EUCTR2009-017171-13-GB进行中（未招募）1 期
A randomised placebo-controlled trial of saracatinib (AZD0530) plus weekly paclitaxel in platinum-resistant ovarian, fallopian tube or primary peritoneal cancer. - SaPPrOC
niversity College London0 个研究点目标入组 107 人开始时间: 2010年8月6日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 107
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
- •Histologically or cytologically confirmed ovarian, fallopian tube or primary peritoneal cancer
- •Confirmed relapsed disease AND relapse within the platinum-resistant (progression must not be based on CA125 alone) time-frame, i.e. have progressed within 6 months of platinum therapy. Relapse should ideally have been confirmed radiologically with measurable disease, but patients with CA125 progression plus symptoms indicative of progression will also be allowed to enter
- •Patients with synchronous tumours e.g. ovarian and endometrial or history of prior malignancy are eligible provided that there is biopsy evidence that the disease measurable on CT and/or MRI is ovarian in origin.
- •Patients must have archival formalin-fixed paraffin-embedded tissue (or cytological block) from their original diagnosis available for the purposes of translational research (see point sections 4.2 and 20.0)
- •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 <6 months or =6 months taxane interval/no prior taxane.
- •Patients will generally have received at least 2 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.
- •Measurable or evaluable disease (if not measurable by RECIST v1.1 criteria, patients must be evaluable by GCIG CA125 criteria). See Appendices 3-6.
- •ECOG PS 0-2
- •Adequate haematological and biochemical function as follows:
- •Neutrophil count > 1.5 x 109/l
- •Platelet count > 100 x 109/l
- •Hb > 9.0 g/dl
- •Serum creatinine < 1.5 x Upper Limit of Normal (ULN)
- •Bilirubin = 1.5 x ULN. In cases of known Gilbert’s syndrome, bilirubin = 2 x ULN is allowed
- •AST or ALT = 2.5 x ULN
- •Alkaline phosphatase < 5 x ULN
- •Prothrombin and activated partial thromboplastin times < 1.5 x ULN (NB values accepted in the form of ratio rather than in seconds where site’s local practice does not give the values in seconds)
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 0
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 0
排除标准
- •Prior administration of weekly paclitaxel.
- •Tumours of malignant mixed mesodermal (MMMT) or mucinous subtypes, or non-epithelial ovarian cancers (e.g. Brenner tumours, Sex-cord tumours).
- •Synchronous primary tumours e.g. ovarian and endometrial with no biopsy evidence of measurable disease of ovarian origin.
- •Unresolved bowel obstruction.
- •Chemotherapy within the preceding 3 weeks.
- •Radiotherapy within the preceding 3 weeks.
- •Treatment with any investigational agent within the preceding 4 weeks or within 5 half-lives of the investigational agent, whichever is longer.
- •Known leptomeningeal involvement or intracranial disease.
- •Evidence of interstitial lung disease (bilateral, diffuse, parenchymal lung disease).
- •Resting ECG with measurable QTc interval of >480 msec at 2 or more time points within a 24 hour period.
- •Pregnant or lactating females.
- •Fertile women of childbearing potential not willing to use highly effective contraception for the duration of trial treatment and for at least 6 months after the last administration of saracatinib +/- paclitaxel (as per 5.3.3).
- •Inability or unwillingness to give informed consent.
- •Ongoing active infection or a documented history of HIV infection, Hepatitis B or C.
- •Concurrent congestive heart failure or prior history of New York Heart Association (NYHA) class III/IV cardiac disease (see Appendix 8).
- •Concurrent autoimmune disorder, e.g. systemic lupus or any demyelinating disease.
- •Use of immunosuppressive therapy taken within 4 weeks of study entry.
研究者
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