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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
Age ≥ 18 years
Histologic or cytologic confirmation of invasive carcinoma of the breast.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up duration of study, approximately one year
Awards & highlights
Study 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
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ throughout study, approximately one year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~throughout study, approximately one year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Phase I- Maximum Tolerated Dose
Phase II- Progression Free Survival
Secondary outcome measures
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 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Single ArmExperimental Treatment1 Intervention
open label, single arm, unblinded
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Who is running the clinical trial?
ZiopharmLead Sponsor
35 Previous Clinical Trials
3,943 Total Patients Enrolled
Alaunos TherapeuticsLead Sponsor
40 Previous Clinical Trials
4,339 Total Patients Enrolled
Memorial Sloan Kettering Cancer CenterOTHER
1,928 Previous Clinical Trials
591,748 Total Patients Enrolled
203 Trials studying Breast Cancer
95,169 Patients Enrolled for Breast Cancer
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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