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Metastatic Breast CancerPhase 2NCT05079360

Efficacy Evaluation of Sabizabulin Monotherapy Versus Active Control for Treatment of ER+HER2- Metastatic Breast Cancer

A Phase 2 study testing Sabizabulin and Exemestane monotherapy, exemestane plus everolimus, or selective estrogen receptor modulator in people with Metastatic Breast Cancer, run by Veru Inc. at 26 sites in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

To demonstrate the efficacy of sabizabulin in the treatment of ER+HER2- metastatic breast cancer (MBC) as measured by progression free survival (PFS) by RECIST v1.1. Read more about this study

Who is it for?
Ages 18 to 100 years
Conditions the study is for
Metastatic Breast Cancer
What is being tested?
Sabizabulin and Exemestane monotherapy, exemestane plus everolimus, or selective estrogen receptor modulator
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
26 sitesUnited States
Study dates
15 Mar 2023to 26 May 2024
Phase
Phase 2
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
  • All sexes
  • 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
  • For Female Subjects Menopausal status
  • Be postmenopausal as defined by the National Comprehensive Cancer Network as either:
  • Age ≥55 years and one year or more of amenorrhea
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  • Age <55 years and one year or more of amenorrhea, with an estradiol assay <20 pg/mL
  • Age <55 years and surgical menopause with bilateral oophorectomy
  • Be premenopausal or perimenopausal with a negative urine pregnancy test.
  • If subject is of child bearing potential, the subject must agree to use acceptable methods of contraception:
  • If female study participant could become pregnant, use acceptable methods of contraception from the time of the first administration of study medication until 6 months 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 of male partner (vasectomy with documentation of azoospermia) and a barrier method {condom used with spermicidal foam/gel/film/cream/suppository}
  • If female study participant 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 study participant 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
  • For Male Subjects
  • Subject 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 6 months 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 azoospermia) 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
  • For premenopausal and perimenopausal women where exemestane monotherapy or exemestane plus everolimus is chosen as the active control treatment or the patient is randomized to receive sabizabulin, the patient must be already on ovarian suppression or be candidates for this treatment: e.g., luteinizing hormone release hormone agonist or ovariectomy
  • Eastern Cooperative Oncology Group (ECOG) performance status of ≤2
  • Documented evidence of ER+/HER2- metastatic breast cancer (NOTE: patients HER2+ metastatic breast cancer are excluded from participation in this study)
  • Measurable disease is required as per RECIST 1.1 as confirmed by BICR (NOTE: Bone only metastatic disease is acceptable but requires a measurable component)
  • Received a nonsteroidal AI (monotherapy or combination therapy) either for adjuvant or metastatic breast cancer and a SERD, such as fulvestrant (monotherapy or combination therapy) for MBC; at least one of the non-steroidal AI or SERD must have been given in combination with a CDK 4/6 inhibitor.
  • Previously responded (without disease progression for at least 6 months) to one of the following treatments: SERD monotherapy or SERD plus CDK 4/6 inhibitor or nonsteroidal aromatase inhibitor monotherapy or nonsteroidal aromatase inhibitor plus CDK 4/6 inhibitor for metastatic breast cancer.
  • Subject is willing to comply with the requirements of the protocol through the end of the study

