Trial Information

Summary: A Phase I Study of Indibulin in Advanced Solid Tumors

This is a dose-escalating study to define the safety profile, the maximum tolerated dose, pharmacokinetics, and tumor response of continuous orally administered Indibulin in subjects with advanced, refractory solid tumors. Pharmacokinetics (PKs) is a way to determine the levels of Indibulin and to study how the body processes the drug by looking at how the body absorbs, distributes, metabolizes, and eliminates the drug. This is done with frequent blood samples taken on key days during the first four weeks of treatment.

Indibulin is a novel synthetic anti-mitotic agent that arrests tumor cell growth at the G2/M phase of the cell cycle. It is not approved by the FDA and is an investigational drug.

Patient Inclusion Criteria:

• Measurable lesion
• Normal kidney, liver, and bone marrow function

Not all eligibility criteria are listed. Additional criteria must be met in order to be eligible.

Patient Exclusion Criteria:

• History of uncontrolled cardiac arrhythmia
• Radiation within 3 weeks of starting the study
• Chemotherapy within 4 weeks of starting the study

If you would like to learn more about participating in this study, please send an e-mail message using the form below.