NL-OMON35601已完成不适用
Mass balance of docetaxel after administration of Oral Docetaxel in combination with Ritonavir - N11ODR
Antoni van Leeuwenhoek Ziekenhuis0 个研究点目标入组 6 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
- 已完成
- 发起方
- 入组人数
- 6
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1. Histological or cytological proof of cancer
- •2. Patient for whom no standard therapy of proven benefit exist
- •3. Patients who might benefit from treatment with docetaxel, e.g. advanced breast, gastric, esophagus, bladder, ovarian cancer and non-small cell lung cancer, head and neck cancer, prostate cancer and carcinoma of unknown primary site.
- •4. Age GE 18 years
- •5. Able and willing to give written informed consent
- •6. Able and willing to undergo blood sampling for pharmacokinetics
- •7. Able and willing to comply with the study protocol for the duration of the study
- •8. Life expectancy GE 3 months allowing adequate follow up of toxicity evaluation and antitumor activity
- •9. Minimal acceptable safety laboratory values
- •a. ANC of GE 1.5 x 10^9 /L
- •b. Platelet count of GE 100 x 10^9 /L
- •c. Hepatic function as defined by serum bilirubin LE 1.5 x ULN, ALAT and ASAT LE 2.5 x ULN
- •d. Renal function as defined by serum creatinine LE 1.5 x ULN or creatinine clearance GE 50 ml/min (by Cockcroft-Gault formula).
- •10. WHO performance status of 0, 1 or 2
- •11. No radio- or chemotherapy within the last 4 weeks prior to study entry (except for palliative single dose radiotherapy for pain reduction)
- •12. Able and willing to swallow oral medication;GE = Greater or Equal than
- •LE = Less or Equal than
排除标准
- •1. Patients with known alcoholism, drug addiction and/or psychotic disorders in the history that are not suitable for adequate follow up
- •2. Women who are pregnant or breast feeding.
- •3. Unreliable contraceptive methods. Both men and women enrolled in this trial must 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).
- •4. Concomitant use of MDR and CYP3A modulating drugs such as Ca+ -entry blockers (verapamil, dihydropyridines), cyclosporine, quinidine, quinine, tamoxifen, megestrol and grapefruit juice, concomitant use of HIV medications; other protease inhibitors, (non) nucleoside analoga, St. Johns wort or macrolide antibiotics as erythromycin and clarithromycin.
- •5. Uncontrolled infectious disease or known HIV-1 or HIV-2 type patients
- •6. Unresolved (>grade 1) toxicities of previous chemotherapy
- •7. Bowel obstructions or motility disorders that may influence the absorption of drugs
- •8. Chronic use of H2-receptor antagonists or proton pump inhibitors
- •9. Neurologic disease that may render a patient at increased risk for peripheral or central neurotoxicity
- •10. Pre-existing neuropathy greater than CTC grade 1
- •11. Symptomatic cerebral or leptomeningeal metastases
- •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.
- •13. Legal incapacity
研究者
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