NL-OMON45294招募中2 期
Safety of extended use of ModraDoc006/r in patients with advanced solid tumours - ModraDoc006/r in extended use
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 200
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 64（—）
入选标准
- •1. Histological or cytological proof of cancer
- •2. Patients who might benefit from a weekly (oral) docetaxel regime as judged by the treating oncologist.
- •3. Patients who received treatment with ModraDoc006/r with acceptable safety (as judged by the PI; for criteria see below in section 3 of exclusion criteria) in phase I trials with ModraDoc006/r, including (but not limited to) the N15FED (food-interaction study), N16AED (absorption-excretion study), N16DOL (normal or impaired liver function). A maximum delay of 21 days between the last dose in the previous phase I trial and the first dose in the N17DEX is allowed.
- •4. Age >= 18 years
- •5. WHO performance status of 0, 1 or 2;
- •6. Minimal acceptable laboratory values defined as:
- •a. ANC of >= 1.5 x 109 /L
- •b. Platelet count of >= 100 x 109 /L
- •c. Renal function as defined by serum creatinine equal or lower than 1.5 x ULN or creatinine clearance equal or higher than 50 ml/min (by Cockcroft-Gault formula)
- •d. Hepatic function as defined by serum bilirubin equal or lower than 1.5 x ULN, ALAT and ASAT equal or lower than 5.0 x ULN, except for patients who have been treated in the N16DOL study.
- •7. Negative pregnancy test (urine/serum) for female patients with childbearing potential, assessed at the screening visit of the previous phase I trial with ModraDoc006/r.
- •8. Able and willing to swallow oral medication
排除标准
- •1. 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 analogs, St. John*s wort or macrolide antibiotics.
- •2. Symptomatic brain metastases or leptomeningeal metastases. Patients with brain metastases are allowed if they received adequate treatment, are asymptomatic in the absence of corticosteroid therapy and anticonvulsant therapy for at least 6 weeks. Radiotherapy for brain metastases must have been completed at least 4 weeks prior to start of study treatment.
- •3. Clinically significant safety issues during previous therapy with ModraDoc006/r as judged by the PI, which cannot be solved by dose reduction and/or treatment delay.
- •4. Unreliable contraceptive methods. Both men and women using ModraDoc006/r 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).
- •5. Anti-cancer therapy or any treatment with investigational drugs other than ModraDoc006/r between the completion of the phase I trial with ModraDoc006/r and the start of extended use of ModraDoc006/r Palliative radiation on limited field is allowed.
- •6. Uncontrolled infectious disease or known Human Immunodeficiency Virus HIV-1 or HIV-2 type patients. Patients with a known history of hepatitis B or C.
- •7. Bowel obstructions or motility disorders that may influence the resorption of drugs as judged by the treating physician.
- •8. Patients with known alcoholism, drug addiction and/or psychiatric of psychological condition which in the opinion of the investigator would impair study compliance; 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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