The study will find the optimum AVN944 dose to use in combination with gemcitabine in
patients with pancreatic cancer and see if the combination of the 2 drugs is more effective
for treating pancreatic cancer than using gemcitabine alone.
Inclusion Criteria:
- Patients with histologically or cytologically confirmed adenocarcinoma of the pancreas
not eligible for curative intent resection with or without adjuvant radiation therapy
- 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 forthe 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 a life expectancy < 3 months
- 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 intra-epithelial 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 intra-ventricular 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
Arizona Clinical Research Center, Tuscon, Arizona 85715, United States; Recruiting
Patricia Plezia, PharmD, Phone: 520-290-2510, Email: pplezia@acrcresearch.com
Manuel Modiano, MD, Principal Investigator
Pivotal Research Center, Peoria, Arizona 85381, United States; Not yet recruiting
Julie Herrera, Phone: 866-788-3921, Email: jherrera@pivotalresearch.com
Divis Khaira, Principal Investigator
California Pacific Medical Center Research Institute, San Francisco, California 94115, United States; Recruiting
Jamie Schmidt, Phone: 415-600-1182, Email: schmidj@cpmri.org
Ari Baron, MD, Principal Investigator
University of Southern California - Norris Comprehensive Cancer Center, Los Angeles, California 90033, United States; Not yet recruiting
Carolyn Castellanos, Phone: 323-865-3967, Email: Castellanos_c@ccnt.usc.edu
Heinz Josef-Lenz, MD, Principal Investigator
Yale University, New Haven, Connecticut 06520, United States; Recruiting
Lynne Lamb, Phone: 203-737-2562, Email: lynne.lamb@yale.edu
Wasif Saif, MD, Phone: 203-737-1569, Email: wasif.saif@yale.edu
Wasif Saif, MD, Principal Investigator
Georgetown University, Lombardi Comprehensive Cancer Center, Washington, District of Columbia 20007, United States; Recruiting
Lisa Ley, Phone: 202-687-6653, Email: LeyL@georgetown.edu
John Marshall, MD, Principal Investigator
University of Florida - Shands Cancer Center, Gainesville, Florida 32610, United States; Not yet recruiting
Tracy Borchardt, Phone: 352-392-0517, Email: tborchar@ufl.edu
Thomas George, MD, Principal Investigator
Emory University - Winship Cancer Institute, Altanta, Georgia 30322, United States; Not yet recruiting
Shequila Harper, Phone: 404-778-4449, Email: shequila.harper@emoryhealthcare.org
John Kauh, MD, Principal Investigator
Joliet Oncology and Hematology Associates, Joliet, Illinois 60435, United States; Not yet recruiting
Karen Sceniak, Phone: 815-730-3098, Email: ksceniak@jolietoncology.com
Sanjiv Modi, MD, Principal Investigator
University of Nebraska Medical Center, Omaha, Nebraska 68198, United States; Recruiting
Lacey Frank, Phone: 402-559-8874, Email: lfrank@unmc.edu
Jean Grem, MD, Principal Investigator
Columbia University, New York, New York 10032, United States; Not yet recruiting
Mary Ann Kral, Phone: 212-305-7266, Email: mak71@columbia.edu
Michael Hall, MD, Principal Investigator
Hematology Oncology Associates of Rockland, Nyack, New York 10960, United States; Not yet recruiting
Martha Brahms, Phone: 845-362-1750, Email: Arbrahms2@aol.com
Brad Cohen, MD, Principal Investigator
Cleveland Clinic - Taussig Cancer Center, Cleveland, Ohio 44195, United States; Not yet recruiting
Patricia Weiss, RN, Phone: 800-223-2273, Email: weissp@ccf.org
Richard Kim, MD, Principal Investigator
Sarah Cannon Research Institute -Tennessee Oncology, Nashville, Tennessee 37203, United States; Not yet recruiting
Jennifer Thompson, Phone: 615-329-7275, Email: jennifer.thompson@scresearch.net
Jeffrey Infante, Principal Investigator
University of Tennessee Medical Center, Knoxville, Tennessee 37920, United States; Not yet recruiting
Barbara Munsey, Phone: 865-305-9773, Email: bmunsey@utmck.edu
Wahid Hanna, MD, Principal Investigator
Chattanooga Oncology and Hematology Associates, Chattanooga, Tennessee 37404, United States; Not yet recruiting
Melissa Claxton, Phone: 423-632-1844, Email: melissaclaxton@cohaonline.com
Edward Arrowsmith, MD, Principal Investigator
Virginia Cancer institute, Richmond, Virginia 23230, United States; Not yet recruiting
Sue Moore, Phone: 804-287-3000, Email: smoore@vacancer.com
David Trent, MD, Principal Investigator
