A Phase I Study Assessing the Effects of Food and Formulation on the Processing of KPT-330 in Patients with Sarcoma

Protocol
13-145
Full Title
An Open Label Phase IB Trial to Evaluate the Effects of Food and Formulation on Pharmacokinetics of the Oral Selective Inhibitor of Nuclear Export (SINE) KPT-330 in Patients with Soft-Tissue or Bone Sarcoma
Phase
I
Purpose

Cancer cells differ from normal cells because they don’t know when to stop growing. One way they do this is by getting rid of certain “tumor suppressor proteins” that would normally cause cancer cells to die. KPT-330 is an investigational drug designed to inhibit cancer growth by trapping tumor suppressor proteins inside cancer cells, causing them to die. KPT-330 is being evaluated in patients with different types of cancer.

In this study, researchers want to assess the effects of food (high-fat versus low-fat meal) and formulation (tablet versus capsule) on the way the body processes KPT-330 in patients with sarcoma of the bones or soft tissue. Patients will be randomly assigned to one of two treatment schedules in which they take the drug as a tablet and as a capsule on an empty stomach, with a low-fat meal, and with a high-fat meal over a four-week period.

Eligibility

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

  • Patients must have soft-tissue sarcoma or osteosarcoma that has spread (metastasized) despite at least one prior regimen of therapy for advanced disease. Those with gastrointestinal stromal tumors may not participate in this study.
  • Patients with cancer in the liver (primary or metastatic) may not participate.
  • At least 3 weeks should have passed since completion of prior therapy (4 weeks since 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 about this study and to inquire about eligibility, please contact Dr. Mrinal Gounder at 646-888-4226.

Disease(s)
Primary Bone: Osteosarcoma
Sarcomas
Sarcomas: Osteosarcoma
Sarcomas: Soft Tissue Sarcoma
Locations