Viewing Study NCT00511043



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Last Modification Date: 2024-10-26 @ 9:35 AM
Study NCT ID: NCT00511043
Status: TERMINATED
Last Update Posted: 2014-12-09
First Post: 2007-08-01

Brief Title: PTK787 in Refractory or Relapsed Diffuse Large Cell Lymphoma
Sponsor: David Rizzieri MD
Organization: Duke University

Study Overview

Official Title: Phase II Open Label Study of PTK787ZK222584 in Adults Patients With Refractory or Relapsed Diffuse Large Cell Lymphoma
Status: TERMINATED
Status Verified Date: 2014-11
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Manufacturer stopped drug development
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: This is a phase II open label study to assess the efficacy and safety of PTK787ZK222584 in adults with relapsed or refractory diffuse large cell lymphoma DLCL All subjects will receive PTK787ZK222584 Subjects who tolerate the study target dose of 1250mg will remain on that dose until study completion at 12 months or until disease progression unacceptable toxicity withdrawal of consent or non-compliance with the protocol requirement
Detailed Description: In order for tumors to grow and spread to other parts of the body they need to have a growing blood supply Tumor cells have been shown to produce substances that stimulate the abnormal growth of new blood vessels that allow the tumor to grow In adults blood vessel cells normally divide very rapidly It is thought that PTK787ZK222584 may interfere with the growth of new blood vessels A drug that interferes with the growth of new blood vessels might stop tumor growth and possibly shrink the tumor by keeping it from receiving nutrients and oxygen supplied by the blood vessels Since normal blood vessel cells divide very rapidly it might be possible to stop tumor growth without harming normal tissues

The purpose of this study is to find out if an investigational drug PTK787ZK 222584 is safe and effective in treating relapsed or refractory diffuse large cell lymphoma

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None
Secondary IDs
Secondary ID Type Domain Link
7416 OTHER Legacy Duke IRB number None
CPTK787AUS39 None None None