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

NCT05079360 | Withdrawn Phase 2 DMC FDA Drug

• 1 other identifier: V2011201
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 26

Brief 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.

Conditions

Metastatic Breast Cancer

Outcome Measures

Primary Outcomes (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.

  Day 1 to Day 300

Secondary Outcomes (1)

• Objective Response Rate (ORR)

  Day 1 to Day 300

Study Arms (2)

Sabizabulin Treatment Group

EXPERIMENTAL

Subjects in the Sabizabulin Treatment Group will receive sabizabulin 32mg each day by mouth until disease progression is observed and confirmed by BICR.

Drug: Sabizabulin

Control Treatment Group

ACTIVE COMPARATOR

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.

Drug: Exemestane monotherapy, exemestane plus everolimus, or selective estrogen receptor modulator

Interventions

Sabizabulin DRUG

32mg each day by mouth

Also known as: Veru-111

Sabizabulin Treatment Group

Exemestane monotherapy, exemestane plus everolimus, or selective estrogen receptor modulator DRUG

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.

Also known as: exemestane

Control Treatment Group

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 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:

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Veru Inc.: lead

Study Sites (26)

Alaska Oncology and Hematology, LLC.

Anchorage, Alaska, 99508, United States

Location

Ironwood Cancer and Research Centers

Chandler, Arizona, 85224, United States

Location

Banner Health/ Banner MD Anderson Cancer Center

Gilbert, Arizona, 85234, United States

Location

The Oncology Insitute of Hope and Innovation

Glendale, California, 91204, United States

Location

California Research Institute (CRI)

Los Angeles, California, 90027, United States

Location

University of California San Francisco Comprehensive Cancer Center

San Francisco, California, 94143, United States

Location

Providence Medical Group

Santa Rosa, California, 95043, United States

Location

Morton Plant Hospital/ BayCare Health System, Inc

Clearwater, Florida, 33756, United States

Location

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

Miami, Florida, 33146, United States

Location

Miami Cancer Institute

Miami, Florida, 33176, United States

Location

University Cancer & Blood Center

Athens, Georgia, 30607, United States

Location

Blessing Corporate Services

Quincy, Illinois, 62301, United States

Location

Touro Infirmary Infusion Center Cancer Care Division-Oncology Research

New Orleans, Louisiana, 70115, United States

Location

MBCCOP - LSU Health Sciences Center

Shreveport, Louisiana, 71103, United States

Location

Revive Research Institute

Farmington Hills, Michigan, 48073, United States

Location

Revive Research Institute

Sterling Heights, Michigan, 48314, United States

Location

Astera Cancer Care

East Brunswick, New Jersey, 08816, United States

Location

Inspira Medical Center Mullica Hill

Mullica Hill, New Jersey, 08062, United States

Location

Inspira Medical Center

Vineland, New Jersey, 08360, United States

Location

The Lindner Center for Research and Education at the Christ Hospital

Cincinnati, Ohio, 45219, United States

Location

Magee-Women's Hospital

Pittsburgh, Pennsylvania, 15219, United States

Location

Tennessee Cancer Specialists

Knoxville, Tennessee, 37909, United States

Location

Baptist Clinical Research Institute

Nashville, Tennessee, 38102, United States

Location

MultiCare Institute for Research and Innovation

Puyallup, Washington, 98372, United States

Location

University of Washington

Seattle, Washington, 98109, United States

Location

Cancer Care Northwest

Spokane, Washington, 99216, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

sabizabulin; exemestane; Everolimus; Selective Estrogen Receptor Modulators

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Sirolimus; Macrolides; Lactones; Organic Chemicals; Estrogen Receptor Modulators; Hormone Antagonists; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses

Study Officials

• Barnette

  Veru Inc.

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Only independent central reader will be blinded
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Multicenter, randomized, open-label, two treatment arm study

Study Record Dates

• First Submitted: October 1, 2021
• First Posted: October 15, 2021
• Study Start: March 15, 2023
• Primary Completion: March 30, 2024
• Study Completion: May 26, 2024
• Last Updated: March 24, 2023

Record last verified: 2023-03

Locations

US (26)