A Phase I Study of PLX3397 in Patients with Advanced Solid Tumors

Protocol
12-156
Full Title
A Phase 1 Study to Assess Safety, Pharmacokinetics, and Pharmacodynamics of PLX3397 in Patients with Advanced, Incurable, Solid Tumors in which the Target Kinases Are Linked to Disease Pathophysiology
Phase
I
Purpose

PLX3397 is an investigational anticancer drug that works by targeting a family of enzymes called kinases - particularly Kit, Flt3, and Fms kinase - which drive cancer growth. The purpose of this study is to examine the effect of PLX3397 treatment in patients with advanced solid tumors fueled by these enzymes and which cannot be treated successfully with other therapies.

These tumors include salivary mucoepidermal cancer, pigmented villonodular synovitis, malignant gastrointestinal stromal tumor, anaplastic thyroid cancer, tumors with documented pericardial, pleural, or peritoneal effusions, and any other tumors that doctors feel may respond to PLX3397.

PLX3397 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 salivary mucoepidermal cancer, pigmented villonodular synovitis, malignant gastrointestinal stromal tumor, anaplastic thyroid cancer, tumors with documented pericardial, pleural, or peritoneal effusions, or any other tumors that doctors feel may respond to PLX3397.
  • Patients’ tumors must not be curable with standard therapies.
  • Patients must have recovered from the serious side effects of prior therapies before entering 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.
  • Patients must be age 18 or older.

For more information about this study and to inquire about eligibility, please contact Dr. William Tap at 646-888-4163.

Disease(s)
Sarcomas
Sarcomas: Soft Tissue Sarcoma
Thyroid Cancer
Locations