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Microtubule Inhibitor

Single Arm for Breast Cancer

Phase 1 & 2
Waitlist Available
Research Sponsored by Ziopharm
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 duration of study, approximately one year
Awards & highlights
No Placebo-Only Group

Summary

This study is a Phase I/II trial of a novel Indibulin dosing schedule for the treatment of metastatic breast cancer. Eligible patients will have measurable or non-measurable, metastatic or unresectable, locally advanced breast cancer and may have received any number of prior therapies for their disease. It is expected that the Phase I portion will enroll up to 20 patients and the Phase II portion will enroll up to 45 patients.

Eligible Conditions
  • Breast Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~throughout study, approximately one year
This trial's timeline: 3 weeks for screening, Varies for treatment, and throughout study, approximately one year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Phase I- Maximum Tolerated Dose
Phase II- Progression Free Survival
Secondary study objectives
Phase I- Number of participants with Adverse Events as a measure of safety and tolerability
Phase I- Pharmacokinetics of indibulin in study subject plasma assessed in Cycle 1 Day 1 and Cycle 1 Day 5 per schedule below in Description section.
Phase I- Toxicity
+3 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Single ArmExperimental Treatment1 Intervention
open label, single arm, unblinded

Find a Location

Who is running the clinical trial?

ZiopharmLead Sponsor
35 Previous Clinical Trials
3,943 Total Patients Enrolled
Alaunos TherapeuticsLead Sponsor
40 Previous Clinical Trials
4,167 Total Patients Enrolled
Memorial Sloan Kettering Cancer CenterOTHER
1,965 Previous Clinical Trials
596,923 Total Patients Enrolled
206 Trials studying Breast Cancer
82,295 Patients Enrolled for Breast Cancer
~4 spots leftby Nov 2025
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