Breast Cancer Clinical Trial

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

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.

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Full 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.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

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
Age <55 years and one year or more of amenorrhea, with an estradiol assay <20 pgmL
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

Exclusion Criteria:

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
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

Study is for people with:

Breast Cancer

Phase:

Phase 2

Estimated Enrollment:

200

Study ID:

NCT05079360

Recruitment Status:

Not yet recruiting

Sponsor:

Veru Inc.

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There are 26 Locations for this study

See Locations Near You

Alaska Oncology and Hematology, LLC.
Anchorage Alaska, 99508, United States More Info
Talia Wyckoff
Contact
907-257-9851
[email protected]
Steven Liu
Principal Investigator
Ironwood Cancer and Research Centers
Chandler Arizona, 85224, United States More Info
Andrea Garcia
Contact
480-398-7671
[email protected]
Sujith Kalmadi
Principal Investigator
Banner Health/ Banner MD Anderson Cancer Center
Gilbert Arizona, 85234, United States More Info
Karol Banks
Contact
480-256-3333
[email protected]
Qing Zhao
Principal Investigator
The Oncology Insitute of Hope and Innovation
Glendale California, 91204, United States More Info
Kirsten Bettino
Contact
818-844-1678
[email protected]
Paul La Porte
Principal Investigator
California Research Institute (CRI)
Los Angeles California, 90027, United States More Info
Clare Gregorio
Contact
323-660-6200
[email protected]
Ghassan Al-Jazayrly
Principal Investigator
University of California San Francisco Comprehensive Cancer Center
San Francisco California, 94143, United States More Info
Hope Rugo
Principal Investigator
Providence Medical Group
Santa Rosa California, 95043, United States More Info
Kim M Young
Contact
707-799-9443
[email protected]
Jarrod Holmes
Principal Investigator
Morton Plant Hospital/ BayCare Health System, Inc
Clearwater Florida, 33756, United States
University of Miami- Sylvester Comprehensive Cancer CenterUniversity of Miami- Sylvester Comprehensive Cancer Center
Miami Florida, 33146, United States More Info
Onaidy Teresa Torres
Contact
305-243-6823
[email protected]
Elisa Krill Jackson
Principal Investigator
Miami Cancer Institute
Miami Florida, 33176, United States More Info
Jacqueline C Lebron
Contact
786-527-8546
[email protected]
Lauren Carcas
Principal Investigator
University Cancer & Blood Center
Athens Georgia, 30607, United States More Info
Jamie Hodgsen
Contact
706-353-5000
[email protected]
Gustavo Westin
Principal Investigator
Blessing Corporate Services
Quincy Illinois, 62301, United States More Info
Kiley McGlauchlen
Contact
217-223-8400
[email protected]
Kellie Flippin
Principal Investigator
Touro Infirmary Infusion Center Cancer Care Division-Oncology Research
New Orleans Louisiana, 70115, United States More Info
Mary Ellen Burns
Contact
504-897-7419
[email protected]
Scott Sonnier
Principal Investigator
MBCCOP - LSU Health Sciences Center
Shreveport Louisiana, 71103, United States More Info
Lisa McCary
Contact
318-813-1465
[email protected]
Gary Burton
Principal Investigator
Revive Research Institute
Farmington Hills Michigan, 48073, United States
Revive Research Institute
Sterling Heights Michigan, 48314, United States More Info
Sikar R Grewal
Contact
248-564-1485
[email protected]
Adil Akhtar
Principal Investigator
Astera Cancer Care
East Brunswick New Jersey, 08816, United States More Info
Percy C Yeung
Contact
732-390-7750
[email protected]
Bruno Fang
Principal Investigator
Inspira Medical Center Mullica Hill
Mullica Hill New Jersey, 08062, United States More Info
Sami M Abate
Contact
856-508-2119
[email protected]
Erev Tubb
Principal Investigator
Inspira Medical Center
Vineland New Jersey, 08360, United States More Info
Sami M Abate
Contact
856-641-5086
[email protected]
Mylene Go
Principal Investigator
The Lindner Center for Research and Education at the Christ Hospital
Cincinnati Ohio, 45219, United States More Info
Susan Reilly
Contact
513-585-2165
[email protected]
Gina Chung
Principal Investigator
Magee-Women's Hospital
Pittsburgh Pennsylvania, 15219, United States More Info
Romenta Pollard
Contact
412-641-5430
[email protected]
Adam Brufsky
Principal Investigator
Tennessee Cancer Specialists
Knoxville Tennessee, 37909, United States More Info
Whitney Henderson
Contact
865-934-2674
[email protected]
Robert D Schumaker
Principal Investigator
Baptist Clinical Research Institute
Nashville Tennessee, 38102, United States
MultiCare Institute for Research and Innovation
Puyallup Washington, 98372, United States More Info
Danielle Wahinekapu
Contact
253-697-1310
[email protected]
Meghana Bansal
Principal Investigator
University of Washington
Seattle Washington, 98109, United States More Info
Jenna o Olyanich
Contact
206-606-2053
[email protected]
Hannah Linden
Principal Investigator
Cancer Care Northwest
Spokane Washington, 99216, United States More Info
Bethany Giachetti
Contact
509-228-1684
[email protected]
Kristine Rinn
Principal Investigator

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Phase:

Phase 2

Estimated Enrollment:

200

Study ID:

NCT05079360

Recruitment Status:

Not yet recruiting

Sponsor:


Veru Inc.

How clear is this clinincal trial information?

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