AVN944 in Combination With Gemcitabine for the Treatment of Pancreatic Cancer
NCT ID: NCT00493441
Last Updated: 2020-09-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE2
28 participants
INTERVENTIONAL
2007-06-30
2009-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Treatment
AVN944
150, 200, 250, 300, or 400 mg q12h
Interventions
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AVN944
150, 200, 250, 300, or 400 mg q12h
Eligibility Criteria
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Inclusion Criteria
* Measurable disease as defined by RECIST criteria
* No prior chemotherapy for pancreatic cancer including no prior "radiosensitizing" chemotherapy
* Patients are candidates to receive gemcitabine as first line treatment for adenocarcinoma of the pancreas
* Age \> 18 years
* Karnofsky Performance Score of less than or equal to 60
* Patients must be recovered from the clinically significant effects of any prior surgery or prior radiotherapy
* Adequate bone marrow, hepatic and renal function as evidenced by:
* Serum total bilirubin \< 2.0 mg/dL
* AST/ALT (SGOT/SGPT) \< 4X the ULN for the reference lab;
* Serum creatinine \< 2.0 mg/dL;
* ANC \> 1.5 x 109/L;
* Platelet count \> 100 x 109/L,
* Hgb \> 9.0 g/dL
* Female patients of childbearing potential as well as fertile men and their partners who agree to use an effective form of contraception during the study and for 90 days following the last dose of study medication (an effective form of contraception is an oral contraceptive or a double barrier method)
* Patients or their legal representatives must be able to read, understand and provide written informed consent to participate in the trial.
Exclusion Criteria
* Patients with known CNS metastases
* Patients with an uncontrolled active infection
* Prior treatment with an IMPDH-inhibitor
* Patients with known hypersensitivity to any of the components of AVN944 or gemcitabine
* History of prior malignancy within the past 5 years except for curatively treated non-melanoma skin cancers; cervical intraepithelial neoplasia, or localized prostate cancer with a current PSA of \< 1.0 mg/dL
* Patients who are receiving concurrent investigational therapy or who have received investigational therapy within 14 days of the first scheduled day of dosing (investigational therapy is defined as treatment for which there is currently no regulatory authority approved indication). Clinically significant toxicities from this therapy must have resolved to \< Grade 2.
* Patients who are pregnant or lactating
* Myocardial Infarction within the past 6 months
* Patients with clinically significant intraventricular conduction delays
* Any other intercurrent medical condition, including mental illness or substance abuse, deemed by the Investigator to be likely to interfere with a patient's ability to sign informed consent, cooperate and participate in the study, or interfere with the interpretation of the results.
* History of solid organ transplant
* Known HIV or Hepatitis B or C (active, previously treated or both)
* Previous treatment under this protocol
18 Years
ALL
No
Sponsors
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Vertex Pharmaceuticals Incorporated
INDUSTRY
Responsible Party
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Locations
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Arizona Clinical Research Center
Tucson, Arizona, United States
University of Southern California - Norris Comprehensive Cancer Center
Los Angeles, California, United States
California Pacific Medical Center Research Institute
San Francisco, California, United States
Yale University
New Haven, Connecticut, United States
Georgetown University, Lombardi Comprehensive Cancer Center
Washington D.C., District of Columbia, United States
University of Florida - Shands Cancer Center
Gainesville, Florida, United States
Emory University - Winship Cancer Institute
Atlanta, Georgia, United States
Joliet Oncology and Hematology Associates
Joliet, Illinois, United States
University of Nebraska Medical Center
Omaha, Nebraska, United States
Columbia University
New York, New York, United States
Hematology Oncology Associates of Rockland
Nyack, New York, United States
Cleveland Clinic - Taussig Cancer Center
Cleveland, Ohio, United States
Chattanooga Oncology and Hematology Associates
Chattanooga, Tennessee, United States
University of Tennessee Medical Center
Knoxville, Tennessee, United States
Sarah Cannon Research Institute -Tennessee Oncology
Nashville, Tennessee, United States
Virginia Cancer institute
Richmond, Virginia, United States
Countries
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Other Identifiers
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AVN944-006
Identifier Type: -
Identifier Source: org_study_id
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