Safety Study to Determine the Maximum Tolerated Dose, Pharmacokinetics and Pharmacodynamics of Oral MP470, a Multi-Targeted Tyrosine Kinase Inhibitor, in Patients With Solid Malignancies
OBJECTIVES:
Primary
- Estimate the maximum tolerated dose (MTD) and define the safety profile of
multitargeted receptor tyrosine kinase inhibitor MP470 in humans.
Secondary
- Estimate the therapeutic response rate for patients receiving MP470.
- Define the human pharmacokinetic (PK) and pharmacodynamic (PD) profiles of MP470
capsules
- Evaluate PK-PD relationships.
OUTLINE: This is a multicenter study.
Patients receive oral multitargeted receptor tyrosine kinase inhibitor MP470 until the
maximum tolerated dose is determined.
Pharmacokinetic and pharmacodynamic analyses are carried out to determine changes in
phosphorylation of extracellular signal-regulated kinase (ERK), Rad51 expression, number of
circulating tumor cells (CTCs), and tumor glucose metabolism measured by
2-[18F]fluoro-2-deoxyglucose positron emission tomography (FDG-PET).
Interventional
Primary Purpose: Treatment
Safety
Yes
Gregory Berk, MD
Study Chair
Astex Pharmaceuticals
Unspecified
CDR0000556524
NCT00504205
May 2007
Name | Location |
---|---|
Virginia G. Piper Cancer Center at Scottsdale Healthcare - Shea | Scottsdale, Arizona 85260 |
South Texas Accelerated Research Therapeutics | San Antonio, Texas 78229 |