ISRCTN32163062已完成2 期
A randomised placebo-controlled trial of saracatinib (AZD0530) plus weekly paclitaxel in platinum-resistant ovarian, fallopian tube or primary peritoneal cancer
niversity College London (UCL) (UK)0 个研究点目标入组 107 人开始时间: 2010年10月29日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 107
研究概览
简要总结
2014 Results article in http://www.ncbi.nlm.nih.gov/pubmed/25070546 results
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- Female
入选标准
- •1. Confirmed relapsed ovarian, fallopian tube or primary peritoneal cancer AND patients who have relapsed in the platinum-resistant (progression must not be based on CA125 alone) time-frame, i.e. have progressed within 6 months of platinum therapy
- •2. All patients must have formalin-fixed paraffin-embedded (FFPE) tissue available for translational research: this tissue may be tissue taken at original diagnosis
- •3. Patients need not have received prior taxane; if patients have received prior taxane, the interval since treatment must be known. Patients will be stratified as less than 6 months OR at least 6 months taxane interval/no prior taxane.
- •4. Patients will generally have received at least two lines of prior chemotherapy, but may enter if they have relapsed within 6 months of first-line therapy. Patients may have received prior liposomal doxorubicin, although this is NOT a requirement. The treatment immediately prior to study entry need not be platinum-based.
- •5. Measurable or evaluable disease (if not measurable by Response Evaluation Criteria in Solid Tumours version 1.1 [RECIST v1.1] criteria, must be evaluable by CA125 [GCIG criteria])
- •6. Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 - 2
- •7. Adequate haematological and biochemical function as follows:
- •7.1. Granulocyte count greater than 1.5 x 10^9/l
- •7.2. Platelet count greater than 100 x 10^9/l
- •7.3. Haemoglobin (Hb) greater than 9.0 g/dl
- •7.4. Serum creatinine less than 1.5 x upper limit of normal (ULN)
- •7.5. Bilirubin less than 1.5 x ULN. In cases of known Gilbert's syndrome, bilirubin less than 2 x ULN is allowed
- •7.6. Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) less than 2.5 x ULN
- •7.7. Alkaline phosphatase (ALP) less than 5 x ULN
- •7.8. Prothrombin and activated partial thromboplastin times less than 1.5 x ULN
- •8. Willingness to consent to take part in Level 1 of the translational sub-study, as per section 19.0 of the protocol (this is NOT optional)
排除标准
- •1. Prior administration of weekly paclitaxel
- •2. Tumours of malignant mixed mesodermal (MMMT) or mucinous types
- •3. Unresolved bowel obstruction
- •4. Chemotherapy within the preceding 3 weeks
- •5. Radiotherapy within the preceding 3 weeks
- •6. Treatment with any investigational agent within the preceding 4 weeks or within 5 half-lives of the investigational agent, whichever is longer
- •7. Known leptomeningeal involvement or intracranial disease
- •8. Evidence of interstitial lung disease (bilateral, diffuse, parenchymal lung disease)
- •9. Resting electrocardiogram (ECG) with measurable QTc interval of greater than 480 msec at two or more time points within a 24-hour period
- •10. Pregnant or lactating females
- •11. Fertile women of childbearing potential not willing to use adequate contraception for the duration of trial treatment and for at least 30 days after the last administration of saracatinib +/- paclitaxel
- •12. Inability or unwillingness to give informed consent
- •13. Ongoing active infection or a documented history of human immunodeficiency virus (HIV) infection, hepatitis B or C
- •14. Concurrent congestive heart failure or prior history of New York Heart Association (NYHA) class III/IV cardiac disease
- •15. Concurrent autoimmune disorder, e.g. systemic lupus or any demyelinating disease
- •16. Use of immunosuppressive therapy or corticosteroids taken within the 4 weeks prior to study entry and during the treatment period
研究者
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