AVN944 In Combination With Gemcitabine For The Treatment Of Pancreatic Cancer

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2007-06-26	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2020-09-22
First Submitted that Met QC Criteria 2007-06-26	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2020-09-30
First Posted (ACTUAL) 2007-06-28	Results First Posted N/A	Last Verified 2020-09

Design Details

Primary Purpose:
Treatment

Allocation:
Non Randomized

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: Treatment	DRUG: AVN944 150, 200, 250, 300, or 400 mg q12h

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: Treatment

DRUG: AVN944

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

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

Secondary Outcome Measures	Measure Description	Time Frame

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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.

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

Collaborators and Investigators

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

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Resources

PatientS

Caregivers

Clinical Trial Record