A Phase I Study of Iso-Fludelone in Patients with Advanced Solid Tumors

Protocol
10-202
Full Title
A Phase I, Open-Label, Dose-Escalation Safety and Pharmacokinetic Study of Iso-Fludelone in Patients with Advanced Solid Tumors
Phase
I
Purpose

The purpose of this study is to find the highest dose of iso-fludelone that can be given safely to patients with advanced solid tumors that have progressed despite standard therapy or for which no standard therapy exists. Iso-fludelone belongs to the epothilone family of drugs. It works by attaching to proteins in cancer cells called tubulins, which cancer cells need to grow. Laboratory studies have shown that iso-fludelone slowed or stopped cancer cells from growing.

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have a confirmed diagnosis of an advanced solid tumor that has progressed despite standard therapy or for which no standard therapy exists.
  • At least 3 weeks must have passed since completion of prior therapies, and patients must have recovered from any side effects.
  • Patients must be physically well enough that they are fully ambulatory, capable of all self care, and are capable of all but physically strenuous activities. As an example, patients must be well enough that they would be able to carry out office work or light housework.
  • Patients must be age 18 or older.

For more information about this study and to inquire about eligibility, please contact Dr. Mrinal Gounder at 646-888-4226.

Disease(s)
Solid Tumors
Locations

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