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Study of a Novel Indibulin Dosing Schedule for the Treatment of Metastatic Breast Cancer

NCT01113970 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2013-01-30

No results posted yet for this 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.

Conditions

Interventions

DRUG

Indibulin

Indibulin given orally once a day for 5 days followed by a 9 day rest

Sponsors & Collaborators

Principal Investigators

  • Jonathan J. Lewis, MD, PhD · ZIOPHARM, Oncology, Inc.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-03-31
Primary Completion
2013-05-31
Completion
2013-05-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01113970 on ClinicalTrials.gov