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


Phase 2
18 Years
N/A
Not Enrolling
Both
Pancreatic Cancer

Thank you

Trial Information

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


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 forthe 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 intra-epithelial 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 intra-ventricular 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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Safety

Outcome Time Frame:

4 weeks

Safety Issue:

Yes

Authority:

United States: Food and Drug Administration

Study ID:

AVN944-006

NCT ID:

NCT00493441

Start Date:

June 2007

Completion Date:

December 2009

Related Keywords:

  • Pancreatic Cancer
  • Pancreatic Neoplasms

Name

Location

University of Nebraska Medical CenterOmaha, Nebraska  68198-3330
Arizona Clinical Research CenterTucson, Arizona  85712
Columbia UniversityNew York, New York  10032-3784
Yale UniversityNew Haven, Connecticut  06520
California Pacific Medical Center Research InstituteSan Francisco, California  94115
Virginia Cancer InstituteRichmond, Virginia  23230
Chattanooga Oncology and Hematology AssociatesChattanooga, Tennessee  37404
Emory University - Winship Cancer InstituteAtlanta, Georgia  30322-1013
University of Tennessee Medical CenterKnoxville, Tennessee  37920
Hematology Oncology Associates of RocklandNyack, New York  10960
University of Southern California - Norris Comprehensive Cancer CenterLos Angeles, California  90033
Georgetown University, Lombardi Comprehensive Cancer CenterWashington, District of Columbia  20007
University of Florida - Shands Cancer CenterGainesville, Florida  32610
Joliet Oncology and Hematology AssociatesJoliet, Illinois  60435
Cleveland Clinic - Taussig Cancer CenterCleveland, Ohio  44195
Sarah Cannon Research Institute -Tennessee OncologyNashville, Tennessee  37203