EUCTR2008-000977-39-ES进行中（未招募）1 期
A Randomized Phase 2 Study of Ixabepilone Plus Carboplatin and Paclitaxel Plus Carboplatin in Subjects With Advanced Non-Small Cell Lung Cancer / Estudio fase II aleatorizado de ixabepilona mas carboplatino y paclitaxel mas carboplatino en sujetos con cancer de pulmon no microcitico avanzado+ Pharmacogenetics Blood Sample Amendment Number 01 - Site Specific (version 1.0, dated 19-Mar-08) / Enmienda sobre muestras de sangre para farmacogenética - Número 01 - Específica de centro
适应症
相关药物
试验速览
- 阶段
- 1 期
- 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 Stage IV NSCLC, or recurrent disease following surgery and/or radiation therapy;
- •c) Available paraffin embedded tissue to measure the expression levels of ?III 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 6.4.1);
- •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 calculated creatinine clearance (CrCl) based on Cockcroft
- •and Gault < 50 mL/min (see calculation algorithm under Protocol Section 4.2.2)
- •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. Subjects must not initiate any concurrent antineoplastic therapy (ie, chemotherapy, hormonal therapy, immunotherapy, radiation therapy, herbal regimens or standard or investigational agents for 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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