EUCTR2007-007081-38-GR进行中（未招募）不适用
An Open-Label, Randomized Phase 2 Study of ABT-869 in Combination With mFOLFOX6 (Oxaliplatin, 5-Fluorouracil, and Folinic Acid) Versus Bevacizumab in Combination With mFOLFOX6 as Second-line Treatment of Subjects With Advanced Colorectal Cancer
Abbott GmbH & Co KG0 个研究点目标入组 90 人开始时间: 2009年2月20日最近更新:
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 90
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
- 性别
- All
入选标准
- •1. The subject must be = 18 years of age.
- •2. The subject must be diagnosed with adenocarcinoma of the colon or rectum.
- •3. The subject must have metastatic disease or locally recurrent disease that is not
- •amenable to surgical resection with curative intent.
- •4. The subject must have received one prior chemotherapy regimen containing
- •irinotecan or a fluoropyrimidine for locally recurrent or metastatic colorectal
- •cancer. The subject has experienced progressive disease during or following the
- •prior chemotherapy treatment.
- •5. The subject may have received prior adjuvant treatment for colorectal cancer.
- •6. The subject has measurable disease, defined as at least 1 unidimensionally
- •measurable lesion on a CT scan as defined by RECIST (for subjects in the
- •randomized portion only).
- •7. The subject has an Eastern Cooperative Oncology Group (ECOG) performance
- •score of 0-1.
- •8. The subject must have adequate bone marrow, renal and hepatic function. Please refer to Section 5.2.1 of the study protocol for further information.
- •9. The subject must have PTT = 1.5 × ULN and INR = 1.5.
- •10. Female subjects of childbearing potential must have a negative urine pregnancy
- •test within 7 days prior to initiation of treatment, must be surgically sterile and/or
- •post menopausal women must be amenorrheic for at least 12 months to be
- •considered of non-childbearing potential. Female subjects of childbearing
- •potential and male subjects must agree to use adequate contraception (one of the following listed below) prior to study entry, for the duration of study participation and up to two months following completion of therapy.
- •? Total abstinence from sexual intercourse (minimum one complete menstrual
- •? A vasectomized partner;
- •? Hormonal contraceptives (oral, parenteral or transdermal) for at least
- •3 months prior to study drug administration;
- •? Double-barrier method (condoms, contraceptive sponge, diaphragm or vaginal
- •ring with spermicidal jellies or cream).
- •11. The subject is capable of understanding and complying with parameters as
- •outlined in the protocol and able to sign and date the informed consent, approved
- •by an Independent Ethics Committee (IEC)/Institutional Review Board (IRB),
- •prior to the initiation of any screening or study-specific procedures.
- •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
- •1. The subject has received cytotoxic chemotherapy (i.e. alkylating agents,
- •microtubule inhibitors, anti-metabolites) within 21 days prior to Study Day 1.
- •2. The subject has received non-cytotoxic, anti-cancer therapy within 21 days or
- •within a period defined by 5 half lives whichever is shorter, prior to study drug
- •administration. Anti-cancer therapies include, but are not limited to:
- •investigational agents (any agent not approved for use in humans),
- •immunotherapy, anti-cancer traditional Chinese medicine/herbal remedies,
- •hormonal, targeted agents (i.e., erlotinib, imatinib) or biologic therapy.
- •3. The subject has not recovered to less than or equal to Grade 1 clinically significant
- •adverse effects/toxicities of the previous therapy.
- •4. The subject has received prior treatment with bevacizumab or a tyrosine kinase
- •inhibitor targeting VEGF or PDGF. Lead-in cohort only: Prior treatment with
- •bevacizumab will be allowed, but not within 7 weeks of ABT-869 administration.
- •5. The subject has received prior treatment for colorectal cancer with oxaliplatin in
- •the metastatic setting.
- •6. The subject has had major surgery within 28 days of Study Day 1.
- •7. The subject has had radiotherapy within 14 days of Study Day 1.
- •8. The subject has symptomatic or untreated brain or meningeal metastases. CT
- •scans are not required to rule out brain or meningeal metastases unless there is a
- •clinical suspicion of central nervous system disease. Subjects with treated brain
- •metastases that are radiographically or clinically stable for at least 4 weeks after
- •therapy and have no evidence of cavitation or hemorrhage in the brain lesion are
- •eligible providing that they are asymptomatic and do not require corticosteroids
- •(must have discontinued steroids at least 1 week prior to study drug
- •administration).
- •9. The subject has a history of hypersensitivity to recombinant murine monoclonal
- •antibodies, oxaliplatin or other platinum-containing compounds, 5-fluorouracil, or
- •folinic acid.
- •10. The subject has proteinuria CTC grade > 1 at baseline as measured by a UPCR
- •of > 1 and confirmed by a 24-hour urine collection.
- •11. The subject is receiving therapeutic anticoagulation therapy. Low dose
- •anticoagulation (e.g., low dose warfarin) for catheter prophylaxis will be permitted.
- •12. The subject has a history of, or currently exhibits, clinically significant cancer
- •related events of bleeding (e.g., gross hemoptysis defined as bright red blood of at least ½ teaspoon or 2.5 mL per episode within three months prior to Study Day 1 unless definitively treated with surgery or radiation) or the subject has a recent
- •history of (within four weeks of Study Day 1) or currently exhibits other clinically
- •significant signs of bleeding.
- •13. The subject currently exhibits symptomatic or persistent, uncontrolled
- •hypertension defined as diastolic blood pressure (BP) > 100 mmHg; or systolic
- •blood pressure (BP) > 150 mmHg. Subjects may be re-screened if blood pressure
- •is shown to be controlled with or without intervention.
- •14. The subject has a history of myocardial infarction, stroke, or transient ischemic
- •attack (TIA) within six months of Study Day 1.
- •15. The subject has a history of abdominal fistula or gastrointestinal perforation within six months prior to Study Day 1.
- •16. The subject has a documented left ventricular (LV) ejection fraction < 50%.
- •17. The subject has known autoimmune disease with renal involvement (e.g., lupus).
- •18. The subject is receiving combination anti-retroviral therapy
研究者
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