EUCTR2013-004698-29-IT进行中（未招募）1 期
A Randomized Phase 2, Double-blind, Placebo-controlled, Multi-center Study Comparing Pemetrexed in Combination with TH-302 vs. Pemetrexed in Combination with Placebo as Second-line Chemotherapy for Advanced Non-Squamous, Non-Small Cell Lung Cancer - TH-CR-415
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 440
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. Men and women = 18 years of age.
- •2. Ability to understand the purposes and risks of the trial and has signed a written informed consent form approved by the investigator’s IRB/EC
- •3. Histologically or cytologically confirmed stage IIIB or IV (AJCC/UICC 7th edition) NSCLC with non-squamous histology (mixed histology allowed if all components are consistent with NSCLC)
- •4. Recurrent or progressive disease after one prior platinum-based non-pemetrexed chemotherapy treatment for advanced disease with or without maintenance
- •a. Neoadjuvant/adjuvant cytotoxic chemotherapy initiated < 12 months prior to study randomization will be counted as one prior treatment
- •b. Neoadjuvant/adjuvant cytotoxic chemotherapy initiated = 12 months prior to study randomization will not be counted as one prior chemotherapy treatment
- •c. Use of targeted agents (e.g., monoclonal antibodies or kinase inhibitors) will not be counted as a prior chemotherapy treatment
- •5. Patients with known EGFR-activating mutations or ALK rearrangements should have received treatment with a targeted kinase inhibitor (e.g., erlotinib, crizotinib) and no longer be considered as a candidate for such treatment
- •6. Measurable disease according to RECIST 1.1
- •7. ECOG performance status 0-1
- •8. Life expectancy of = 3 months
- •9. Resolution to Grade = 1 Adverse Events, of all clinically significant toxic effects of prior therapy (e.g. radiation therapy, maintenance therapy, biopsy procedure; surgery)
- •10. Adequate hematologic, hepatic, and renal function
- •a. Hemoglobin =10 g/dl
- •b. Neutrophils =1,500/mm3 (not requiring G-CSF support)
- •c. Platelets = 100,000/mm3
- •d. Bilirubin <1.5 x ULN (except for patients with Gilbert syndrome)
- •e. AST and/or /ALT = 5 ULN
- •f. Creatinine clearance = 45mL/min (Cockcroft-Gault)
- •11. QTc interval of = 450 msec (males) or 470 msec (females) calculated according to Fridericia’s formula (QTc = QT/RR0.33; RR=RR interval)
- •12. If the patient has reproductive potential, must either be postmenopausal for more than 1 year, surgically sterile, or using effective contraception and agrees to use double barrier or hormonal contraception during the study period and for up to 6 months after the last dose of study medication
- •13. Female patients of childbearing potential must have a negative serum or urine pregnancy test, whichever is considered standard by the institution.
- •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 295
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 145
排除标准
- •1. Diagnosis of small cell carcinoma of the lung, squamous cell carcinoma of the lung or NSCLC NOS (not otherwise specified)
- •2. Prior therapy with pemetrexed
- •3. Inability or unwillingness to take folic acid, vitamin B12 supplementation or corticosteroids
- •4. Inability to discontinue non-steroidal anti-inflammatory drugs for 5 days (long half-life) or for 2 days (short half-life, if CrCL <80 mL/min) before pemetrexed dosing and until 2 days after pemetrexed dosing
- •5. Leptomeningial disease or any untreated or symptomatic brain metastases, unless the following criteria are met:
- •a. Brain metastases are stable and have been previously treated with either whole-brain radiotherapy or gamma-knife surgery
- •b. Steroids are currently not required and more than 14 days since last steroid treatment
- •6. Symptomatic pleural effusion (> CTCAE Grade 1 dyspnea) that is not amenable to drainage
- •7. Treatment with other systemic anticancer therapy within 4 weeks prior to the first dose of study medication
- •8. Treatment with full field radiation therapy within 4 weeks or limited field radiation therapy within 2 weeks prior to the first dose of study medication
- •9. Major surgery within 4 weeks or minor surgery within 2 weeks prior the first dose of study medication
- •10. Elective or a planned major surgery while on study treatment
- •11. Radiation therapy to greater than 25% of the bone marrow
- •12. Clinically significant active infection (e.g. tuberculosis, viral hepatitis, HIV)
- •13. Any other serious uncontrolled medical disorders or psychological conditions that may interfere with study conduct including but not limited to: clinically significant active infection (e.g., tuberculosis, viral hepatitis, HIV), recent (within 6 months) myocardial infarction or unstable angina, unstable arrhythmia, poorly-controlled hypertension or diabetes, or psychiatric condition or history of drug abuse that may interfere with the patient’s ability to follow study procedures
- •14. Concurrent active malignancy other than adequately treated basal cell or squamous cell carcinoma of the skin or pre-invasive carcinoma of the cervix. A patient with previous history of malignancy other than NSCLC is eligible, provided that he/she has been free of disease for = 3 years
- •15. Pregnant or breast feeding
- •16. Patients who are taking medications that prolong QT interval and have a risk of Torsades de Pointes (Appendix F) or who have a history of long QT syndrome
- •17. Patients who are taking medications that are strong inducers or inhibitors of CYP3A4 (Appendix E)
- •18. History of hypersensitivity reaction to any of the study treatment components, including polysorbate 80
研究者
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