EUCTR2015-003965-27-GB进行中（未招募）1 期
A phase I dose escalation safety study combining the ATR inhibitor M6620 with chemoradiotherapy in oesophageal cancer & other sold cancers using time to event continual reassessment method - M6620 plus standard treatment in oesophageal and other cancer
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 65
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
入选标准
- •Inclusion Criteria:
- •1. Any gender, age 16 years or over
- •2. Life expectancy of at least 12 weeks (N/A Stage B)
- •3. ECOG performance score of 0-1
- •4. Able to comply with protocol fully - absence of any physical, psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial
- •5. Able to give written (signed and dated) informed consent according to GCP before registration
- •6. Haematological and biochemical indices: Platelet count = 100 x 10^9/L; Absolute neutrophil count (ANC) = 1.5 x 10^9/L; Total bilirubin = 1.5 x upper limit of normal unless the subject has known or suspected Gilbert’s syndrome; AST (SGOT)/ALT (SGPT) = 2.5 x upper limit of normal; =5 X ULN if liver metastases
- •Additional for Stage A1
- •1. Histologically confirmed adenocarcinoma or squamous cell carcinoma of the oesophagus(not including cervical oesophagous)
- •2. Tumour length 10 cm or less
- •3. Any stage of disease that is unsuitable for radical CRT or surgery but suitable for palliative RT
- •4. Baseline investigations available: staging CT scan (up to 42 days before first study dose) and endoscopy
- •5. No oesophageal stent in situ
- •6. Haemoglobin (Hb) = 8.0 g/dL
- •7. Estimated glomerular filtration rate =40mL/min
- •8. Previous chemotherapy treatment completed 28 days before first study dose
- •Additional for Stage A2
- •1. Any histologically confirmed advanced solid tumour that is metastatic or unresectable where investigator considers Cisplatin and Capecitabine based regimen as appropriate
- •2. Baseline investigations available: staging CT scan (up to 35 days before first study dose)
- •3. Haemoglobin (Hb) = 10.0 g/dL
- •4. Estimated glomerular filtration rate =60mL/min
- •5. Previous chemotherapy treatment completed 28 days before first study dose
- •6. Calcium, magnesium and phosphate within normal limits
- •Additional for Stage B
- •1. Histologically confirmed adenocarcinoma or squamous cell carcinoma of the oesophagus including Siewert type 1 or 2 tumours with =2cm gastric mucosal extension (not including cervical oesophagous).
- •2. Tumour length 7cm or less.
- •3. Suitable for radical CRT and surgery not an option due to being medically unfit or unsuitable for surgery or patient choice.
- •4. No oesophageal stent in situ.
- •5. Endoscopically or radiologically documented measureable disease.
- •6. Diagnostic PET CT scan*
- •7. Staging CT scan*
- •*either CT or PET CT within 42 days of first study dose
- •8. Adequate respiratory and cardiac function tests for safe delivery of CRT in the opinion of the Principal Investigator, specifically cardiac ejection fraction =60% and lung function FEV1 >1 litre or 40% of predicted value or KCO (DLCO/VA) > 40% predicted value
- •9. Haemoglobin (Hb) 10.0 g/dL
- •10. Estimated glomerular filtration rate =60mL/min
- •11. Calcium, magnesium and phosphate within normal limi
排除标准
- •A patient will not be eligible for the trial if any of the following apply:
- •1. Pregnant or breast-feeding women, or women of childbearing potential unless effective methods of contraception are used
- •2. Brain metastases
- •3. Clinically significant cardiovascular event within 6 months before study entry to include:
- •a.congestive heart failure requiring therapy
- •b.unstable angina pectoris
- •c.myocardial infarction
- •d.Class II/III/IV cardiac disease (New York Heart Association)
- •e.presence of severe valvular heart disease;
- •f.presence of a ventricular arrhythmia requiring treatment
- •4. History of arrhythmia that is symptomatic or requires treatment (CTCAE 3), symptomatic or uncontrolled atrial fibrillation, despite treatment, or asymptomatic sustained ventricular tachycardia. Subjects with atrial fibrillation controlled by medication are permitted
- •5. Uncontrolled hypertension (blood pressure =160/100 despite optimal therapy)
- •6. Second or third degree heart block with or without symptoms
- •7. QTc >450 msec in adult male and >470 msec in adult females (by either Fridericia’s or Bazett’s correction) not due to electrolyte abnormality and that does not resolve with correction of electrolytes
- •8. History of congenital long QT syndrome
- •9. History of torsades de pointes (or any concurrent medication with a known risk of inducing torsades de pointes)
- •10. Trachea-oesophageal fistula or invasion of the tracheo-bronchial tree
- •11. Treatment with any other investigational agent, or participation in another clinical trial within 28 days prior to enrolment
- •12. Strong CYP3A inhibitors and inducers or Haemopoetic growth factors within 14 days before first dose M6620
- •13. HER2 gastro-oesophageal positive cancer where anti-Her2 therapies may be more appropriate (however patients who have failed anti-HER2 therapy may be eligible for stage A1 and A2)
- •14. Unable to have or unwilling to change to low molecular weight heparin instead of Warfarin.
- •15. Other psychological, social or medical condition, physical examination finding or a laboratory abnormality that the Investigator considers would make the patient a poor trial candidate or could interfere with protocol compliance or the interpretation of trial results
- •16. Any other active malignancy, with the exception of adequately treated cone-biopsied in situ carcinoma of the cervix uteri and non-melanoma skin lesions
- •17. Patients who are known to be serologically positive for Hepatitis B, Hepatitis C or HIV
- •Additional exclusion criteria Stage A1 and B
- •1.Previous radiotherapy to thorax or upper abdomen
- •Additional exclusion criteria Stage A2 and B
- •1. History of hand-foot syndrome
- •2. History of hearing impairment
- •3. Live vaccine received within 30 days prior to treatment start
- •Additional exclusion criteria Stage B
- •1.Previous chemotherapy
研究者
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