PTK787 in Refractory or Relapsed Diffuse Large Cell Lymphoma
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|ClinicalTrials.gov Identifier: NCT00511043|
Recruitment Status : Terminated (Manufacturer stopped drug development)
First Posted : August 3, 2007
Last Update Posted : December 9, 2014
|Condition or disease||Intervention/treatment||Phase|
|Lymphoma, Large-Cell, Diffuse||Drug: PTK787||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Open Label Study of PTK787/ZK222584 in Adults Patients With Refractory or Relapsed Diffuse Large Cell Lymphoma|
|Study Start Date :||November 2005|
|Actual Primary Completion Date :||August 2009|
|Actual Study Completion Date :||June 2010|
Experimental: All pts
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.
- Response [ Time Frame: approximately 1 year ]
- Safety [ Time Frame: 30 days post last dose of study drug ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00511043
|United States, North Carolina|
|University of North Carolina at Chapel Hill|
|Chapel Hill, North Carolina, United States, 27599|
|South Carolina Oncology Associates|
|Columbia, North Carolina, United States, 29210|
|Duke University Medical Center|
|Durham, North Carolina, United States, 27710|
|Principal Investigator:||David A Rizzieri, MD||Duke University|