AVN944 in Combination With Gemcitabine for the Treatment of Pancreatic Cancer

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Vertex Pharmaceuticals Incorporated
ClinicalTrials.gov Identifier:
NCT00493441
First received: June 26, 2007
Last updated: August 5, 2014
Last verified: September 2013
  Purpose

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.


Condition Intervention Phase
Pancreatic Cancer
Drug: AVN944
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Study of AVN944 in Combination With Gemcitabine for the Treatment of Pancreatic Cancer

Resource links provided by NLM:


Further study details as provided by Vertex Pharmaceuticals Incorporated:

Primary Outcome Measures:
  • Safety [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]
  • Pharmacokinetics [ Time Frame: Days 1, 8, 15, and 22 ] [ Designated as safety issue: No ]

Enrollment: 28
Study Start Date: June 2007
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment Drug: AVN944
150, 200, 250, 300, or 400 mg q12h

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00493441

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

No publications provided

Responsible Party: Vertex Pharmaceuticals Incorporated
ClinicalTrials.gov Identifier: NCT00493441     History of Changes
Other Study ID Numbers: AVN944-006
Study First Received: June 26, 2007
Last Updated: August 5, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Diseases
Digestive System Neoplasms
Endocrine Gland Neoplasms
Endocrine System Diseases
Neoplasms
Neoplasms by Site
Pancreatic Diseases
Gemcitabine
Anti-Infective Agents
Antimetabolites
Antimetabolites, Antineoplastic
Antineoplastic Agents
Antiviral Agents
Enzyme Inhibitors
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Radiation-Sensitizing Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 20, 2014