Extended Use of ModraDoc006/r
Safety of Extended Use of ModraDoc006/r in Patients With Advanced Solid Tumours
研究概览
详细说明
This is an open label extended use programme, designed to make extended use treatment with weekly ModraDoc006/r available for patients who completed treatment in one of the phase I trials with ModraDoc006/r, who might have clinical benefit of continued treatment with the oral docetaxel formulation.
Patients will receive oral docetaxel (as ModraDoc006 10 mg tablets) and ritonavir (100 mg tablet) once- or bi-daily, once a week in a fasted condition. Treatment can be continued weekly as long as the patient experiences clinical benefit from the treatment as judged by the treating oncologist, unless unacceptable toxicity despite dose modifications and supportive measures occurs.
研究类型
注册 (实际的)
阶段
- 阶段1
联系人和位置
学习地点
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Amsterdam、荷兰、1066 CX
- Netherlands Cancer Institute - Antoni van Leeuwenhoek
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Histological or cytological proof of cancer
- Patients who might benefit from a weekly (oral) docetaxel regime as judged by the treating oncologist.
- 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.
- Age ≥ 18 years
- WHO performance status of 0, 1 or 2;
Minimal acceptable laboratory values defined as:
- ANC of ≥ 1.5 x 109 /L
- Platelet count of ≥ 100 x 109 /L
- Renal function as defined by serum creatinine ≤ 1.5 x ULN or creatinine clearance ≥ 50 ml/min (by Cockcroft-Gault formula)
- Hepatic function as defined by serum bilirubin ≤ 2 x ULN, ALAT and ASAT ≤ 5.0 x ULN, except for patients who have been treated in the N16DOL study.
- 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.
- Able and willing to swallow oral medication
Exclusion Criteria:
- 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.
- 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.
- 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.
- 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).
- 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.
- 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.
- Bowel obstructions or motility disorders that may influence the resorption of drugs as judged by the treating physician.
- Patients with known alcoholism, drug addiction and/or psychiatric of physiological 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.
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:不适用
- 介入模型:单组作业
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的:ModraDoc006/r
每周 ModraDoc006/r 治疗为 ModraDoc006(口服多西紫杉醇)10 毫克片剂联合利托那韦 100 毫克片剂
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每周一次 ModraDoc006(口服多西紫杉醇)10 毫克片剂与利托那韦 100 毫克片剂联合治疗
其他名称:
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
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The hematological and non-hematological toxicity profile of oral docetaxel in combination with ritonavir
大体时间:Safety and tolerance will be evaluated during the complete study treatment until 28 days after the last intake, using the CTCAE v.4.03 grading system
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The number of CTCAE v.4.03 grade 3-4 toxicities during treatment with ModraDoc006/r
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Safety and tolerance will be evaluated during the complete study treatment until 28 days after the last intake, using the CTCAE v.4.03 grading system
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合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.
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ModraDoc006/r的临床试验
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Modra PharmaceuticalsThe Netherlands Cancer Institute完全的
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Modra Pharmaceuticals完全的
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