EUCTR2009-016083-36-DE进行中（未招募）不适用
Phase 2 Study of CS-7017 and Erlotinib in Subjects with Advanced Non-Small Cell Lung Cancer Who Failed First Line Therapy
Daiichi Sankyo Pharma Development0 个研究点目标入组 90 人开始时间: 2010年10月18日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 90
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
- •Subjects must satisfy all of the following criteria to be included in the study:
- •1. Histologically or cytologically confirmed stage IIIB or IV NSCLC previously treated with a platinum-based regimen.
- •2. Progressive disease (either no response to treatment or subsequent relapse after an objective response) after the last anti-cancer therapy.
- •3. Measurable disease according to Response Evaluation Criteria In Solid Tumors (RECIST) Version 1.1 criteria.
- •4. = 18 years of age
- •5. ECOG performance status of 0, 1, or 2.
- •6. Adequate organ and bone marrow function as assessed by clinical laboratory evaluations:
- •- Hemoglobin = 9 g/L
- •- Absolute neutrophil count = 1.5 x 10e9/L
- •- Platelets = 100 x 10e9 /L
- •- Serum creatinine <1.5 upper limit of normal (ULN) or calculated
- •creatinine clearance > 60 mL/min
- •- Aspartate aminotransferase (AST), alanine aminotransferase (ALT), and alkaline phosphatase < 2.5 x ULN if liver metastases are absent or = 5.0 x ULN if liver metastases are present
- •- Total bilirubin =1.5 x ULN
- •7. Resolution of any toxic effects of prior therapy (except alopecia) to NCI CTCAE, Version 4.0, grade = 1 (see Section 17.2).
- •8. Women of childbearing potential must be willing to consent to using effective contraception (eg, hormonal contraceptives, bilateral tubal ligation, barrier with spermicide, intrauterine device) while on treatment and for at least 3 months thereafter. Men who are the partner of a woman of childbearing potential must be willing to consent to using effective contraception (eg, vasectomy or barrier with spermicide) while on treatment and for 3 months thereafter.
- •9. All female subjects of childbearing potential must have a negative serum or urine pregnancy test result before initiating study treatment.
- •10. Subjects must be fully informed about their illness and the investigational nature of the study protocol (including foreseeable risks and possible side effects) and must sign and date an IEC- or IRB-approved ICF (including HIPAA authorization, if applicable) before performance of any study-specific procedures or tests.
- •11. Subjects must be willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study 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
- •Subjects who meet any of the following criteria will be disqualified from entering the study:
- •1. More than two prior chemotherapy regimens for advanced disease. Maintenance
- •therapy does not count as a separate regimen, if it is given after first line therapy
- •without intervening disease progression.
- •2. Prior treatment with EGFR inhibitors.
- •3. Treatment with anticancer therapy within 3 weeks before study treatment.
- •4. Therapeutic or palliative radiation therapy within 2 weeks or major surgery within
- •4 weeks before study treatment.
- •5. Prior administration of other TZDs within 4 weeks before study treatment or current need for concomitant use of other TZDs during the study.
- •6. Clinically active brain metastases, defined as untreated symptomatic, or requiring therapy with steroids or anticonvulsants to control associated symptoms; uncontrolled seizure disorder; spinal cord compression; or carcinomatous meningitis. Subjects with treated brain metastases which are no longer symptomatic and require no treatment may be included in the study if they have recovered from the acute toxic effect of radiotherapy. A minimum of 15 days must have elapsed between the end of radiotherapy and study enrollment.
- •7. Uncontrolled infection requiring IV antibiotics, antivirals, or antifungals, known human immunodeficiency virus (HIV) infection, or active hepatitis B or C infection at time of screening.
- •8. History of any of the following conditions within 6 months before initiating study treatment: diabetes mellitus requiring treatment with insulin or TZD agents; myocardial infarction with significant impairment of cardiac function; severe/unstable angina pectoris; coronary/peripheral artery bypass graft; New York Heart Association (NYHA) class III or IV congestive heart failure; malabsorption syndrome, chronic diarrhea (lasting > 4 weeks), inflammatory bowel disease, or partial bowel obstruction.
- •9. Pericardial effusion or pericardial involvement with the tumor. Clinically significant pleural effusion (ie, requiring drainage). Subjects with minimal pleural effusion may be eligible upon request by Investigator and approval by Sponsor.
- •10. History of malignancy other than NCSLC, except adequately treated
- •non melanoma skin cancer, curatively treated in-situ cancer of the cervix or other
- •solid tumors curatively treated with no evidence of disease for = 5 years.
- •11. Previous administration of CS-7017.
- •12. Pregnant or breast feeding.
- •13. Serious intercurrent medical or psychiatric illnesses or any other conditions that in
- •the opinion of the Investigator would impair the ability to give informed consent
- •or unacceptably reduce protocol compliance or safety of the study treatment.
- •14. Known hypersensitivity to any of the two study drugs.
- •15. Subjects currently enrolled in another investigational drug study or within
- •4 weeks of start of treatment.
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