EUCTR2007-007107-32-CZ进行中（未招募）不适用
A Phase 2 Randomized, Placebo-Controlled, Double-Blind Study of Carboplatin /Paclitaxel in Combination with ABT-869 Versus Carboplatin/Paclitaxel Alone in Subjects with Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) as First-Line Treatment
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 120
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 have cytologically or histologically confirmed non-squamous NSCLC. Subjects may have a mixed histology but must be predominantly non- squamous to be eligible.
- •3. The subject must have recurrent or advanced (Stage IIIb with pleural or pericardial
- •effusion) or metastatic (Stage IV) disease that is not amenable to surgical resection
- •or radiation with curative intent.
- •4. The subject has measurable disease, defined as at least 1 unidimensionally
- •measurable lesion on a computed tomography (CT) scan as defined by RECIST
- •(for subjects in the randomized portion only).
- •5. The subject has an ECOG Performance Score of 0-1.
- •6. 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.
- •7. 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;
- •? 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).
- •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
- •8. 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 hypersensitivity to paclitaxel or to other drugs formulated with
- •polyethoxylated castor oil (Cremophor).
- •2. The subject has received any anti-cancer therapy for treatment of NSCLC
- •including investigational agents, immunotherapy, traditional Chinese
- •medicine/herbal remedies, hormonal, targeted agents (i.e., erlotinib, imatinib),
- •biologic therapy or cytotoxic chemotherapy (i.e., alkalating agents, microtubule
- •inhibitors, antimetabolites).
- •3. Subject has received radiation therapy within 21 days of Study Day 1.
- •4. The subject has had major surgery within 21 days.
- •5. The subject has 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(s) 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).
- •6. The subject is receiving therapeutic anticoagulation therapy. Low dose
- •anticoagulation (e.g., low dose Warfarin®) for catheter prophylaxis will be
- •7. The subject has a central thoracic tumor lesion as defined by location within the
- •hilar structures. The presence of central nodal disease is allowed.
- •8. 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.
- •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) > 90 mm Hg or systolic BP > 140 mm Hg. Subjects may be re-screened if BP 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 (i.e., lupus).
- •14. The subject is receiving combination anti-retroviral therapy for HIV.
- •15. 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; or
- •? Psychiatric illness/social situation that would limit compliance with study
- •requirements.
- •16. The subject has a history of another active cancer within the past 5 years except
- •cervical cancer in situ, in situ carcinoma of the bladder, squamous cell or basal cell
- •carcinoma of the skin. Questions regarding inclusion of individual subjects should
- •be directed to the Abbott Medical Monitor.
- •17. The subject has active ulcerative colitis, Crohn's disease, celiac disease or any
- •other conditions that interfere with absorption.
- •18. The subject has a medical conditi
研究者
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