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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00363610
Other study ID # EZ-002-001
Secondary ID
Status Terminated
Phase Phase 1
First received August 9, 2006
Last updated May 16, 2008
Start date July 2006
Est. completion date June 2008

Study information

Verified date May 2008
Source Enzon Pharmaceuticals, Inc.
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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®.


Description:

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.


Recruitment information / eligibility

Status Terminated
Enrollment 19
Est. completion date June 2008
Est. primary completion date November 2007
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Capable of understanding the protocol requirements and risks and providing written informed consent.

- Histologically or cytologically confirmed diagnosis of advanced and/or metastatic solid tumor or lymphoma (Hodgkin's or non-Hodgkin's), and have either failed primary treatment or there is no available standard treatment.

- Prior standard therapy was not effective, or no known therapy will extend survival or provide benefit.

- Measurable or evaluable disease.

- Age 18 years or older.

- Score of 0-2 on the Eastern Cooperative Oncology Group (ECOG) performance scale.

- Absolute neutrophil count (ANC)= 1500/µL.

- Platelet count = 100,000/µL.

- Hemoglobin = 9.0 g/dL.

- Fibrinogen = 0.75x the lower limit of normal (LLN), and PT, PTT, and INR = 1.5x the upper limit of normal (ULN).

- Serum creatinine = 1.5 mg/dL or creatinine clearance = 60 mL/min.

- Total bilirubin = 1.5 mg/dL.

- Transaminases (AST, ALT) = 2.5x the upper limit of normal (ULN) (may be = 5.0x ULN if due to metastatic disease in the liver).

- Amylase and lipase levels are within normal limits.

Any subject who has given informed consent to participate in the clinical study and who meets all entry criteria for the study may participate in the tumor analysis part of the study.

Exclusion Criteria:

- Subjects meeting any of the following exclusion criteria will not be eligible for enrollment.

- Concurrent serious medical illness that could potentially interfere with protocol compliance.

- Has pancreatitis or a history of pancreatitis, not related to pancreatic cancer.

- Has a coagulopathy or a history of coagulopathy.

- Known chronic infectious disease, such as AIDS or hepatitis (screening for hepatitis and HIV will not be performed).

- Positive screening pregnancy test or is breast-feeding.

- Female or male subject of reproductive capacity unwilling to use methods appropriate to prevent pregnancy during the course of this protocol.

- Known or clinically suspected active brain metastases.

- Received pegaspargase (Oncaspar®, PEG-L-asparaginase) or any asparaginase or asparaginase-containing drug, at any time prior to this study.

- Received prior chemotherapy, immunotherapy or an investigational agent regimen

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Oncaspar & Gemzar; advanced and/or solid tumors and lymphoma


Locations

Country Name City State
United States University of Nebraska Medical Center Omaha Nebraska
United States Cancer Therapy & Research Center, Institute for Drug Development San Antonio Texas
United States TGen Clinical Research Services at Scottsdale Healthcare Scottsdale Arizona

Sponsors (1)

Lead Sponsor Collaborator
Enzon Pharmaceuticals, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary and to determine the recommended Phase 2 dose of pegaspargase
Secondary The secondary objectives of this study are to evaluate the safety and tolerability of the combination study treatment
Secondary to determine the PD/PK profile and immunogenicity of pegaspargase
Secondary to determine the PK profile of gemcitabine when administered in combination with pegaspargase
Secondary and to detect preliminary evidence of tumor
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