NL-OMON42448撤回不适用
A phase I dose-finding study of bi-daily weekly ModraDoc006/ritonavir as switch maintenance therapy after platinum doublet therapy in patients with non-small cell lung cancer. - Maintenance treatment with ModraDoc/ritonavir in patients with NSCLC
Antoni van Leeuwenhoek Ziekenhuis0 个研究点目标入组 15 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 入组人数
- 15
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1.Histological or cytological proof of stage IV NSCLC.
- •2.Patients who did not experience disease progression after four cycles of first line standard platinum doublet chemotherapy (not including a taxane).
- •3.Registered and start within six weeks after the last platinum-combination therapy administration.
- •4.Age of 18 years or older.
- •5.Able and willing to give written informed consent.
- •6.Minimal acceptable safety laboratory values.;a. Hb *6.0 mmol/L;b. ANC of * 1.5 x 109 /L ;c. Platelet count of * 100 x 109 /L;d. Hepatic function as defined by serum bilirubin * 1.5 x ULN, ALAT and ASAT * 2.5 x ULN (5 X ULN if liver metastases are present). ;e. Renal function as defined by serum creatinine * 1.5 x ULN or creatinine clearance * 50 ml/min (by Cockcroft-Gault formula).;7. WHO performance status of 0 or 1.;8. Able and willing to swallow oral medication.
排除标准
- •1.Prior adjuvant or neo-adjuvant chemotherapy for NSCLC.
- •2.Previous treatment with a taxane.
- •3.Patients with suspected or known brain metastases.
- •4.Patients with known alcoholism, drug addiction, psychotic disorders in their history and/or other reasons, for which they are not amenable for adequate follow up.
- •5.Women who are pregnant or breast-feeding.
- •6.Both men and women enrolled in this trial who do not agree to use a reliable contraceptive method throughout the study (adequate contraceptive methods are: condom, sterilization, other barrier contraceptive measures preferably in combination with condoms).
- •7.Concomitant use of MDR and CYP3A modulating drugs and agents such as Ca¬¬+-entry blockers (verapamil, dihydropyridines), cyclosporine, (non) nucleoside analogs, St. Johns worth, macrolide antibiotics as erythromycin and clarithromycin, quinidine, quinine, tamoxifen, megestrol, concomitant use of HIV medication or other protease inhibitors, grapefruit juice (see for an extended list appendix VI).;8. Chronic use of corticosteroids corresponding to a dose of >10 mg prednisone. ;9. Unresolved (> grade 1) toxicities of previous chemotherapy, excluding alopecia.;10. Bowel obstructions or motility disorders that may influence the absorption of the study drug.;11. Pre-existing neuropathy greater than NCI-CTCAE v4.03 grade 1.;12. Evidence of any other disease, neurological or metabolic dysfunction, physical examination finding or laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or puts the patient at high risk for treatment-related complications.
研究者
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