An Open-Label, Randomized, Phase 2 Study of Efficacy and Tolerability of ABT-869 in Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC)

Abbott GmbH & Co. KG0 个研究点目标入组 120 人开始时间: 2008年2月12日最近更新: 2022年4月4日

试验速览

阶段: 1 期
状态: 进行中（未招募）
发起方: Abbott GmbH & Co. KG
入组人数: 120

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

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. Subject must be = 18 years of age.
•2. Subject must be histologically or cytologically diagnosed with locally advanced or
•metastatic NSCLC.
•3. Subjects must have at least one lesion measurable by CT scan as defined by
•RECIST. The measurable lesion may have not received radiation therapy.
•4. Subject has an Eastern Cooperative Oncology Group (ECOG) Performance status
•5. Subject has received at least one prior line of systemic treatment but no more than two treatment regimens for locally advanced or metastatic NSCLC. In addition,
•the subject may have received systemic neo-adjuvant or adjuvant chemotherapy for NSCLC.
•6. Subject must have the following laboratory values:
•? Total Bilirubin = 1.5 × upper normal limit (ULN)
•? AST/ALT = 2.5 × ULN or = 5.0 ULN if subject has liver metastasis
•? PTT = 1.5 × ULN and INR = 1.5
•? ANC = 1.0 × 109/L
•? Platelet count = 75 × 109/L
•? Creatinine = 1.5 × ULN
•7. No other 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.
•8. Women of childbearing potential and men 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. 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
•? 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)
•9. 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. Subject has received anti-cancer therapy within 21 days or 5 half lives, whichever
•is shorter, prior to study drug administration. Anti-cancer therapies include but are
•not limited to: investigational agents, immunotherapy, anti-cancer traditional
•Chinese medicine/herbal remedies, hormonal, targeted agents (i.e., erlotinib,
•imatinib) or biologic therapy. Subject has received cytotoxic chemotherapy (i.e.,
•alkylating agents, microtubule inhibitors, anti-metabolites) within 21 days prior to study drug administration. In addition, subject has not recovered to = Grade 1
•clinically significant adverse effects/toxicities of previous therapy.
•2. Subject has received radiation or undergone major surgery within the previous
•21 days prior to study drug administration.
•3. Subject has received targeted VEGF/PDGF TKI (tyrosine kinase inhibitor) therapy
•(prior Avastin is allowed).
•4. 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 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).
•5. History of greater than 10% weight loss during the 6 weeks prior to study entry.
•6. Subject has significant central thoracic lesions invading or abutting the heart or
•major blood vessels with any appreciable cavitation.
•7. Subject has clinically relevant hemoptysis described as > 5 ml fresh blood within
•the last 3 months. Subjects with only flecks of blood in sputum are permitted.
•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 currently exhibits symptomatic or persistent, uncontrolled hypertension defined as diastolic blood pressure > 100 mmHg or systolic blood
•pressure > 150 mmHg. Subjects may be re-screened if blood pressure is shown to
•be controlled with or without intervention.
•10. The subject has a documented left ventricular ejection fraction < 50%.
•11. Subject is receiving therapeutic anticoagulation therapy. Low dose
•anti-coagulation (e.g., low dose Warfarin) for catheter prophylaxis only will be
•permitted. No low molecular weight heparin is allowed.
•12. Subject is receiving anti-retroviral therapy for HIV.
•13. Female subjects who are pregnant or breast-feeding.
•14. Clinically significant uncontrolled condition(s) including:
•? Active uncontrolled infection
•? Class III or IV heart failure as defined by the New York Heart Association
•functional classification system
•? Unstable angina pectoris or cardiac arrhythmia
•? Myocardial infarction within last 6 months
•? History of adrenal insufficiency
•? History of hemorrhagic cerebral vascular accident within last 6 months
•? Active ulcerative colitis, Crohn's disease, celiac disease or any other
•conditions that interfere with absorption
•? History of autoimmune disease that has kidney involvement
•? History of overt bleeding (> 30 mL bleeding/episode) within 3 months of
•study drug administration
•? Psychiatric illness/social situation that would limit compliance with study
•requirements
•? Any other medical condition, which in the opinion of the study investigator
•places the su

研究者

发起方

Abbott GmbH & Co. KG

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