AVN944 in Combination With Gemcitabine for the Treatment of Pancreatic Cancer

Pancreatic Cancer Clinical Trial

Official title:

A Phase II Study of AVN944 in Combination With Gemcitabine for the Treatment of Pancreatic Cancer

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00493441
• Other study ID #: AVN944-006
• Status: Terminated
• Phase: Phase 2
• Start date: June 2007
• Est. completion date: December 2009

Study information

• Verified date: September 2020
• Source: Vertex Pharmaceuticals Incorporated
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 information / eligibility

• Status: Terminated
• Enrollment: 28
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

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

Related Conditions & MeSH terms

• Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

Drug:
• AVN944
150, 200, 250, 300, or 400 mg q12h

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Vertex Pharmaceuticals Incorporated

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety		4 weeks
Primary	Pharmacokinetics		Days 1, 8, 15, and 22