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

• Status: Terminated
• Trial end date: 2009-11-01
• Target enrollment: 0
• Participant gender: All

Summary

This is an open-label multicenter, phase 1-2 study. Following determination of the recommended AEG35156 dose in combination with gemcitabine in the initial Phase 1 part of this study, additional patients will be enrolled in the Phase 2 part of the study to assess the activity of the combination first-line in advanced pancreatic cancer.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Aegera Therapeutics
• Treatments: Gemcitabine; X-Linked Inhibitor of Apoptosis Protein

Criteria

Inclusion Criteria:

• Patients with histologically or cytologically confirmed advanced pancreatic adenocarcinoma who are candidates for first-line gemcitabine therapy

• Karnofsky performance >70%

• One or more metastatic tumors measurable by RECIST criteria on CT scan or MRI (Phase 2 part only)

• Life expectancy of at least 3 months

• Age > 18 years

• Signed, written IRB-approved informed consent

• A negative serum pregnancy test (if applicable)

• Acceptable liver function:

• Bilirubin < 1.5 times the institution's upper limit of normal

• AST (SGOT), ALT (SGPT) and Alkaline phosphatase < 2.5 times the institution's upper limit of normal

• Acceptable renal function:

• Serum creatinine within normal limits, OR calculated creatinine clearance > 60 mL/min/1.73 m2 for patients with creatinine levels above institutional normal

• Acceptable hematologic status:

• Granulocyte > 1500 cells/uL

• Platelet count > 100,000 plt/uL

• Hemoglobin > 9.0 g/dL

• Acceptable coagulation status:

• PT within normal limits

• PTT within normal limits

• For women of child-producing potential, the use of effective contraceptive methods during the study

• Prior radiotherapy for local disease is allowed provided disease progression has been documented, and treatment completed at least 4 weeks prior to registration

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