ISRCTN66171897已完成1 期
A Phase I/II trial of AZD4547 in combination with cisplatin and capecitabine
HS Greater Glasgow and Clyde (UK)0 个研究点目标入组 158 人开始时间: 2012年3月14日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 158
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
- 性别
- All
入选标准
- •1. Male or female and over 25 years of age
- •2. Eastern Cooperative Oncology Group (ECOG) performance status 0, or 1
- •3. Written informed consent
- •4. No chemotherapy, hormonal therapy, immunotherapy, targeted systemic cancer therapy, or investigational therapy within 4 weeks of study entry (6 weeks for mitomycin C and nitrosureas)
- •5. No radiotherapy within 4 weeks of study entry.
- •6. Adequate haematological function, as follows:
- •6.1. Haemoglobin > 10g/dl
- •6.2. Neutrophils > 1.5 x 109/l
- •6.3. Platelets > 100 x 109/l
- •7. Adequate biochemical function, as follows:
- •7.1. Bilirubin < 1.5 x ULN (Upper Limit of Normal)
- •7.2. ALT or AST < 2.5 x ULN
- •7.3. Alkaline Phosphatase < 2.5 x ULN
- •7.4. Serum Phosphate < ULN
- •7.5. Serum Calcium < ULN
- •7.6. Serum Magnesium < ULN
- •8. Adequate renal function with creatinine clearance / glomerular filtration rate > 60 mls/min. If the creatinine clearance / glomerular filtration rate is less than 60 mls/min as calculated by the Cockroft-Gault formula, then the creatinine clearance / glomerular filtration rate should be measured by either a radio-isotope technique or by 24-hour urine collection
- •9. Life expectancy >12 weeks
- •10. Able to reliably tolerate and comply with oral medication
- •Additional stage 1 inclusion criteria:
- •1. Histologically or cytologically proven advanced solid tumour that is refractory to standard therapies, or for whom no standard therapies exist, or for whom cisplatin and capecitabine is an acceptable treatment option
- •2. No concomitant use of another anti-cancer therapy with the exception of patients with prostate cancer who are on a LHRH analogue who can continue this during the study
- •3. Disease which is either measurable (RECIST 1.1) or evaluable
- •Additional stage 2 inclusion criteria:
- •1. Histologically or cytologically proven adenocarcinoma or undifferentiated carcinoma of the oesophagus, gastro-oesophageal junction, or stomach
- •2. Locally advanced (inoperable) disease (that is not suitable for a combined chemo-radiation approach for tumours confined to the lower oesophagus) or metastatic disease
- •3. Tumours with FGFR2 polysomy or amplification (FISH 4/5 or FISH 6)
- •4. No prior neo-adjuvant or adjuvant chemotherapy, and no prior chemotherapy for advanced disease
- •5. No concomitant use of another anti-cancer therapy during the study
- •6. At least one bi-dimensional measurable lesion as defined by RECIST 1.1
排除标准
- •1. History of physical or psychiatric disorder that would prevent informed consent and compliance
- •2. Pregnant or lactating women
- •3. Fertile woman of childbearing potential not willing to use adequate contraception (oral contraceptives, intrauterine device or barrier method of contraception in conjunction with spermicidal jelly or surgically sterile) for the study duration and at least six months afterwards. It is not known whether AZD4547 can induce hepatic enzymes. If oral contraception is used, it is recommended that this is used in combination with a barrier method as well. Fertile men who are not willing to use a barrier method of contraception (condoms with spermicidal jelly). Fertile men should also refrain from donating sperm from the start of dosing until 16 weeks after discontinuing study treatment. Male patients wishing to subsequently father children should attend for freezing of sperm samples prior to dosing.
- •4. Evidence of uncontrolled infection (defined as infection that cannot be resolved readily with antibiotics prior to patient entry into the trial)
- •5. Major surgery within 28 days prior to study entry or anticipated to occur while on study
- •6. Prolonged QTc (corrected) interval of > 470ms on ECG or a family history of long QT syndrome
- •7. History of active or treated brain metastases (with the exception of patients with resected brain metastases and no evidence of recurrence on CT or MRI of the brain)
- •8. CNS disease (uncontrolled seizures or cerebrovascular accident/transient ischaemic attack /subarachnoid haemorrhage within 6 months)
- •9. Any unresolved toxicity CTC Grade 1 from previous systemic anti-cancer therapy except alopecia
- •10. Pre-existing sensory or motor neuropathy ¡Ý grade 1
- •11. Known hypersensitivity to cisplatin
- •12. Known DPD deficiency or hypersensitivity to capecitabine
- •13. Known hypersensitivity to AZD4547
- •14. History of significant cardiac disease including myocardial infarction within the previous 6 months, uncontrolled ischaemic heart disease, second or third degree heart block, any other persistent or intermittent cardiac arrhythmia requiring medication, congestive cardiac failure > NYHA Grade 2 (Appendix 3), or left ventricular ejection fraction of < 50%
- •15. Patients with a lack of physical integrity of the GI tract leading to a malabsorption syndrome or intestinal obstruction
- •16. Evidence of any other disease, metabolic dysfunction, physical examination finding or laboratory finding giving reasonable suspicion of a disease or condition that contra-indicates the use of an investigational drug or puts the patient at high risk for treatment-related complications
- •17. Patients with significant hearing loss such that Cisplatin is contra-indicated
- •18. Patients taking CYP3A4 and CYP2D6 inducers or inhibitors
- •19. Current evidence or previous history of retinal pigmented epithelium detachment (RPED)
- •20. Previous laser treatment or intra-ocular injection for treatment of macular degeneration
- •21. Current evidence or previous history of dry or wet age-related macular degeneration
- •22. Current evidence or previous history of retinal vein occlusion (RVO)
- •23. Current evidence or previous history of retinal degenerative diseases (e.g. hereditary)
- •24. Current evidence or previous history of any other clinically relevant chorioretinal defect
- •Additional Stage 2 exclusion criteria:
- •History of prior malignancy within the last 5 years other than patients with basal cell carcinoma of the skin or in situ neoplasia of t
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