NCT00504205

MP470 in Treating Patients With Unresectable or Metastatic Solid Tumor or Lymphoma

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Astex Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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).

Conditions

• Lymphoma
• Unspecified Adult Solid Tumor, Protocol Specific

Interventions

Type	Name	Description
DRUG	multitargeted receptor tyrosine kinase inhibitor MP470
OTHER	laboratory biomarker analysis
OTHER	pharmacological study
PROCEDURE	positron emission tomography

Timeline

• Start date: 2007-05-01
• Primary completion: 2008-12-01
• Completion: 2010-03-01
• First posted: 2007-07-19
• Last updated: 2013-08-02

Locations

2 sites across 1 country: United States