashion.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
105 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04844749
Sponsor's protocol ID
V3011102
Acronym
VERACITY
Status last verified
Feb 2024
First submitted
9 Apr 2021
Last updated
5 Feb 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing VERU-111 and Enzalutamide, Abiraterone in people with Metastatic Castration-resistant Prostate Cancer and Androgen Resistant Prostatic Cancer, run by Veru Inc. at 40 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 27 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 5 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 40 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Administrative reasons). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Efficacy of VERU-111 in the treatment of metastatic castration-resistant prostate cancer in patients who have failed prior treatment with at least one androgen receptor targeting agent (time frame: 360 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04844749.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2024.

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