EUCTR2006-004824-35-FR进行中（未招募）1 期
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
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Schering AG
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 guidelines
- •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
- •6. At least 1 measurable liver lesion with the size of at least 3 cm for DCE-MRI evaluation
- •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 participation
- •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 CT
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