Who cannot join

  • Women of childbearing potential or fertile men with a female partner of childbearing potential not willing to use effective contraception during the study and 6 months after last dose of study drug for the women of childbearing potential participating in the study and for 3 months after last dose of study drug in fertile men with a female partner of childbearing potential.
  • Known hypersensitivity or allergy to sabizabulin or colchicine
  • Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >2.5 X upper limit of normal (ULN) or total bilirubin >ULN (an elevated total bilirubin up to 1.5 X ULN attributed to a previously confirmed diagnosis of Gilbert's disease is acceptable if all other eligibility criteria are met). In patients with documented metastases to the liver, the limits for inclusion are ALT or AST >5.0 X ULN or total bilirubin >1.5 X ULN.
  • Patients with biliary catheter
  • Creatinine clearance < 60 mL/min as measured using the Cockcoft Gault formula (patients with mild and moderate renal failure are not excluded from participation in this study)
  • QT interval corrected by Fridericia's formulation >480 ms
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  • Patients with history of Tosade de Pointe
  • Patients taking QT-prolonging drugs
  • Previously received >1 course of systemic chemotherapy (not including immunotherapies or targeted therapies) for the treatment of metastatic breast cancer.
  • NOTE: A course of systemic chemotherapy is defined as a line of prior chemotherapy.
  • Chemotherapy received in the neoadjuvant or adjuvant setting will not count as a prior line of chemotherapy.
  • Subjects with radiographic evidence of central nervous system (CNS) metastases as assessed by CT or MRI that are not well-controlled (symptomatic or requiring control with continuous corticosteroid therapy [e.g., dexamethasone]) NOTE: Subjects with CNS metastases are permitted to participate in the study if the CNS metastases are medically well-controlled and stable for at least 30 days after receiving local therapy (irradiation, surgery, etc.)
  • Radiotherapy within 14 days prior to randomization except in case of localized radiotherapy for analgesic purpose or for lytic lesions at risk of fracture, which can then be completed within 7 days prior to randomization. Subjects must have recovered from radiotherapy toxicities prior to randomization
  • Any comorbid disease or condition (medical or surgical) which might compromise the hematologic, cardiovascular, endocrine, pulmonary, severe renal impairment, gastrointestinal, hepatic, or central nervous system; or other conditions that may interfere with the absorption, distribution, metabolism or excretion of study drug, or would place the subject at increased risk
  • Treatment with any investigational product within < 5 half-lives for each individual investigational product OR within 30 days prior to randomization whichever is shorter.
  • Major surgery within 30 days prior to randomization
  • Treatment with testosterone, methyltestosterone, oxandrolone (Oxandrin®), oxymetholone, danazol, fluoxymesterone (Halotestin®), testosterone-like agents (such as dehydroepiandrosterone, androstenedione, and other androgenic compounds, including herbals), or antiandrogens (enzalutamide, abiraterone, bicalutamide, apalutamide, or darolutamide). Previous therapy with testosterone and testosterone- like agents is acceptable with a 30-day washout (if previous testosterone therapy was long term depot within the past 6 months, the site should contact the Medical Monitor) or any other androgenic agent.
  • Treatment with any of the following hormone replacement therapies for metastatic breast cancer. Prior use in the adjuvant or neoadjuvant setting is allowed if the treatment is discontinued greater than 30 days prior to randomization
  • Estrogens
  • Megestrol acetate
  • Testosterone
  • All other concurrent anticancer treatments (including, but not limited to, all SERMs unless randomized to the Control Treatment Group with a SERM as the control treatment, AIs unless randomized to Control Treatment Group (exemestane or exemestane plus everolimus) with the AI containing treatment as the control treatment, and all CDK 4/6 inhibitors)
  • An abnormal ECG result which, based on the investigator's clinical judgment, would place the subject at increased risk
  • Has a known additional, invasive, malignancy that is progressing or required active treatment in the last 5 years [note: subjects with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, ductal breast carcinoma in situ, bladder cancer (superficial treated), or cervical carcinoma in situ that have undergone potentially curative therapy are not excluded]
  • Pregnant, lactating, or breastfeeding, or intending to become pregnant during the study or within 60 days after the final dose of study treatment

Trial locations and contacts

26 sites in 1 country.

26 sites in 1 country

United States26 sites

  • Alaska Oncology and Hematology, LLC.

    Anchorage, Alaska, 99508

  • University Cancer & Blood Center

    Athens, Georgia, 30607

  • Ironwood Cancer and Research Centers

    Chandler, Arizona, 85224

  • The Lindner Center for Research and Education at the Christ Hospital

    Cincinnati, Ohio, 45219

  • Morton Plant Hospital/ BayCare Health System, Inc

    Clearwater, Florida, 33756

  • Astera Cancer Care

    East Brunswick, New Jersey, 08816

  • Revive Research Institute

    Farmington Hills, Michigan, 48073

  • Banner Health/ Banner MD Anderson Cancer Center

    Gilbert, Arizona, 85234

  • The Oncology Insitute of Hope and Innovation

    Glendale, California, 91204

  • Tennessee Cancer Specialists

    Knoxville, Tennessee, 37909

  • California Research Institute (CRI)

    Los Angeles, California, 90027

  • University of Miami- Sylvester Comprehensive Cancer CenterUniversity of Miami- Sylvester Comprehensive Cancer Center

