Ignite Creation Date:
2025-12-25 @ 3:25 AM
Ignite Modification Date:
2026-03-02 @ 4:10 AM
Study NCT ID:
NCT00504205
Status:
TERMINATED
Last Update Posted:
2013-08-02
First Post:
2007-07-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
MP470 in Treating Patients With Unresectable or Metastatic Solid Tumor or Lymphoma
Sponsor:
Astex Pharmaceuticals, Inc.
Organization:
Study Overview
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
Status:
TERMINATED
Status Verified Date:
2008-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Withdrawn as trial was never activated by SuperGen
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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).
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 Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: