MP470 in Treating Patients With Unresectable or Metastatic Solid Tumor or Lymphoma
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|ClinicalTrials.gov Identifier: NCT00504205|
Recruitment Status : Terminated (Withdrawn as trial was never activated by SuperGen)
First Posted : July 19, 2007
Last Update Posted : August 2, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|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||Not Applicable|
- 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).
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|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|
|Study Start Date :||May 2007|
|Actual Primary Completion Date :||December 2008|
|Actual Study Completion Date :||March 2010|
- Response to treatment according to RECIST criteria
- Pharmacodynamic assessments (e.g., changes in phosphorylation of ERK, Rad51 expression, number of CTCs, and tumor glucose metabolism measured by FDG-PET)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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, Inc.|