AVN944 in Combination With Gemcitabine for the Treatment of Pancreatic Cancer

NCT00493441 | Terminated Phase 2 DMC

• 1 other identifier: AVN944-006
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 16

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.

Conditions

Pancreatic Cancer

Outcome Measures

Primary Outcomes (2)

• Safety

  4 weeks

• Pharmacokinetics

  Days 1, 8, 15, and 22

Study Arms (1)

Treatment

EXPERIMENTAL

Drug: AVN944

Interventions

AVN944 DRUG

150, 200, 250, 300, or 400 mg q12h

Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Vertex Pharmaceuticals Incorporated: lead

Study Sites (16)

Arizona Clinical Research Center

Tucson, Arizona, 85715, United States

Location

University of Southern California - Norris Comprehensive Cancer Center

Los Angeles, California, 90033, United States

Location

California Pacific Medical Center Research Institute

San Francisco, California, 94115, United States

Location

Yale University

New Haven, Connecticut, 06520, United States

Location

Georgetown University, Lombardi Comprehensive Cancer Center

Washington D.C., District of Columbia, 20007, United States

Location

University of Florida - Shands Cancer Center

Gainesville, Florida, 32610, United States

Location

Emory University - Winship Cancer Institute

Atlanta, Georgia, 30322, United States

Location

Joliet Oncology and Hematology Associates

Joliet, Illinois, 60435, United States

Location

University of Nebraska Medical Center

Omaha, Nebraska, 68198, United States

Location

Columbia University

New York, New York, 10032, United States

Location

Hematology Oncology Associates of Rockland

Nyack, New York, 10960, United States

Location

Cleveland Clinic - Taussig Cancer Center

Cleveland, Ohio, 44195, United States

Location

Chattanooga Oncology and Hematology Associates

Chattanooga, Tennessee, 37404, United States

Location

University of Tennessee Medical Center

Knoxville, Tennessee, 37920, United States

Location

Sarah Cannon Research Institute -Tennessee Oncology

Nashville, Tennessee, 37203, United States

Location

Virginia Cancer institute

Richmond, Virginia, 23230, United States

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

AVN 944

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 26, 2007
• First Posted: June 28, 2007
• Study Start: June 1, 2007
• Primary Completion: December 1, 2009
• Study Completion: December 1, 2009
• Last Updated: September 30, 2020

Record last verified: 2020-09

Locations

US (16)