    Miami, Florida, 33146

  • Miami Cancer Institute

    Miami, Florida, 33176

  • Inspira Medical Center Mullica Hill

    Mullica Hill, New Jersey, 08062

  • Baptist Clinical Research Institute

    Nashville, Tennessee, 38102

  • Touro Infirmary Infusion Center Cancer Care Division-Oncology Research

    New Orleans, Louisiana, 70115

  • Magee-Women's Hospital

    Pittsburgh, Pennsylvania, 15219

  • MultiCare Institute for Research and Innovation

    Puyallup, Washington, 98372

  • Blessing Corporate Services

    Quincy, Illinois, 62301

  • University of California San Francisco Comprehensive Cancer Center

    San Francisco, California, 94143

  • Providence Medical Group

    Santa Rosa, California, 95043

  • University of Washington

    Seattle, Washington, 98109

  • MBCCOP - LSU Health Sciences Center

    Shreveport, Louisiana, 71103

  • Cancer Care Northwest

    Spokane, Washington, 99216

  • Revive Research Institute

    Sterling Heights, Michigan, 48314

  • Inspira Medical Center

    Vineland, New Jersey, 08360

Other trials in United States

About this study

Official title: P2 Efficacy Evaluation of Sabizabulin Monotherapy Versus Active Control for Treatment of ER+HER2- MBC in Patients Who Have Shown Previous Disease Progression on a Nonsteroidal Aromatase Inhibitor, Fulvestrant and CDK 4/6 Inhibitor

To demonstrate the efficacy of sabizabulin in the treatment of ER+HER2- metastatic breast cancer (MBC) as measured by progression free survival (PFS) by RECIST v1.1.

Read the detailed description

This study is a multicenter, randomized, open-label, two treatment arm, efficacy and safety study. Subjects will be randomized to the two treatment arms in a 1:1 fashion.

The primary efficacy endpoint of the study will be the median PFS by RECIST v1.1.

Subjects will continue study treatment until disease progression confirmed by blinded independent central reader (BICR) is observed. A safety follow up visit will occur approximately 30 days after last dose of study drug.

Being tested
Sabizabulin, Exemestane monotherapy, exemestane plus everolimus, or selective estrogen receptor modulator
Medical subject headings
Breast Neoplasms

What participants receive

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

  • SabizabulinDrug

    Also called Veru-111

    32mg each day by mouth

  • Exemestane monotherapy, exemestane plus everolimus, or selective estrogen receptor modulatorDrug

    Also called exemestane

    Subjects in the Control Treatment Group will receive an ER targeted therapy limited to exemestane monotherapy, exemestane plus everolimus, or selective estrogen receptor modulator (SERM) approved for the treatment of breast cancer and is part of the standard of care at the clinical study site until disease progression is observed and confirmed by BICR. The investigator decision of which comparator treatment will be used will be made prior to randomization.

Study groups in NCT05079360
Study groupRoleWhat they receive
Sabizabulin Treatment GroupExperimentalSubjects in the Sabizabulin Treatment Group will receive sabizabulin 32mg each day by mouth until disease progression is observed and confirmed by BICR.
Receives: Drug: Sabizabulin
Control Treatment GroupActive comparatorSubjects in the Control Treatment Group will receive an ER targeted therapy limited to exemestane monotherapy, exemestane plus everolimus, or selective estrogen receptor modulator (SERM) approved for the treatment of breast cancer and is part of the standard of care at the clinical study site until disease progression is observed and confirmed by BICR. The investigator decision of which comparator treatment will be used will be made prior to randomization.
Receives: Drug: Exemestane monotherapy, exemestane plus everolimus, or selective estrogen receptor modulator

What is being measured

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

  1. Efficacy of sabizabulin in the treatment of estrogen receptor positive (ER+HER2) metastatic breast cancer (MBC)

    To demonstrate the efficacy of sabizabulin in the treatment of ER+HER2- metastatic breast cancer (MBC) as measured by progression free survival (PFS) by RECIST v1.1.

    Measured: Day 1 to Day 300

Secondary outcomes (1)

  1. Objective Response Rate (ORR)

    Objective Response Rate (ORR), proportion of subjects with a best tumor response of ORR (partial response [PR] or complete response [CR]) on study

    Measured: Day 1 to Day 300

Timeline

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

  1. First posted15 Oct 2021
  2. Study start15 Mar 2023 (estimated)
  3. Primary completion30 Mar 2024 (estimated)
  4. Study completion26 May 2024 (estimated)

Why it stopped: Decided to halt and will potentially reopen in the future.

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Multicenter, randomized, open-label, two treatment arm study
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05079360
Sponsor's protocol ID
V2011201
Status last verified
Mar 2023
First submitted
1 Oct 2021
Last updated
24 Mar 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Sabizabulin and Exemestane monotherapy, exemestane plus everolimus, or selective estrogen receptor modulator in people with Metastatic Breast Cancer, run by Veru Inc. at 26 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 25 inclusion and 25 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: withdrawn, as of the sponsor's last update on 24 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 26 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 withdrawn before enrolling participants, so there are no results.

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 sabizabulin in the treatment of estrogen receptor positive (ER+HER2) metastatic breast cancer (MBC) (time frame: Day 1 to Day 300). 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 NCT05079360.

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 24 Mar 2023.

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