EUCTR2008-000977-39-DE进行中（未招募）不适用
A Randomized Phase 2 Study of Ixabepilone Plus Carboplatin and Paclitaxel Plus Carboplatin in Subjects With Advanced Non-Small Cell Lung CancerRevised Protocol 02 incorporating Amendment 03 (version 4.0 dated 01-Sep-09)+ Pharmacogenetics Blood Sample Amendment Number 01 - Site Specific (version 1.0, dated 19-Mar-08)
适应症
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
- 320
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) Signed Written Informed Consent
- •2) Target Population
- •a) Histologically confirmed NSCLC (squamous cell, adenocarcinoma, large cell or bronchoalveolar carcinoma);
- •b) Stage IIIB with pleural effusion (or otherwise not suitable for loco-regional
- •therapy with curative intent), or Stage IV NSCLC, or recurrent disease following
- •surgery and/or radiation therapy;
- •c) Available paraffin embedded tissue to measure the expression levels of ßIII tubulin (also see Protocol Section 5.2);
- •d) Measurable disease by RECIST guidelines, with at least 1 target lesion outside any previous radiotherapy field (also see Protocol Section 7.2.1.1);
- •e) Karnofsky performance status (KPS) of 70 - 100 (see Protocol Appendix 3);
- •f) Life expectancy of at least 3 months;
- •g) Accessible for treatment and follow-up. Subjects enrolled in this trial must be treated at the participating center(s).
- •3) Age and Sex
- •a) Men and women, age = 18 years.
- •Women of childbearing potential (WOCBP) must be using an adequate method of contraception to avoid pregnancy throughout the study and for up to 4 weeks after end of investigational products in such a manner that the risk of pregnancy is minimized. In general, the decision for appropriate methods to prevent pregnancy should be determined by discussions between the Investigator and the study subject.
- •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) Sex and Reproductive Status
- •a) WOCBP who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study periodand for up to 4 weeks after the last dose of investigational product;
- •b) Women who are pregnant or breastfeeding;
- •c) Women with a positive pregnancy test on enrollment or prior to investigational product administration;
- •d) Sexually active fertile men not using effective birth control if their partners are WOCBP.
- •2) Target Disease Exceptions
- •a) Uncontrolled brain metastases (active brain metastases including evidence of cerebral edema by CT scan or MRI, or progression from prior imaging study, any requirement for steroids, or clinical symptoms of/from brain metastases. Subjects with known metastases must have a baseline imaging scan within 4 weeks of randomization).
- •3) Medical History and Concurrent Diseases
- •a) Peripheral neuropathy > Grade 1;
- •b) Less than 4 weeks from prior radiation therapy or loco-regional surgeries to randomization date (less than 1 week from focal/palliative RT, or minor surgery);
- •c) Dementia, altered mental status, or any psychiatric condition that would prohibit the understanding or rendering of informed consent or completing questionnaires;
- •d) A serious uncontrolled medical disorder that, in the opinion of the investigator, would impair the ability of the subject to receive protocol therapy;
- •e) Any concurrent malignancy other than non-melanoma skin cancer, or carcinoma in situ of the cervix;
- •f) Known HIV positive.
- •4) Physical and Laboratory Test Findings
- •a) Hematologic function (all baseline laboratory information must be obtained within 14 days prior to randomization):
- •i) Absolute neutrophil count (ANC) < 1500 cells/mm³;
- •ii) Hemoglobin < 9.0 g/dL;
- •iii) Platelets < 100,000 cells/mm³
- •b) Hepatic function:
- •i) Total bilirubin greater than Upper Limit of Normal (ULN) as defined by the institution (with the exception of elevation due to Gilbert’s syndrome);
- •ii) Aspartate transaminase (AST) or alanine transaminase (ALT) > 2.5 x ULN.
- •c) Serum creatinine = 1.5 mg/dL;
- •d) Renal function with a creatinine clearance (CrCl) < 50 mL/min (measured or calculated by Cockcroft-Gault method).
- •5) Allergies and Adverse Drug Reactions
- •a) Known prior severe hypersensitivity reactions to agents containing Cremophor®EL.
- •6) Prohibited Treatments and/or Therapies
- •a) Any prior antineoplastic systemic regimens for the treatment of NSCLC;
- •b) Subjects must not continue treatment with strong inhibitors or inducers of CYP3A4 (see Protocol Section 5.5.1 for further details).
- •7) Other Exclusion Criteria
- •a) Prisoners or subjects who are involuntarily incarcerated;
- •b) Subjects who are compulsorily detained for treatment of either a psychiatric or physical (eg, infectious disease) illness.
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