NL-OMON38495撤回不适用
Absorption and excretion of docetaxel (as ModraDoc 005 tablets) after oral administration in combination with ritonavir. - N13AED
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
- 撤回
- 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
- Interventional
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 * 18 years;
- •5. Able and willing to give written informed consent;
- •6. WHO performance status of 0, 1 or 2;
- •7. Able and willing to undergo blood sampling , urine and faeces sampling for PK;
- •8. Able and willing to comply with the study protocol for the duration of the study;
- •9. Life expectancy * 3 months allowing adequate follow up of toxicity evaluation and antitumor activity;
- •10. Evaluable disease according to RECIST 1.1 criteria;
- •11. Minimal acceptable safety laboratory values:
- •a. ANC of * 1.5 x 109 /L
- •b. Platelet count of * 100 x 109 /L
- •c. Hepatic function as defined by serum bilirubin * 1.5 x ULN, ALAT and ASAT * 2.5 x ULN (or * 5 x ULN in case of liver metastases)
- •d. Renal function as defined by serum creatinine * 1.5 x ULN or creatinine clearance * 50 ml/min (by Cockcroft-Gault formula).
- •12. Negative pregnancy test (urine/serum) for female patients with childbearing potential;
- •13. No radio- or chemotherapy within the last 4 weeks prior to study entry (palliative limited radiation for pain control is allowed)
- •14. Able and willing to swallow oral medication
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, including but not limited to Ca¬¬+-entry blockers (verapamil, dihydropyridines), cyclosporine, quinidine, quinine, tamoxifen, megestrol and grapefruit juice, concomitant use of HIV medications; other protease inhibitors, (non) nucleoside analogs, 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, excluding alopecia
- •7. Bowel obstructions or motility disorders that may influence the absorption of drugs
- •8. Neurologic disease that may render a patient at increased risk for peripheral or central neurotoxicity
- •9. Pre-existing neuropathy greater than CTC grade 1
- •10. Symptomatic cerebral or leptomeningeal metastases
- •11. 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.
- •12. Legal incapacity
研究者
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