EUCTR2006-002838-38-GB进行中（未招募）不适用
A Phase 2 Study Evaluating the Safety and Efficacy of ABT-751 in Combination with Docetaxel Versus Docetaxel Alone in Subjects with Advanced or Metastatic Non-Small Cell Lung Cancer - Phase 2 Study evaluating safety and efficacy of ABT-751 and Docetaxel in NSCLC
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 180
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 is = 18 years old.
- •2.The subject has pathologically (histologically or cytologically) documented NSCLC.
- •3.The subject has locally advanced (Stage III) NSCLC not amenable to curative surgery or radiotherapy or metastatic (Stage IV) NSCLC.
- •4.The subject has received only one prior anti-tumor treatment regimen in the advanced (Stage III non-curable or metastatic Stage IV) setting (i.e., study participation must be second-line therapy in the metastatic setting).
- •5.The subject may have received one additional anti-tumor treatment regimen in the neo-adjuvant or adjuvant setting.
- •6.The subject has experienced progressive disease either during or following the previous anti-tumor treatment regimen.
- •7.The subject has the presence of measurable disease by RECIST criteria.
- •8.Subjects with brain metastases must have had clinically controlled neurologic symptoms, defined as surgical excision and/or radiation therapy followed by 30 days of stable neurologic function and no evidence of CNS disease progression.
- •(Subjects with symptoms of CNS metastasis at Screening must have computed tomography [CT] or magnetic resonance imaging [MRI] scans of the brain prior to study entry that demonstrate no evidence of disease.)
- •9.The subject has an Eastern Cooperative Oncology Group (ECOG) performance score of = 2.
- •10.All anti-tumor therapy must be discontinued at least 3 weeks prior to ABT 751/placebo and docetaxel administration.
- •11.All adverse events from prior anti-tumor treatment are resolved or stable.
- •12.The subject's life expectancy is = 3 months.
- •13.The subject must have adequate hematologic, renal and hepatic function as follows:
- •Hematology:
- •Absolute Neutrophil Count (ANC): =2000/mm3
- •Platelet Count: =100,000/mm3
- •Hemoglobin: = 9.0 g/dL
- •Renal Function:
- •Creatinine:Creatinine Clearance =45 mL/min*
- •Hepatic Function:
- •Bilirubin:=1.5 mg/dL (=3.0 mg/dL with liver metastasis)**
- •Serum Glutamic-Oxaloacetic Transaminase (SGOT): = 2.5 x ULN (= 5.0 x ULN with liver metastasis)
- •Serum Glutamic-Pyruvic Transaminase (SGPT): = 2.5 x ULN (= 5.0 x ULN with liver metastasis)
- •*If calculated creatinine clearance is < 45 mL/min, a 24-hour urine collection for creatinine clearance may be performed.
- •**Subjects with Gilbert's disease may have bilirubin up to 2.5 mg/dL (or 3.0 mg/dL with liver metastasis).
- •14.Female subjects must be surgically sterile, postmenopausal (for at least 1 year), or have negative results for a serum pregnancy test.
- •15.All female subjects not surgically sterile or postmenopausal (for at least 1 year) and non-vasectomized male subjects must practice at least one of the following methods of birth control:
- •?Total abstinence from sexual intercourse during the study (minimum one complete menstrual cycle prior to study start);
- •?Vasectomized partner;
- •?Hormonal contraceptives (oral, parenteral, or transdermal) for at least 3 months prior to and during study drug administration;
- •?Double-barrier method (condoms, contraceptive sponge, or vaginal ring with spermicidal jellies or creams).
- •16.The subject is amenable to completing the Quality of Life (QoL) questionnaire.
- •17.The subject has voluntarily signed and dated an informed consent form, approved by an Independent Ethics Committee (IEC)/Institutional Review Board (IRB), prior to any non-routine 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
排除标准
- •1.The subject has NCI CTCAE (version 3.0) neurology category findings (e.g., paresthesia, impaired deep tendon reflexes, or weakness) greater than Grade 1.
- •2.The subject has a documented allergy to sulfa medications.
- •3.The subject has glucose-6-phosphate dehydrogenase deficiency.
- •4.The subject has porphyria.
- •5.The subject has previously received ABT-751 or docetaxel.
- •6.The subject has received more than one investigational agent for NSCLC as a single agent or part of a previous regimen. (An investigational agent is any drug not currently approved for use in humans. Please contact the Abbott medical monitor with questions regarding investigational agents.)
- •7.The subject exhibits significant weight loss (= 10%) during the 6 weeks before study entry.
- •8.The subject has a significant history of cardiac, renal, neurologic, psychiatric, endocrinologic, metabolic, or hepatic disease that would adversely affect his/her participating in this study. Questions regarding inclusion of individual subjects should be directed to the Abbott medical monitor.
- •9.The subject has a current history of a Class 3-4 cardiovascular disability status in accordance with the New York Heart Association Functional Classification.
- •?Class 3 is defined as marked limitation of physical activity, comfortable at rest, but less than ordinary activity causes fatigue or dyspnea.
- •?Class 4 is defined as being unable to carry on any physical activity without symptoms and symptoms are present even at rest. Also, if any physical activity is undertaken, symptoms are increased.
- •10.A female subject who is pregnant or breastfeeding.
- •11.The subject has previous or current malignancies at other sites, with the exception of:
- •?adequately treated in situ carcinoma of the cervix uteri;
- •?basal or squamous cell carcinoma of the skin;
- •?previous nonpulmonary malignancy (e.g., localized prostate cancer) confined and surgically resected, treated with chemotherapy or radiation therapy, and is considered cured by the investigator.
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