A Phase I Study of KPT-330 in Patients with Advanced or Metastatic Solid Tumors

Protocol
12-258
Full Title
A Phase I Study of the Safety, Pharmacokinetics and Pharmacodynamics of Escalating Doses of the Selective Inhibitor of Nuclear Export (SINE) KPT-330 in Patients with Advanced or Metastatic Solid Tumor Malignancies
Phase
I
Purpose

The purpose of this study is to find the highest dose of an investigational drug called KPT-330 that can be given safely in patients with advanced or metastatic solid tumors that persist or have returned after standard therapy, or for which no standard therapy exists. KPT-330 works by blocking the movement of proteins that cancer cells use to escape the natural control mechanisms in the body that normally inhibit cancer growth.

In order for a cancer cell to grow, there are certain proteins that need to be shuttled from the center of the cell (nucleus) to the cytoplasm (the fluid surrounding the nucleus). KPT-330 works by trapping those proteins inside the nucleus, where they can no longer function to keep the cancer cell alive or promote its growth. KPT-330 is a pill that is taken orally (by mouth).

Eligibility

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

  • Patients must have an advanced or metastatic solid tumor that has continued to grow despite prior standard therapy or for which no standard therapy exists.
  • At least 3 weeks must have passed since the completion of prior therapy (6 weeks since mitomycin C or radioimmunotherapy) and 4 weeks since any major surgery and entry into the study.
  • 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.
  • This study is open to patients age 18 and older.

For more information and to inquire about eligibility for this study, please contact Dr. John Gerecitano at 212-639-3748.

Disease(s)
Solid Tumors
Locations