A Phase III, Open Label, Randomised, Controlled, Multi-Centre Study To Assess the Efficacy and Safety of Savolitinib versus Sunitinib in Patients with MET-Driven, Unresectable/Locally Advanced Or Metastatic Papillary Renal Cell Carcinoma (PRCC) - A phase III study to compare the efficacy and safety of a new anticancer medication, Savolitinib, wi

ASTRAZENECA SPA0 个研究点目标入组 180 人开始时间: 2020年2月11日最近更新: 2021年8月17日

适应症

试验速览

暂无简介。

•1. Histologically confirmed PRCC, which is unresectable/locally advanced or metastatic with measurable disease as per RECIST 1.1.
•2. Confirmation of MET-driven PRCC without co-occurring FH or VHL mutations from an FFPE tumour sample using the sponsor-designated central laboratory
•validated MET NGS assay
•3. Patients who have received no prior systemic therapy as well as those who have received prior systemic therapy for PRCC
•4. Adequate haematological, renal, cardiac and liver functions
•5. Karnofsky performance status = 80
•Are the trial subjects under 18? no
•Number of subjects for this age range: 1
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 90
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 90

•1. Most recent cytotoxic chemotherapy, immunotherapy, chemo-immunotherapy, or investigational agents <21 days from the date of randomisation or 5 half-lives of the agent, whichever is longer. Most recent non-cytotoxic targeted therapy <14 days from the date of randomisation.
•2. Prior treatment with a MET inhibitor (e.g. foretinib, crizotinib, cabozantinib, onartuzumab or previous savolitinib) or sunitinb.
•3. Treatment with strong inducers or inhibitors of CYP3A4 or strong inhibitors of CYP1A2, taken within 2 weeks or not possible to be stopped for at least 2 week before the date of randomisation. Herbal medications cannot be taken within 7 days of the date of randomisation (3 weeks for St John’s wort).
•3. Wide field radiotherapy administered =28 days or limited field radiation for palliation =7 days prior to the date of randomisation
•4. Major surgical procedures =28 days of randomisation or minor surgical procedures =7 days. No waiting is required following port-a-cath placement.
•5. Previously untreated brain metastases
•6. Serious active infection or gastrointestinal disease
•7. Presence of other active cancers, or history of treatment for invasive cancer within the last 5 years.

发起方