Number: 201109306 Principal Investigator: Lockhart, A. Craig
Title: PDX-019: An Open-label, Phase I Study to Evaluate the Safety and Pharmacokinetics of Pralatrexate in Relapsed/Refractory Advanced Solid Tumors or Advanced Lymphoma/Myeloma Patients with Mild, Moderate, and Severe Renal Impairment
Phase: I Disease Site: Multiple Sites
Participating Site(s):
Main Campus
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You are being asked to take part in a clinical research study because you have either a relapsed (returned after initially responding to previous treatment), or refractory (has not responded to previous treatment)
advanced solid tumor (tumor in an organ) with normal renal function (renal function is how well the kidneys are working to get rid of water and body wastes as urine), or mild, moderate or severe renal impairment
(renal impairment is when your kidneys are not working as well as they should, which may cause drugs to stay in your body longer). Renal means the same as kidney so the word kidney will be used throughout this
consent form. The sponsor of this study is Allos Therapeutics, Inc. (Allos) and the investigational drug is called pralatrexate. Pralatrexate blocks how cells are made and therefore the growth of a tumor may be slowed,
stopped, or the tumor size decreased. More than 600 adult cancer patients have received pralatrexate for various types of solid tumor and hematologic cancers (cancers that affect blood, bone marrow, and lymph
nodes) in clinical trials. Pralatrexate has not been approved by any health authority for the treatment of advanced solid tumor, lymphoma, or myeloma in patients who also have kidney impairment, but it is approved for marketing by the United States Food and Drug Administration (FDA) for patients with relapsed
or refractory peripheral T-cell lymphoma (PTCL) who have normal kidney function. It has not been approved for marketing by the European Medicines Agency (EMEA), or any other regulatory agencies. This means that pralatrexate has not been formally tested in patients with kidney impairment.
This study is being conducted to find out how impaired kidney function affects how well the body is able to get rid of pralatrexate and how pralatrexate is tolerated by patients with varying degrees of kidney function.
You are being asked to take part in this study because you have an advanced solid tumor that has gotten worse after or has not responded to at least one prior chemotherapy treatment. You may have normal kidney function or various levels of impaired kidney function to be in this study.
More Information:
Internal Protocol Documents (requires Siteman administrative database password)