Clinical trial NCT00493441: AVN944 in Combination With Gemcitabine for the Treatment of Pancreatic Cancer
Official title: A Phase II Study of AVN944 in Combination With Gemcitabine for the Treatment of Pancreatic Cancer
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Pancreatic Cancer
Lead sponsor: Vertex Pharmaceuticals Incorporated
Sponsor class: INDUSTRY
First posted: 2007-06-28
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Safety
timeFrame: 4 weeks
measure: Pharmacokinetics
timeFrame: Days 1, 8, 15, and 22
Secondary outcomes:
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Arizona Clinical Research Center
state: Arizona
city: Los Angeles
country: United States
facility: University of Southern California - Norris Comprehensive Cancer Center
state: California
city: San Francisco
country: United States
facility: California Pacific Medical Center Research Institute
state: California
city: New Haven
country: United States
facility: Yale University
state: Connecticut
city: Washington
country: United States
facility: Georgetown University, Lombardi Comprehensive Cancer Center
state: District of Columbia
city: Gainesville
country: United States
facility: University of Florida - Shands Cancer Center
state: Florida
city: Atlanta
country: United States
facility: Emory University - Winship Cancer Institute
state: Georgia
city: Joliet
country: United States
facility: Joliet Oncology and Hematology Associates
state: Illinois
city: Omaha
country: United States
facility: University of Nebraska Medical Center
state: Nebraska
city: New York
country: United States
facility: Columbia University
state: New York
city: Nyack
country: United States
facility: Hematology Oncology Associates of Rockland
state: New York
city: Cleveland
country: United States
facility: Cleveland Clinic - Taussig Cancer Center
state: Ohio
city: Chattanooga
country: United States
facility: Chattanooga Oncology and Hematology Associates
state: Tennessee
city: Knoxville
country: United States
facility: University of Tennessee Medical Center
state: Tennessee
city: Nashville
country: United States
facility: Sarah Cannon Research Institute -Tennessee Oncology
state: Tennessee
city: Richmond
country: United States
facility: Virginia Cancer institute
state: Virginia
Study officials:
References: