ISRCTN10361292已完成1 期
A Phase I study of olaparib in combination with chemoradiation in locally advanced pancreatic cancer
HS Greater Glasgow and Clyde0 个研究点目标入组 42 人开始时间: 2015年4月20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
- 42
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. Histologically or cytologically confirmed locally advanced inoperable pancreatic ductal adenocarcinoma
- •2. Patients with clearly un-resectable disease on anatomical criteria as determined by a multi-disciplinary team and considered to be candidates for combined modality treatment with chemo-radiation
- •3. Patients must have had a partial response or stable disease following 3 cycles of induction chemotherapy with gemcitabine and capecitabine as described in Appendix 1, and have a tumour diameter of 6cm or less
- •4. Performance status = 1 (ECOG, Appendix 3)
- •5. Age = 16 years
- •6. Evaluable or measurable disease
- •7. Estimated life expectancy greater than 3 months
- •8. Adequate haematological function as defined by:
- •8.1. Haemoglobin (Hb) > 10g/dl (no blood transfusions in the 28 days prior to trial entry)
- •8.2. Neutrophil Count > 1.5 x 109/l (no features suggestive of MDS/AML on peripheral blood smear)
- •8.3. White Blood Cells (WBC) >3x109/L
- •8.4. Platelets > 100 x 109/l
- •8.5. Bilirubin < 1.5 x upper limit of normal (ULN)
- •8.6. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) < 2.5 x ULN
- •8.7. Adequate renal function with creatinine clearance / glomerular filtration rate > 50 ml/min. If the creatinine clearance / glomerular filtration rate is less than 50 ml/min as calculated by the Cockcroft-Gault/Wright formula, then the creatinine clearance / glomerular filtration rate should be measured by either a radio-isotope technique or by 24-hour urine collection
- •9. Able to swallow oral tablets/capsules
- •10. Able to comply with study procedures
- •11. Written informed consent
- •12. Evidence of non-childbearing status for women of childbearing potential: negative urine or serum pregnancy test within 7 days of trial treatment
- •13. Postmenopausal as defined as:
- •13.1. Amenorrheic for 1 year or more following cessation of exogenous hormonal treatments,
- •13.2. LH and FSH levels in the post-menopausal range for women under 50,
- •13.3. Surgical sterilisation (bilateral oophorectomy or hysterectomy).
- •Dose Expansion Cohort
- •Additional Eligibility Criteria
- •1. Patients with pancreatic ductal adenocarcinoma who are considered by a multi-disciplinary team to have borderline” resectable disease based on their anatomical findings during pre-operative staging
排除标准
- •1. Any prior anti-cancer therapy for pancreatic cancer including chemotherapy, radiotherapy, endocrine therapy, immunotherapy or use of other investigational agents (except induction chemotherapy)
- •2. Patients with known metastatic disease
- •3. Pregnant or lactating women
- •4. Women of childbearing age and potential who are not willing to use an two highly effective methods of contraception as detailed in section 11.3. Male patients of childbearing potential will also be excluded if either they or their female partner are not willing to use two highly effective methods of contraception as detailed in section 11.3. In addition, both of the above will be excluded if they are not willing to use contraception for 12 months after the last dose. Men with pregnant or lactating partners should be advised to user barrier contraception to prevent exposure to the foetus or neonate.
- •5. Patients who are known to be HIV positive, or who are known to have positive Hepatitis B or C serology
- •6. Any evidence of uncontrolled cardiac disease or any other serious medical or psychiatric disorder that would be, in the opinion of the investigator, a contra-indication to either the trial procedures or to therapy with olaparib or capecitabine
- •7. Patients with second or third degree heart block, family history of QT prolongation or shortening, history of arrhythmia, or familial sudden death or QT interval at screening of >450 ms (male) / >470 ms (female)
- •8. Patients receiving concomitant medications known to cause QT prolongation
- •9. Patients with known DPD deficiency
- •10. Patients with a lack of physical integrity of the GI tract leading to a malabsorption syndrome or intestinal obstruction that would impair the administration and absorption of oral therapy
- •11. Participation in another clinical trial with an investigational product during the last 12 months
- •12. Any previous treatment with a PARP inhibitor, including olaparib.
- •13. Concomitant use of known CYP3A4 inhibitors such as ketoconazole, itraconazole, ritonavir, indinavir, saquinavir, telithromycin, clarithromycin and nelfinavir. In addition , to avoid potential reductions in exposure due to drug interactions and, therefore, a potential reduction in efficacy, the following CYP3A4 inducers are excluded: Phenytoin, fiampicin, rifapentin, rifabutin, carbamazepine, phenobarbitone, nevirapine, modafinil and St John’s Wort (Hypericum perforatum; wash-out period for phenobarbitone 5 weeks and for any of the others 3 weeks)
- •14. Blood transfusions within 1 month prior to trial start
- •15. Patients with myelodysplastic syndrome/acute myeloid leukaemia
- •16. Major surgery within 14 days of starting trial treatment and patients must have recovered from any effects of major surgery
- •17. Patients with a known hypersensitivity to olaparib or any of the excipients of the product
- •18. Patients with uncontrolled seizures
- •19. Patients with grade III / IV non-haematological toxicity related to capecitabine during induction chemotherapy except for alopecia or nausea and vomiting unless not controlled with maximal anti-emetics support
- •20. Patients unable to tolerate standard dose of capecitabine during induction chemotherapy
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