Safety Study of PLX108-01 in Patients With Solid Tumors
This trial is active, not recruiting.
|Start date||September 2009|
|End date||June 2017|
|Trial size||150 participants|
|Trial identifier||NCT01004861, PLX108-01|
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.
|United States||No locations recruiting|
|Other countries||No locations recruiting|
|Scottsdale, AZ||TGen Clinical Research Service at Scottsdale Healthcare||no longer recruiting|
|Los Angeles, CA||UCLA / Jonsson Comprehensive Cancer Center||no longer recruiting|
|Los Angeles, CA||UCLA||no longer recruiting|
|Denver, CO||Rocky Mountain Cancer Centers||no longer recruiting|
|Boston, MA||Massachusetts General Hospital||no longer recruiting|
|Boston, MA||Dana-Farber Cancer Institute||no longer recruiting|
|Charlestown, MA||Massachusetts General Hospital||no longer recruiting|
|Las Vegas, NV||Comprehensive Cancer Centers of Nevada||no longer recruiting|
|New York, NY||Memorial Sloan-Kettering Cancer Center||no longer recruiting|
|Philadelphia, PA||Pennsylvania Oncology Hematology Associates||no longer recruiting|
|Philadelphia, PA||Fox Chase Cancer Center||completed|
|Nashville, TN||Vanderbilt University / Ingram Cancer Center||no longer recruiting|
|Dallas, TX||Texas Oncology, PA (North)||no longer recruiting|
|Norfolk, VA||Virginia Oncology Associates||no longer recruiting|
|Spokane, WA||Evergreen Hematology & Oncology||no longer recruiting|
|Intervention model||single group assignment|
Safety: subject incidence of adverse events, first-cycle DLTs and clinically significant changes in vital signs, ECGs and clinical laboratory tests
time frame: till end of study
PK profile: PLX3397 PK parameters including, but not limited to, maximum observed concentration (Cmax), area under the plasma concentration-time curve and half-life
time frame: till end of study
All participants at least 18 years old.
- Age 18 and older
- Solid tumors refractory to standard therapy
- For the Extension cohorts, patients must have measurable disease by RECIST criteria and meet the following disease-specific criteria:
- For advanced or recurrent mucoepidermal carcinoma (MEC) of the salivary gland, patients must not be candidates for curative surgery or radiotherapy.
- For pigmented villo-nodular synovitis (PVNS), patients must have a histologically confirmed diagnosis of inoperable progressive or relapsing PVNS, or resectable tumor requesting mutilating surgery, as well as demonstrated progressive disease in the last 12 months.
- For gastrointestinal stromal tumors (GIST), patients must have failed previous therapy with imatinib and sunitinib. Patients with known PDGFR mutations are excluded, but mutation testing is not required for study entry.
- For anaplastic thyroid cancer (ATC), patients must have histologically or cytologically diagnosed advanced ATC.
- For metastatic solid tumors with documented malignant pleural and/or peritoneal effusions, patients must not be receiving specific therapy for the effusion or have an indwelling drain.
- ECOG performance status 0 or 1
- Life expectancy >= 3 months
- Adequate hepatic, renal, and bone marrow function
- Specific anti-cancer therapy within 3 weeks of study start
- Uncontrolled intercurrent illness
- Refractory nausea or vomiting, or malabsorption
- Mean QTc >= 450 msec (for males) or QTc >= 470 msec (for females)
|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|
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