NCT00511043

PTK787 in Refractory or Relapsed Diffuse Large Cell Lymphoma

Phase II Open Label Study of PTK787/ZK222584 in Adults Patients With Refractory or Relapsed Diffuse Large Cell Lymphoma

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: David Rizzieri, MD · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a phase II open label study to assess the efficacy and safety of PTK787/ZK222584 in adults with relapsed or refractory diffuse large cell lymphoma (DLCL). All subjects will receive PTK787/ZK222584. 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 PTK787/ZK222584 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, PTK787/ZK 222584 is safe and effective in treating relapsed or refractory diffuse large cell lymphoma.

Conditions

• Lymphoma, Large-Cell, Diffuse

Interventions

Type	Name	Description
DRUG	PTK787	PTK787 - 1250mg p.o. daily. Initial dose of 750mg p.o daily starting on day 1 and increased weekly to an intermediate dose of 1000 mg and then a target dose of 1250mg unless a grade ≥ 2 toxicity. Patients 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 patient non-compliance with the protocol requirement.

Timeline

• Start date: 2005-11-01
• Primary completion: 2009-08-01
• Completion: 2010-06-01
• First posted: 2007-08-03
• Last updated: 2014-12-09

Locations

3 sites across 1 country: United States