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Microtubule Inhibitor

Sabizabulin for Breast Cancer

Phase 2
Waitlist Available
Research Sponsored by Veru Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1 to day 300
Awards & highlights

Study Summary

This trial is testing whether a drug called sabizabulin can help people with a certain type of breast cancer by measuring how long they live without their disease getting worse.

Eligible Conditions
  • Metastatic Breast Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1 to day 300
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 to day 300 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Efficacy of sabizabulin in the treatment of estrogen receptor positive (ER+HER2) metastatic breast cancer (MBC)
Secondary outcome measures
Objective Response Rate (ORR)

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Sabizabulin Treatment GroupExperimental Treatment1 Intervention
Subjects in the Sabizabulin Treatment Group will receive sabizabulin 32mg each day by mouth until disease progression is observed and confirmed by BICR.
Group II: Control Treatment GroupActive Control1 Intervention
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.

Find a Location

Who is running the clinical trial?

Veru Inc.Lead Sponsor
10 Previous Clinical Trials
692 Total Patients Enrolled
BarnetteStudy ChairVeru Inc.
9 Previous Clinical Trials
668 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is enrollment for this clinical experiment still open?

"No longer accepting patients, this trial was posted on December 15th 2022 and its last update occurred on October 31st of the same year. For those seeking other medical studies, there are 2,292 trials for breast cancer and 195 for Sabizabulin presently recruiting individuals."

Answered by AI

How many participants are involved in this experimental trial?

"This clinical trial is no longer recruiting participants; it was initially uploaded to the database on December 15th 2022 and last updated October 31st of that same year. If you are searching for alternate studies, there are 2297 trials with breast cancer as its main focus area and 195 Sabizabulin studies actively enrolling patients."

Answered by AI

What are the eligibility requirements for participating in this research endeavor?

"This medical trial is searching for 200 participants with breast cancer, aged between 18 and 100. To qualify as a candidate, an individual must have undergone tubal ligation (if applicable), communicate adequately, be menopausal if below the age of 55 or post-bilateral oophorectomy if over that age bracket, and they should also use barrier methods in tandem with spermicidal materials."

Answered by AI

In what cases is Sabizabulin an appropriate course of treatment?

"Sabizabulin is widely prescribed to treat advanced prostate cancer that responds to androgenic hormones. It may also be employed in cases of hypoestrogenism, amenorrhea for the past 6 months, or as a last line of defense against refractory renal cell carcinoma."

Answered by AI

To what extent are individuals under 45 years old eligible for participation in this experiment?

"This clinical trial seeks individuals aged 18 to 100. Additionally, there are 88 trials for minors and 2364 studies suitable for senior citizens."

Answered by AI

What past experiments have been undertaken to explore the utility of Sabizabulin?

"Sabizabulin was initially tested in 1996 at the National Institutes of Health Clinical Centre. So far, 690 clinical trials have been concluded and 195 are still active, with a considerable number commencing from Cincinnati, Ohio."

Answered by AI

In what areas has this experiment been implemented?

"This study is currently operating at 27 sites, located in various cities such as Cincinnati, Clearwater and Glendale. Therefore, it's advisable to opt for the closest trial centre in order to minimize travel needs if you decide to join the clinical trial."

Answered by AI

How does Sabizabulin pose a risk to individuals?

"Based on the evidence available, Sabizabulin has been assigned a safety rating of 2 due to its Phase 2 trial status. While there is some data confirming safety, no studies have yet established efficacy."

Answered by AI

Who else is applying?

What state do they live in?
Massachusetts
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Did not meet criteria

How responsive is this trial?

Typically responds via
Phone Call
Recent research and studies
clinicaltrials.govStudy
Efficacy Evaluation of Sabizabulin Monotherapy Versus Active Control for Treatment of ER+HER2- Metastatic Breast Cancer
2023. "Efficacy Evaluation of Sabizabulin Monotherapy Versus Active Control for Treatment of ER+HER2- Metastatic Breast Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05079360.
~0 spots leftby Apr 2025
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