A Phase 1-2, XIAP Antisense AEG35156 With Gemcitabine in Patients With Advanced Pancreatic Cancer

Exclusion Criteria

• •Prior chemotherapy for pancreatic cancer, except for 5-fluorouracil or gemcitabine given as a radiosensitizer
• •Active progressive brain metastases including the presence of any related symptoms or need for corticosteroids. A CT or MRI scan of the head is necessary in patients with a history of brain metastases to document the stability of prior lesions.
• •Known bleeding diathesis or concurrent treatment with anticoagulants except patients on non-therapeutic line maintenance coumadin
• •Pregnant or nursing women. NOTE: Women of child-bearing potential must agree to use adequate contraception (sterile or surgically sterile; hormonal or barrier method of birth control; or abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately
• •Men who are unwilling to use acceptable forms of birth control when engaging in sexual contact with women of child bearing potential
• •Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy
• •Known infection with HIV, hepatitis B, or hepatitis C
• •Serious nonmalignant disease that could compromise protocol objectives in the opinion of the investigator and/or the sponsor
• •Patients who are currently receiving any other investigational agent. Subjects who have used a previous antisense oligonucleotide in the last 90 days will be excluded
• •Unwillingness or inability to comply with procedures required in this protocol