AVN944 in Combination With Gemcitabine for the Treatment of Pancreatic Cancer

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

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.

Study Overview

• Status: Terminated
• Conditions: Pancreatic Cancer
• Intervention / Treatment: Drug: AVN944

• Study Type: Interventional
• Enrollment (Actual): 28
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Tucson, Arizona, United States, 85715
      • Arizona Clinical Research Center
  • California
    • Los Angeles, California, United States, 90033
      • University of Southern California - Norris Comprehensive Cancer Center
    • San Francisco, California, United States, 94115
      • California Pacific Medical Center Research Institute
  • Connecticut
    • New Haven, Connecticut, United States, 06520
      • Yale University
  • District of Columbia
    • Washington, District of Columbia, United States, 20007
      • Georgetown University, Lombardi Comprehensive Cancer Center
  • Florida
    • Gainesville, Florida, United States, 32610
      • University of Florida - Shands Cancer Center
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Emory University - Winship Cancer Institute
  • Illinois
    • Joliet, Illinois, United States, 60435
      • Joliet Oncology and Hematology Associates
  • Nebraska
    • Omaha, Nebraska, United States, 68198
      • University of Nebraska Medical Center
  • New York
    • New York, New York, United States, 10032
      • Columbia University
    • Nyack, New York, United States, 10960
      • Hematology Oncology Associates of Rockland
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic - Taussig Cancer Center
  • Tennessee
    • Chattanooga, Tennessee, United States, 37404
      • Chattanooga Oncology and Hematology Associates
    • Knoxville, Tennessee, United States, 37920
      • University of Tennessee Medical Center
    • Nashville, Tennessee, United States, 37203
      • Sarah Cannon Research Institute -Tennessee Oncology
  • Virginia
    • Richmond, Virginia, United States, 23230
      • Virginia Cancer Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment	Drug: AVN944; 150, 200, 250, 300, or 400 mg q12h

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Safety	4 weeks
Pharmacokinetics	Days 1, 8, 15, and 22

Collaborators and Investigators

• Sponsor: Vertex Pharmaceuticals Incorporated

Study record dates

Study Major Dates

• Study Start: June 1, 2007
• Primary Completion (Actual): December 1, 2009
• Study Completion (Actual): December 1, 2009

Study Registration Dates

• First Submitted: June 26, 2007
• First Submitted That Met QC Criteria: June 26, 2007
• First Posted (Estimate): June 28, 2007

Study Record Updates

• Last Update Posted (Actual): September 30, 2020
• Last Update Submitted That Met QC Criteria: September 22, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Endocrine System Diseases; Digestive System Neoplasms; Endocrine Gland Neoplasms; Pancreatic Diseases; Pancreatic Neoplasms
• Other Study ID Numbers: AVN944-006