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| Sponsor: | Duke University |
|---|---|
| Collaborator: |
Novartis Pharmaceuticals |
| Information provided by: | Duke University |
| ClinicalTrials.gov Identifier: | NCT00511043 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Lymphoma, Large-Cell, Diffuse |
Drug: PTK787/ZK 222584 |
Phase II |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase II Open Label Study of PTK787/ZK222584 in Adults Patients With Refractory or Relapsed Diffuse Large Cell Lymphoma |
| Enrollment: | 20 |
| Study Start Date: | November 2005 |
| Estimated Study Completion Date: | November 2011 |
| Primary Completion Date: | July 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: All pts
PTK787
|
Drug: PTK787/ZK 222584
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.
Other Names:
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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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Any of the following concurrent severe and/or uncontrolled medical conditions which could compromise participation in the study:
Contacts and Locations| 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 |
More Information
| Responsible Party: | David Rizzieri, MD, Duke University Medical Center |
| ClinicalTrials.gov Identifier: | NCT00511043 History of Changes |
| Other Study ID Numbers: | 7416, CPTK787AUS39 |
| Study First Received: | August 1, 2007 |
| Last Updated: | August 17, 2011 |
| Health Authority: | United States: Food and Drug Administration |
|
PTK787 DLCL Diffuse large cell lymphoma |
|
Lymphoma Lymphoma, Large B-Cell, Diffuse Lymphoma, Non-Hodgkin Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders |
Immune System Diseases Lymphoma, B-Cell Vatalanib Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions |