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

Stopped early · Phase 1/Phase 2

Conditions studied: Carcinoma, Pancreas

In brief

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.

Key facts

Study ID: NCT00557596
Run by: Aegera Therapeutics
People needed: 48
Starts: 2007-09-01
Expected to finish: 2009-11-01
Last updated by the study team: 2009-12-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

Scottsdale Healthcare - SHEA — Scottsdale, Arizona, United States
Mayo Clinic Arizona — Scottsdale, Arizona, United States
Arizona Cancer Center - University of Arizona — Tucson, Arizona, United States
Gabrail Cancer Center — Canton, Ohio, United States

Full record on ClinicalTrials.gov

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