A Phase 2 Randomized, Placebo-Controlled, Double-Blind Study of ABT-869 in Combination With Paclitaxel Versus Paclitaxel Alone as First-line Treatment in Subjects With Locally Recurrent or Metastatic Breast Cancer

Abbott GmbH & Co. KG0 个研究点目标入组 90 人开始时间: 2008年6月18日最近更新: 2013年8月5日

适应症

试验速览

阶段: 不适用
状态: 进行中（未招募）
发起方: Abbott GmbH & Co. KG
入组人数: 90

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

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研究设计

研究类型: Interventional clinical trial of medicinal product

入排标准

性别: Female

入选标准

•1. The subject is female and = 18 years of age.
•2. The subject is diagnosed with adenocarcinoma of the breast.
•3. The subject must have metastatic disease or locally recurrent disease that is not
•amenable to local treatment (surgical or radiation) with curative intent.
•4. The subject must have received no prior chemotherapy for locally recurrent or
•metastatic breast cancer.
•5. At least 12 months have passed since the subject received prior adjuvant or
•neoadjuvant cytotoxic chemotherapy (including prior taxane therapy and prior
•anti-angiogenic therapy [i.e., bevacizumab or a TKI]).
•6. The subject does not have HER-2 –overexpression (3+) breast cancer (unless
•treated previously with trastuzumab [Herceptin] or lapatinib).
•7. 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).
•8. The subject has an Eastern Cooperative Oncology Group (ECOG) performance
•score of 0-1.
•9. 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 (0.81 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).
•10. The subject must have PTT = 1.5 × ULN and INR = 1.5.
•11. Women of childbearing potential must have a negative urine pregnancy test within 7 days prior to initiation of treatment and/or post menopausal women must be
•amenorrheic for at least 12 months to be considered of non-childbearing potential.
•Women of childbearing potential 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;
•? Double-barrier method (condoms, contraceptive sponge, diaphragm or vaginal
•ring with spermicidal jellies or cream).
•12. 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 anti-cancer therapy (other than chemotherapy) including
•investigational agents (any agent not approved for use in humans),
•immunotherapy, anti-cancer Chinese medicine/herbal remedies, or biologic
•therapy within 21 days or within a period defined by 5 half lives if the previous
•agent was a chronically dosed, targeted therapy (e.g., trastuzumab), whichever is
•shorter, prior to Study Day 1. Clinically significant adverse effects/toxicities of
•the previous therapy must have recovered to = Grade 1.
•2. The subject has had major surgery within 21 days of Study Day 1.
•3. The subject has received radiation therapy (including palliative radiation) within
•14 days of Study Day 1.
•4. The subject has received anti-cancer hormonal therapy (e.g., tamoxifen) within
•14 days of Study Day 1.
•5. 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 Day 1).
•6. The subject has hypersensitivity to paclitaxel or to other drugs formulated with
•polyethoxylated castor oil (Crempahor) not able to be controlled with medication.
•7. The subject has proteinuria CTC grade > 1 at baseline as measured by a UPC ratio
•of > 1 and confirmed by a 24-hour urine collection.
•8. The subject is receiving therapeutic anticoagulation therapy. Low dose
•anticoagulation (e.g., low dose warfarin) for catheter prophylaxis will be permitted.
•9. 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 3 months prior to randomization
•unless definitively treated with surgery or radiation) or the subject has a recent
•history of (within 4 weeks of Study Day 1) or currently exhibits other clinically
•significant signs of bleeding.
•10. 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.
•11. The subject has a history of myocardial infarction, stroke, or transient ischemic
•attack (TIA) within 6 months of Study Day 1.
•12. The subject has a documented left ventricular (LV) ejection fraction < 50%.
•13. The subject has known autoimmune disease with renal involvement (e.g., lupus).
•14. The subject is receiving combination anti-retroviral therapy for HIV.
•15. The subject is pregnant or breast-feeding.
•16. The subject has clinically significant uncontrolled condition(s) including but not
•limited to:
•active uncontrolled infection,
•symptomatic congestive heart failure,
•unstable angina pectoris or cardiac arrhythmia,
•history of adrenal insufficiency,
•psychiatric illness/social situation that would limit compliance with study requirements.
•17. The subject has active ulcerative colitis, Crohn's disease, celiac disease or any
•other conditions that interfere with absorption.
•18. The subject has had another

研究者

发起方

Abbott GmbH & Co. KG

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