NL-OMON32901撤回2 期
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 - ABT-869 in Breast Cancer
适应症
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 发起方
- Abbott
- 入组人数
- 8
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •- The subject is female and * 18 years of age.
- •- The subject is diagnosed with adenocarcinoma of the breast.
- •- The subject must have metastatic disease or locally recurrent disease that is not amenable to local treatment (surgical or radiation) with curative intent.
- •- The subject must have received no prior chemotherapy for locally recurrent or metastatic breast cancer.
- •- 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]).
- •- The subject does not have HER-2 *overexpression (3+) breast cancer (unless treated previously with trastuzumab [Herceptin] or lapatinib).
- •- 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).
- •- The subject has an Eastern Cooperative Oncology Group (ECOG) performance score of 0-1.
- •- The subject must have adequate bone marrow, renal and hepatic function
排除标准
- •- 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.
- •- The subject has had major surgery within 21 days of Study Day 1.
- •- The subject has received radiation therapy (including palliative radiation) within 14 days of Study Day 1.
- •- The subject has received anti-cancer hormonal therapy (e.g., tamoxifen) within 14 days of Study Day 1.
- •- The subject has symptomatic or untreated brain or meningeal metastases.
- •- The subject has hypersensitivity to paclitaxel or to other drugs formulated with polyethoxylated castor oil (Crempahor) not able to be controlled with medication.
- •- 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.
- •- The subject is receiving therapeutic anticoagulation therapy. Low dose anticoagulation (e.g., low dose warfarin) for catheter prophylaxis will be permitted.
- •- 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 * 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.
- •- 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.
- •- The subject has a history of myocardial infarction, stroke, or transient ischemic attack (TIA) within 6 months of Study Day 1.
- •- The subject has a documented left ventricular (LV) ejection fraction < 50%.
- •- The subject has known autoimmune disease with renal involvement (e.g., lupus).
- •- The subject is receiving combination anti-retroviral therapy for HIV.
- •- The subject is pregnant or breast-feeding.
- •- 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.
- •- The subject has active ulcerative colitis, Crohn's disease, celiac disease or any other conditions that interfere with absorption.
- •- The subject has had another active malignancy within the past 5 years except for cervical cancer in situ, in situ carcinoma of the bladder or non-melanoma carcinoma of the skin. Questions regarding inclusion of individual subjects should be directed to the Abbott Medical Monitor.
- •- The subject has a medical condition, which in the opinion of the study investigator, places them at an unacceptably high risk for toxicities.
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