A Phase 1-2, Multicenter, Open-Label Study of The X-Linked Inhibitor of Apoptosis (XIAP) Antisense AEG35156 Given in Combination with Gemcitabine in Patients with Advanced Pancreatic Cancer
- Conditions
- Advanced pancreatic adenocarcinomaMedDRA version: 9.1 Level: LLT Classification code 10033599 Term: Pancreatic adenocarcinoma metastatic
- Registration Number
- EUCTR2007-005961-36-GB
- Lead Sponsor
- Aegera Therapeutics Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 40
Patients with histologically or cytologically confirmed advanced pancreatic adenocarcinoma who are candidates for first-line gemcitabine therapy
Karnofsky performance greater than or equal to 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 greater than or equal to 18 years
Signed, written IRB-approved informed consent
A negative serum pregnancy test
Acceptable liver function: 1) Total bilirubin less than or equal to 1.5 times the Institution's upper limit of normal (ULN), 2) AST (SGOT) and ALT (SGPT) less than or equal to 2.5 x ULN or less than or equal to 5 x ULN if there are documented liver metastases
Acceptable renal function: Serum creatinine within normal limits, OR calculated creatinine clearance greater than or equal to 60 mL/min/1.73 m2 for patients with creatinine levels above institutional normal
Acceptable hematologic status: 1) Granulocyte greater than or equal to 1500 cells/microlitre, 2) Platelet count greater than or equal to 100,000 plt/microlitre, 3) Hemoglobin greater than or equal to 9.0 g/dL
Acceptable coagulation status: 1) PT within normal limits, 2) PTT within normal limits
For women of child-producing potential, the use of effective contraceptive methods during the study
Prior radiothrerapy for local disease is allowed provided disease progression has been documented, and treatment completed at least 4 weeks prior to registration.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
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-therapuetic line mantenance 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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method