A phase III study to compare the efficacy and safety of a new anticancer medication, Savolitinib, with another medication, Sunitinib, in patients with a kind of papillary renal cell carcinoma (PRCC) that is considered MET-driven” based on defined genetic abnormalities and cannot be completely surgically removed and/or has spread to at least one other part of the body
- Conditions
- papillary renal cell carcinoma (PRCC)MedDRA version: 20.1Level: LLTClassification code 10023400Term: Kidney cancerSystem Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2016-004108-73-IT
- Lead Sponsor
- ASTRAZENECA SPA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 180
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method