EUCTR2007-007081-38-PT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 135 人开始时间: 2008年12月23日最近更新:
适应症
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
- 135
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 version 1.1 (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 as
- •a. Bone Marrow: absolute neutrophil count (ANC) = 1,500/mm3
- •(1.5 × 109/L); platelets = 100,000/mm3 (100 × 109/L); hemoglobin
- •= 9.0 g/dL (1.4 mmol/L);
- •b. Renal function: serum creatinine = 2.0 mg/dL (0.177 mmol/L);
- •c. Hepatic function: AST and ALT = 1.5 × ULN unless liver metastases are
- •present, then AST and ALT = 5.0 × ULN; bilirubin = 1.5 mg/dL
- •(0.026 mmol/L).
- •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 more than one prior therapy in the metastatic setting.
- •Lead-in Cohort only: The subject may have received more than one prior therapy
- •in the metastatic setting.
- •2. The subject has received cytotoxic chemotherapy (i.e. alkylating agents,
- •microtubule inhibitors, anti-metabolites) within 21 days prior to Study Day 1.
- •3. 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, sorafenib) or biologic
- •4. The subject has not recovered to less than or equal to Grade 1 clinically significant
- •adverse effects/toxicities of the previous therapy.
- •5. The subject has received prior treatment with a tyrosine kinase inhibitor targeting
- •VEGF or PDGF.
- •6. The subject has received prior treatment for colorectal cancer with oxaliplatin in
- •the metastatic setting. Lead-in cohort only: Prior treatment with oxaliplatin will
- •be allowed provided that any neuropathy as a result of the oxaliplatin treatment has
- •resolved to less than or equal to Grade 1.
- •7. The subject has had major surgery within 28 days of Study Day 1.
- •8. The subject has had radiotherapy within 14 days of Study Day 1.
- •9. 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).
- •10. The subject has a history of hypersensitivity to recombinant murine monoclonal
- •antibodies, oxaliplatin or other platinum-containing compounds, 5-fluorouracil, or
- •folinic acid.
- •11. The subject has proteinuria CTC grade > 1 at baseline as measured by a urine
- •dipstick and confirmed by a 24-hour urine collection.
- •12. The subject is receiving therapeutic anticoagulation therapy. Low dose
- •anticoagulation (e.g., low dose warfarin) for catheter prophylaxis will be
- •13. 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.
- •14. The subject currently exhibits symptomatic or persistent, uncontrolled
- •hypertension defined as diastolic blood pressure (BP) > 90 mmHg; or systolic
- •blood pressure (BP) > 140 mmHg. Subjects may be re-screened if blood pressure
- •is shown to be controlled with or without intervention.
- •15. The subject has a history of myocardial infarction, stroke, or transient ischemic
- •attack (TIA) within six months of Study Day 1.
- •16. The subject has a history of abdominal fistula or gastrointestinal perforation within
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