Safety Study of PLX108-01 in Patients With Solid Tumors

Status: Recruiting
Phase: Phase 1
Diagnosis: Solid Tumor/Phase I
NCT ID: NCT01004861 (View complete trial on
DFCI Protocol ID: 09-307


PLX3397 is a selective inhibitor of Fms, Kit, and oncogenic Flt3 activity. The primary objective of this study is to evaluate the safety and pharmacokinetics of orally administered PLX3397 in patients with advanced, incurable, solid tumors in which these target kinases are linked to disease pathophysiology. These tumors include, but are not limited to, acute myelogenous leukemia (Flt3), gastrointestinal stromal tumor and neurofibromatosis-1 (Kit), and glioma, breast cancer, prostate cancer, multiple myeloma, Hodgkin lymphoma, and osteosarcoma (Fms/CSF-1). The secondary objective is to measure the pharmacodynamic activity of PLX3397 via plasma and urine biomarkers of Fms activity.


Conducting Institutions:
Beth-Israel Deaconess Medical Center, Dana-Farber Cancer Institute, Massachusetts General Hospital, Brigham and Women's Hospital

Overall PI:
Eunice Kwak, MD, Massachusetts General Hospital

Site-responsible Investigators:
Geoffrey Shapiro, MD, PhD, Dana-Farber Cancer Institute
Bruce Dezube, MD, Beth Israel Deaconess Medical Center

Beth-Israel Deaconess Medical Center: Cancer Trials Call Center, 617-667-3060
Massachusetts General Hospital: Cancer Trials Call Center, 877-789-6100
Dana-Farber Cancer Institute: Andrew Wolanski, 617-632-6623,

Eligibility Criteria

Inclusion Criteria: - Age 18 and older - Solid tumors refractory to standard therapy - ECOG performance status 0 or 1 - Life expectancy > 3 months - Adequate hepatic, renal, and bone marrow function Exclusion Criteria: - Specific anti-cancer therapy within 3 weeks of study start - Uncontrolled intercurrent illness - Refractory nausea or vomiting, or malabsorption - Mean QTc > 450 msec
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