Ignite Creation Date:
2024-05-05 @ 5:01 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00363610
Status:
TERMINATED
Last Update Posted:
2008-05-20
First Post:
2006-08-09
Brief Title:
A Study Evaluating IV Oncaspar and IV Gemzar in the Treatment of Solid Tumors and Lymphoma
Sponsor:
Enzon Pharmaceuticals Inc
Organization:
Enzon Pharmaceuticals Inc
Study Overview
Official Title:
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 andor Metastatic Solid Tumors and Lymphoma
Status:
TERMINATED
Status Verified Date:
2008-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
No recommended Phase II dose was determined
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will research the side effects of pegaspargase pronounced peg-as-par-gase its brand name is ONCASPAR when it is used with another FDA-approved cancer treatment chemotherapy drug called gemcitabine HCl pronounced gem-site-a-bean its brand name is GEMZAR
Detailed Description:
The purpose of this research study is for the studys sponsor Enzon Pharmaceuticals Inc Enzon to learn more about its drug pegaspargase Pegaspargase is the drugs 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None