The FG-3019 treatment will be administered over a 28-day cycle:
* Dose: 35 mg/kg
* Route: IV over one hour following completion of gemcitabine infusion
* Schedule:
* Days 1, 8, and 15
* Please note that Day 8 infusion will on be completed during the first treatment cycle
On Drug Evaluation
The patient will be seen prior to every FG-3019 treatment by the treating physician. The following procedures will be conducted at each visit:
* History and thorough symptom assessment
* Physical examination
* Laboratory assessments (these can be collected up to 3 days prior to treatment):
* Complete blood count (CBC) and differential
* Comprehensive Metabolic Panel (Chemistry): bicarbonate, blood, urea, nitrogen (BUN), calcium, creatinine, glucose, potassium, sodium
* Liver Function Tests: Alkaline phosphatase (ALP), Alanine transaminase (ALT), Aspartate transaminase (AST), total bilirubin
* Carbohydrate antigen (CA) 19-9
ECGs will be conducted during the screening and end of treatment visits. CT scans of the chest and abdomen will be done every 12 to 16 weeks.
All of these data will be recorded and stored with their source documents.
