EUCTR2007-007081-38-CZ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9月2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 six mon
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