AVN944 in Combination With Gemcitabine for the Treatment of Pancreatic Cancer

Phase 2

Terminated

Brief Summary: The study was designed to 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 was more effective for treating pancreatic cancer than using gemcitabine alone.

Recruitment & Eligibility

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 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 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 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

Arm && Interventions

Group	Intervention	Description
Treatment	AVN944	-

Primary Outcome Measures

Name	Time	Method
Pharmacokinetics	Days 1, 8, 15, and 22
Safety	4 weeks

Secondary Outcome Measures

Name	Time	Method

Locations (16): Emory University - Winship Cancer Institute
🇺🇸
Atlanta, Georgia, United States
Cleveland Clinic - Taussig Cancer Center
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Cleveland, Ohio, United States
California Pacific Medical Center Research Institute
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San Francisco, California, United States
Sarah Cannon Research Institute -Tennessee Oncology
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Nashville, Tennessee, United States
University of Nebraska Medical Center
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Omaha, Nebraska, United States
University of Florida - Shands Cancer Center
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Gainesville, Florida, United States
Arizona Clinical Research Center
🇺🇸
Tucson, Arizona, United States
Yale University
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New Haven, Connecticut, United States
University of Southern California - Norris Comprehensive Cancer Center
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Los Angeles, California, United States
University of Tennessee Medical Center
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Knoxville, Tennessee, United States
Hematology Oncology Associates of Rockland
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Nyack, New York, United States
Chattanooga Oncology and Hematology Associates
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Chattanooga, Tennessee, United States
Joliet Oncology and Hematology Associates
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Joliet, Illinois, United States
Georgetown University, Lombardi Comprehensive Cancer Center
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Washington, District of Columbia, United States
Columbia University
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New York, New York, United States
Virginia Cancer institute
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Richmond, Virginia, United States