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

Not Applicable

Terminated

• Conditions: Lymphoma; Unspecified Adult Solid Tumor, Protocol Specific

• Registration Number: NCT00504205
• Lead Sponsor: Astex Pharmaceuticals, Inc.

Brief 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).

Study Timeline

• Study Start: 2007-05
• Study First Submitted: 2007-07-17
• Study First Submitted QC: 2007-07-17
• Study First Posted: 2007-07-19
• Status Verified: 2008-04
• Primary Completion: 2008-12
• Study Completion: 2010-03
• Last Update Submitted: 2013-08-01
• Last Update Posted: 2013-08-02

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Safety
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)

Trial Locations

Locations (2)

South Texas Accelerated Research Therapeutics; 🇺🇸 San Antonio, Texas, United States

Virginia G. Piper Cancer Center at Scottsdale Healthcare - Shea; 🇺🇸 Scottsdale, Arizona, United States