MP470 in Treating Patients With Unresectable or Metastatic Solid Tumor or Lymphoma
RATIONALE: MP470 may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.
PURPOSE: This clinical trial is studying the side effects and best dose of MP470 in treating patients with unresectable or metastatic refractory solid tumor, Hodgkin's lymphoma, or non-Hodgkin's lymphoma.
Unspecified Adult Solid Tumor, Protocol Specific
Drug: multitargeted receptor tyrosine kinase inhibitor MP470
Other: laboratory biomarker analysis
Other: pharmacological study
Procedure: positron emission tomography
|Study Design:||Primary Purpose: Treatment|
|Official Title:||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|
- Safety [ Designated as safety issue: Yes ]
- Response to treatment according to RECIST criteria [ Designated as safety issue: No ]
- Pharmacodynamic assessments (e.g., changes in phosphorylation of ERK, Rad51 expression, number of CTCs, and tumor glucose metabolism measured by FDG-PET) [ Designated as safety issue: No ]
|Study Start Date:||May 2007|
|Study Completion Date:||March 2010|
|Primary Completion Date:||December 2008 (Final data collection date for primary outcome measure)|
- Estimate the maximum tolerated dose (MTD) and define the safety profile of multitargeted receptor tyrosine kinase inhibitor MP470 in humans.
- 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).
Please refer to this study by its ClinicalTrials.gov identifier: NCT00504205
|United States, Arizona|
|Virginia G. Piper Cancer Center at Scottsdale Healthcare - Shea|
|Scottsdale, Arizona, United States, 85258-4512|
|United States, Texas|
|South Texas Accelerated Research Therapeutics|
|San Antonio, Texas, United States, 78229|
|Study Chair:||Gregory Berk, MD||Astex Pharmaceuticals|