A Multicenter, Open-Label, Phase I Study Evaluating the Safety and Tolerability of Intravenous Pegaspargase in Combination With Intravenous Gemcitabine HCl in the Treatment of Advanced and/or Metastatic Solid Tumors and Lymphoma
The purpose of this research study is for the study's sponsor, Enzon Pharmaceuticals, Inc.
("Enzon"), to learn more about its drug pegaspargase. Pegaspargase is the drug's scientific
or generic name. Because it is already approved by the Food and Drug Administration (FDA),
it also has a brand name - ONCASPAR®. It is approved by the FDA for the treatment of a type
of leukemia (cancer of white blood cells). However, pegaspargase is not approved by the FDA
for treatment of the cancer in this study. This study will research the side effects of
pegaspargase when it is used with another FDA-approved cancer treatment (chemotherapy) drug
called gemcitabine HCl; its brand name is GEMZAR®. It is approved for the treatment of
patients with cancer of the pancreas and of patients with breast cancer. However,
gemcitabine is not approved by the FDA for treatment of any other types of cancer.
In addition, the combination of pegaspargase and gemcitabine for solid tumors and lymphoma
in this study is investigational. This type of study treatment is called a "combination
treatment" or a "combination study." The information (research data) from this study will
be used by Enzon to plan other "combination" research studies with pegaspargase plus
gemcitabine for the treatment of certain cancers.
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
The primary objectives of this Phase 1 study of pegaspargase in combination with gemcitabine are to determine the maximum tolerated dose of IV pegaspargase when administered with gemcitabine
United States: Food and Drug Administration
|University of Nebraska Medical Center||Omaha, Nebraska 68198-3330|
|TGen Clinical Research Services at Scottsdale Healthcare||Scottsdale, Arizona 85258|
|Cancer Therapy & Research Center, Institute for Drug Development||San Antonio, Texas 78229|