EUCTR2007-005961-36-GB进行中（未招募）1 期
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
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 40
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •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
排除标准
- •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.
研究者
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