EUCTR2006-004824-35-DE进行中（未招募）不适用
A double-blind, randomized phase II study of once daily versus twice daily PTK787/ZK 222584 treatment in patients with advanced, previously treated metastatic adenocarcinoma of the colon or rectum - Comparison of once daily versus twice daily administration of PTK787/ZK 222584 in mCRC
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Schering AG
- 入组人数
- 70
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Signed written informed consent obtained in accordance to local and institutional
- •2. Male or female patients aged = 18 years
- •3. Histologically confirmed metastatic adenocarcinoma of the colon or rectum
- •4. At least one line of prior standard chemotherapy for metastatic disease;
- •standard systemic therapy for metastatic disease includes fluoropyrimidines,
- •oxaliplatin and irinotecan
- •5. Measurable lesion(s) as per the modRECIST criteria (see Attachment 1)
- •6. At least 1 measurable liver lesion with the size of at least 3 cm for DCE-MRI
- •evaluation (see Attachment 2)
- •7. WHO Performance status 0 to 2
- •8. Laboratory values obtained within the last 2 weeks before randomization:
- •Absolute neutrophil count (ANC) = 1.5 x 109/L
- •Platelets = 100 x 109/L
- •Hemoglobin = 9 g/dL
- •Serum creatinine = 1.5 times ULN
- •Serum bilirubin = 1.5 times ULN
- •Aspartate aminotransaminase (AST/SGOT) and alanine aminotransaminase
- •(ALT/SGPT) = 3.0 times ULN (= 5times ULN, if liver metastases)
- •Urine negative for proteinuria based on dip stick reading
- •or, if dip stick result is = '+1', then 24 hour urine collection with total urinary
- •protein value = 500 mg and measured creatinine clearance = 50 mL/min
- •9. Life expectancy = 12 weeks
- •10. Negative pregnancy test not longer than 48 hours before administration of the
- •study treatment for females of childbearing potential
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Full-field radiotherapy = 4 weeks or limited field radiotherapy = 2 weeks prior to
- •randomization; patients must have recovered from all therapy-related toxicities
- •2. Chemotherapy = 3 weeks prior to randomization; patients must have recovered
- •from all therapy-related toxicities (grade 1 neuropathy after oxaliplatin
- •containing chemotherapy is allowed)
- •3. Biologic or immunotherapy = 6 weeks prior to randomization; patients must have
- •recovered from all therapy-related toxicities
- •4. Concurrent use of other investigational agents and patients who have received
- •investigational agents = 6 weeks prior to randomization
- •5. Concomitant use of proton pump inhibitors and H2-antagonists (please refer
- •also to section 6.1). The use of antacids taken at least 2 hours before or after
- •the study drug is allowed.
- •6. Major surgery = 4 weeks prior to randomization; minor surgery = 2 weeks prior
- •to randomization. Insertion of a vascular access device is not considered as
- •major or a minor surgery. Patients must have recovered from all surgery-related
- •toxicities.
- •7. Pleural effusion or ascites that causes = CTC grade 2 dyspnoea
- •8. History or clinical signs of central nervous system (CNS) disease (i.e., primary
- •brain tumor, malignant seizures, CNS metastases or carcinomatous meningitis)
- •9. Concurrent severe and / or uncontrolled medical disease (i.e., uncontrolled
- •diabetes, congestive cardiac failure, myocardial infarction within 6 months, poorly
- •controlled hypertension, history of labile hypertension, history of poor
- •compliance with antihypertensive regimen, chronic renal disease, chronic liver
- •disease, confirmed diagnosis of human immunodeficiency virus (HIV) infection or
- •active uncontrolled infection) or significant neurologic or psychiatric disorder,
- •which could compromise participation in the study
- •10. History of another primary malignancy = 5 years, with the exception of inactive
- •basal or squamous cell carcinoma of the skin or cervical cancer in situ
- •11. Long QT syndrome or baseline 12-lead electrocardiogram (ECG) QTcF greater
- •than 450 msec for males and 470 msec for females
- •12. Impairment of gastrointestinal (GI) function or GI disease that may significantly
- •alter the absorption of PTK/ZK (i.e., ulcerative disease, uncontrolled nausea,
- •vomiting, diarrhea, malabsorption syndrome, bowel obstruction, inability to
- •swallow the tablets)
- •13. Pregnant or breastfeeding females
- •14. Subjects of both sexes unwilling or unable to use a required barrier method of
- •contraception during participation1
- •15. Unwillingness or inability to comply with the study protocol
- •16. Previous assignment to treatment during this study
- •17. Presence of any condition excluding tumor scans by (DCE-) MRI (Attachment 2) or
研究者
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