Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsored by: |
Abraxis BioScience Inc. |
---|---|
Information provided by: | Abraxis BioScience Inc. |
ClinicalTrials.gov Identifier: | NCT00398086 |
To determine the MTD and DLT of Gemcitabine plus ABI-007 in patients with advanced metastatic pancreatic cancer
Condition | Intervention | Phase |
---|---|---|
Metastatic Pancreatic Cancer |
Drug: ABI-007 plus Gemcitabine |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Phase I Trial of Gemcitabine (Gemzar) Plus ABI-007 (ABRAXANE) In Patients With Advanced Metastatic Pancreatic Cancer |
Enrollment: | 67 |
Study Start Date: | November 2006 |
Estimated Study Completion Date: | February 2010 |
Primary Completion Date: | September 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental |
Drug: ABI-007 plus Gemcitabine
3 patients entered at low dose A, If no DLT-3 more patients enrolled at dose B Number of cycles:until progression or inacceptable toxicity develops
|
ABI-007 is a novel, solvent-free, albumin-bound, 130 nanometer particle form of paclitaxel designed to avoid the problems associated with solvents used in Taxol(Abraxane prescribing information 2005). Albumin has a number of properties that make it an attractive molecule to combine with paclitaxel. Albumin is a natural transporter of endogenous hydrophobic molecules such as water-insoluble vitamins and hormones (Vorum 1999)and albumin binding to the gp-60 receptor (albondin) initiates the caveolae-mediated endothelial transport of protein-bound and unbound plasma constituents (John et al 2003, Minshall et al 2003, Tiruppathi et al 1997).
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Alabama | |
University of Alabama at Birmingham Comprehensive Cancer Ctr | |
Birmingham, Alabama, United States | |
United States, Arizona | |
Scottsdale Healthcare/Virginia Pipe Cancer Institute | |
Scottsdale, Arizona, United States, 85258 | |
United States, Maryland | |
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins University | |
Baltimore, Maryland, United States, 35233 | |
United States, Minnesota | |
Virigina Piper Cancer Institute | |
Minneapolis, Minnesota, United States, 55407 | |
United States, Texas | |
South Texas Oncology & Hematology | |
San Antonio, Texas, United States, 78258 |
Principal Investigator: | Daniel VonHoff, MD | Scottsdale Clinical Research Institute |
Responsible Party: | Abraxis BioScience ( Amanda Johnson, Clinical Trials Manager ) |
Study ID Numbers: | CA040 |
Study First Received: | November 8, 2006 |
Last Updated: | June 8, 2009 |
ClinicalTrials.gov Identifier: | NCT00398086 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Metastatic Pancreatic Cancer, Abraxane, Gemcitabine |
Antimetabolites Anti-Infective Agents Digestive System Neoplasms Immunologic Factors Pancreatic Neoplasms Endocrine System Diseases Immunosuppressive Agents Antiviral Agents |
Digestive System Diseases Radiation-Sensitizing Agents Paclitaxel Gastrointestinal Neoplasms Pancreatic Diseases Endocrinopathy Gemcitabine Endocrine Gland Neoplasms |
Antimetabolites Anti-Infective Agents Digestive System Neoplasms Antimetabolites, Antineoplastic Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Pancreatic Neoplasms Physiological Effects of Drugs Endocrine System Diseases Enzyme Inhibitors |
Immunosuppressive Agents Antiviral Agents Pharmacologic Actions Neoplasms Neoplasms by Site Digestive System Diseases Radiation-Sensitizing Agents Therapeutic Uses Pancreatic Diseases Gemcitabine Endocrine Gland Neoplasms |