Carcinoma Clinical Trial
Official title:
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
Verified date | November 2009 |
Source | Aegera Therapeutics |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 48 |
Est. completion date | November 2009 |
Est. primary completion date | November 2009 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Gabrail Cancer Center | Canton | Ohio |
United States | Mayo Clinic Arizona | Scottsdale | Arizona |
United States | Scottsdale Healthcare - SHEA | Scottsdale | Arizona |
United States | Arizona Cancer Center - University of Arizona | Tucson | Arizona |
Lead Sponsor | Collaborator |
---|---|
Aegera Therapeutics |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | To determine the recommended dose of AEG35156 when used in combination with gemcitabine and the change in response rate of gemcitabine in patients | 1 year | No | |
Secondary | To determine progression-free survival. | 2 years | No | |
Secondary | To establish the pharmacokinetics of AEG35156 and gemcitabine when used in combination. | 1 year | No |
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