A phase I study of the combination of daily oral SU11248 (Sunitinib) with intravenous ifosfamide in patients with advanced solid malignancies. - SU11248/Ifosfamide

Erasmus MC, Universitair Medisch Centrum Rotterdam0 个研究点目标入组 72 人开始时间: 待定最近更新: 2024年6月18日

试验速览

暂无简介。

•- Histologically or cytologically proven advanced solid malignancy in patients for whom no better treatment than SU11248 and ifosfamide is available.
•- Measurable (according to RECIST criteria) or evaluable disease.
•- At least 4 weeks since any prior anti-tumor therapy and resolution of all toxicities induced by this prior anti-tumor treatment to CTC grade <= 1 (if not specified below) except alopecia.
•- Age >= 18 years.
•- WHO performance of 0-1 and a predicted life expectancy of at least 3 months.
•- Adequate organ function defined as follows:
•serum bilirubin <= 1.5 x ULN
•serum AST and ALT <= 2.5 x ULN (in case of liver metastases, then AST/ALT must be <= 5 x ULN)
•serum creatinine <= 1.5 x ULN creatinine clearance >= 60 ml/min and 2 functioning kidneys
•ANC >= 1.5 x 109/L
•platelets >= 100 x 109/L
•hemoglobin >= 6.0 mmol/L
•- Systolic blood pressure lower than 150 mmHg and diastolic blood pressure lower than 90 mmHg (treatment with 2 antihypertensive drugs is allowed)

•- severe/unstable angina or symptomatic congestive heart failure within 12 months prior to inclusion
•- myocardial infarction, or cerebrovascular accident within 12 months prior to inclusion
•- atrial fibrillation of any grade or ongoing cardiac dysrhythmias >= grade 2
•- known human immunodeficiency virus (HIV) positivity
•- use of prohibited co-medication as mentioned in paragraph 5.4
•- pregnancy and / or breast feeding; for all women of child-bearing potential a negative pregnancy test will be required as well as the willingness to use adequate contraception during the study until 4 weeks after stopping treatment.
•- signs or symptoms of CNS metastases (radiological assessment of potential CNS metastases is not required).
•- any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be assessed with the patient before registration in the trial.
•- other severe medical or psychiatric conditions that in the judgment of the investigator renders the patient inappropriate for inclusion in this study.

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