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Brief Title: Safety Study of PLX108-01 in Patients With Solid Tumors
Official 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
Study ID: NCT01004861
Brief Summary: 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. The secondary objective is to measure the pharmacodynamic activity of PLX3397 via blood, plasma and urine biomarkers of Fms activity.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
HonorHealth, Scottsdale, Arizona, United States
UCLA, Los Angeles, California, United States
Rocky Mountain Cancer Centers, Denver, Colorado, United States
Massachusetts General Hospital, Boston, Massachusetts, United States
Dana Farber Cancer Institute, Boston, Massachusetts, United States
Comprehensive Cancer Centers of Nevada, Las Vegas, Nevada, United States
Memorial Sloan-Kettering Cancer Center (MSKCC), New York, New York, United States
Pennsylvania Oncology Hematology Associates, Philadelphia, Pennsylvania, United States
Fox Chase Cancer Center, Philadelphia, Pennsylvania, United States
Vanderbilt-Ingram Medical Center, Nashville, Tennessee, United States
Texas Oncology, PA (North), Dallas, Texas, United States
Virginia Oncology Associates, Norfolk, Virginia, United States
Evergreen Hematology & Oncology, Spokane, Washington, United States
Name: Medical Director
Affiliation: Daiichi Sankyo
Role: STUDY_DIRECTOR