NL-OMON31053尚未招募不适用
Phase I study of gemcitabine and carboplatin plus sorafenib in patients with advanced solid tumors - Phase I study Gemcitabine and carboplatin plus sorafenib
Antoni van Leeuwenhoek Ziekenhuis0 个研究点目标入组 28 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
- 尚未招募
- 发起方
- 入组人数
- 28
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
- •Patients with progressive advanced solid tumor who are considered for palliative gemcitabine plus carboplatinb combination chemotherapy.
- •Furthermore:
- •> 18 years.
- •Performance: WHO 0 - 2.
- •Life expectancy > 3 months.
- •Histological or cytological proof of malignancy.
- •Measurable disease according to RECIST criteria.
- •Minimal acceptable safety laboratory values.
- •o ANC of >= 1.5 × 109/L
- •o Platelet count of >= 100 × 109/L
- •o Haemoglobin level of >= 10 g/dL (>= 6.2 mmol/L)
- •(prior transfusion is permitted)
- •o Hepatic function as defined by serum bilirubin <= 1.25 times the upper limit of normal (ULN), ALT and AST <= 2.5 times the ULN, except if liver metastases then ALAT and ASAT < 5 times the ULN.
- •o Renal function as defined by serum creatinine <= 1.25 times ULN or creatinine clearance >= 50 ml/min (by Cockcroft-Gault formula).
- •Able to swallow and retain oral medication.
- •Written informed consent.
- •Willingness to use a medically approved method of contraception
- •Caution is recommended when administering sorafenib with inhibitors of the CYP3A4 family (eg, ketoconazole, itraconazole, erythromycin, clarithromycin, warfarine).
排除标准
- •Previous investigational cytotoxic or biological treatment for malignant disease within 30 days before the start of the study.
- •Any treatment with non-oncological investigational drugs within 30 days before the start of the study.
- •Radiotherapy within 2 weeks prior to study entry.
- •Major surgery within 4 weeks prior to study treatment.
- •Patients using medications or substances known to affect, or with the potential to affect the activity or pharmacokinetics of sorafenib.
- •Pregnancy or breast feeding (all women of childbearing potential must have a pregnancy test before inclusion in the study; post-menopausal women must have amenorrhoea for at least 12 months). All patients must use adequate contraceptive protection.
- •History of alcoholism, drug addiction, or any psychiatric or psychological condition, which in the opinion of the investigator would impair study compliance.
- •Concurrent or previous malignancy of a different tumour type within five years of starting the study except for adequately treated non-melanoma skin cancer or cervical intraepithelial neoplasia
- •Legal incapacity
- •Uncontrolled or poorly controlled hypertension (Systolic blood pressure >= 150 mmHg, diastolic blood pressure >= 90 mmHg). Initiation or adjustment of blood pressure medications is permitted prior to study treatment provided that 3 consecutive BP readings are less than 150/90 mmHg, each separated by at least 24 hours
- •History of malabsorption syndrome or other disease that could significantly affect absorption of drugs
- •Systemic steroids within 2 weeks prior to study treatment
- •Myocardial infarction or cerebrovascular accident (CVA) within 6 months prior to study treatment
- •Congestive heart failure requiring medication.
- •Symptomatic brain metastases.
- •Hepatic dysfunction
- •Uncontrolled infections.
- •Known human immunodeficiency virus (HIV) infection
- •Known chronic or acute viral hepatitis
- •Patients who have known hypersensitivity to the study medication
研究者
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