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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT05043090
Registration number
NCT05043090
Ethics application status
Date submitted
11/08/2021
Date registered
13/09/2021
Titles & IDs
Public title
Savolitinib Plus Durvalumab Versus Sunitinib and Durvalumab Monotherapy in MET-Driven, Unresectable and Locally Advanced or Metastatic PRCC
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Scientific title
A Phase III, Open Label, Randomised, 3-Arm, Multi-Centre Study of Savolitinib Plus Durvalumab Versus Sunitinib and Durvalumab Monotherapy in MET-Driven, Unresectable and Locally Advanced or Metastatic Papillary Renal Cell Carcinoma (SAMETA)
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Secondary ID [1]
0
0
2021-000336-55
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Secondary ID [2]
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0
D5086C00001
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Universal Trial Number (UTN)
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Trial acronym
SAMETA
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Papillary Renal Cell Carcinoma
0
0
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Condition category
Condition code
Cancer
0
0
0
0
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Non melanoma skin cancer
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Cancer
0
0
0
0
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Kidney
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - savolitinib
Treatment: Drugs - durvalumab
Treatment: Drugs - sunitinib
Experimental: Arm A - savolitinib 600mg plus durvalumab 1500mg
Active comparator: Arm B - sunitinib 50mg
Experimental: Arm C - durvalumab 1500mg
Treatment: Drugs: savolitinib
Tablets : 3 × 200 mg tablets once daily
Treatment: Drugs: durvalumab
Concentrate for solution for IV infusion : 1500 mg durvalumab every 4 weeks
Treatment: Drugs: sunitinib
Capsules : 2 x 25mg capsules once daily 4 weeks on, 2 weeks off
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Progression-Free Survival (PFS) /savolitinib plus durvalumab relative to sunitinib
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Assessment method [1]
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Defined as time from randomisation until progression per RECIST 1.1 as assessed by BICR, or death due to any cause.
The analysis will include all randomised participants as randomised, regardless of whether the participant withdraws from therapy, receives another anti-cancer therapy or clinically progresses prior to RECIST 1.1 progression.
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Timepoint [1]
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Approximately 28 months post first subject randomized
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Secondary outcome [1]
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Overall Survival (OS) /savolitinib plus durvalumab relative to sunitinib
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Assessment method [1]
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0
Defined as time from randomisation until the date of death due to any cause. The comparison will include all randomised participants as randomised regardless of whether the participant withdraws from therapy or receives another anti-cancer therapy.
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Timepoint [1]
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Approximately 28 months and approximately 42 months post first subject randomized
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Secondary outcome [2]
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Objective Response Rate (ORR) / savolitinib plus durvalumab relative to sunitinib
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Assessment method [2]
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Defined as the proportion of participants who have a Complete Response (CR) or Partial Response (PR) as determined by BICR per RECIST 1.1.
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Timepoint [2]
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0
Approximately 28 months post first subject randomized
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Secondary outcome [3]
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0
Duration of Response (DoR) / savolitinib plus durvalumab relative to sunitinib
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Assessment method [3]
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Defined as the time from the date of first documented response until date of documented progression per RECIST 1.1 as assessed by BICR or death due to any cause.
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Timepoint [3]
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0
Approximately 28 months post first subject randomized
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Secondary outcome [4]
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Disease Control Rate (DCR) at 24 and 48 weeks /savolitinib plus durvalumab relative to sunitinib
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Assessment method [4]
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Defined as the percentage of participants who have a CR or PR or who have Stable Disease (SD) per RECIST 1.1 as assessed by BICR for at least 23 or 47 weeks, respectively after randomisation.
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Timepoint [4]
0
0
Approximately 28 months post first subject randomized
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Secondary outcome [5]
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0
Time from randomisation to second progression or death (PFS2) /savolitinib plus durvalumab relative to sunitinib
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Assessment method [5]
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0
Defined as time from randomisation to the earliest of the progression event (following the initial progression), subsequent to the first subsequent therapy or death.
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Timepoint [5]
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Approximately 28 months and 42 months post first subject randomized
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Secondary outcome [6]
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Assessment of patient-reported symptoms, functioning, and HRQoL /savolitinib plus durvalumab relative to sunitinib
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Assessment method [6]
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Time to deterioration and change from baseline in symptoms, functioning, and HRQoL as measured by FKSI-19.
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Timepoint [6]
0
0
Approximately 28 months post first subject randomized
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Secondary outcome [7]
0
0
Objective Response Rate (ORR) / savolitinib plus durvalumab relative to durvalumab monotherapy
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Assessment method [7]
0
0
Defined as the proportion of participants who have a Complete Response (CR) or Partial Response (PR) as determined by BICR per RECIST 1.1
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Timepoint [7]
0
0
Approximately 28 months post first subject randomized
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Secondary outcome [8]
0
0
Duration of Response (DoR) / savolitinib plus durvalumab relative to durvalumab monotherapy
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Assessment method [8]
0
0
Defined as the time from the date of first documented response until date of documented progression per RECIST 1.1 as assessed by BICR or death due to any cause.
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Timepoint [8]
0
0
Approximately 28 months post first subject randomized
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Secondary outcome [9]
0
0
Progression-Free Survival (PFS) /savolitinib plus durvalumab relative to durvalumab monotherapy
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Assessment method [9]
0
0
Defined as time from randomisation until progression per RECIST 1.1 as assessed by BICR, or death due to any cause.
The analysis will include all randomised participants as randomised, regardless of whether the participant withdraws from therapy, receives another anti-cancer therapy or clinically progresses prior to RECIST 1.1 progression.
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Timepoint [9]
0
0
Approximately 28 months post first subject randomized
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Secondary outcome [10]
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0
Evaluation of the PK of savolitinib pre-dose
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Assessment method [10]
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Plasma concentration of savolitinib and its metabolites pre-dose (Ctrough / trough plasma concentration : measured concentration at the end of a dosing interval at steady state \[taken directly before next administration\]) in participants randomised to savolitinib plus durvalumab.
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Timepoint [10]
0
0
Approximately 28 months post first subject randomized
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Secondary outcome [11]
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0
Evaluation of the PK of savolitinib post-dose
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Assessment method [11]
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0
Plasma concentration of savolitinib and its metabolites post-dose (C1h and C3h) in participants randomised to savolitinib plus durvalumab.
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Timepoint [11]
0
0
Approximately 28 months post first subject randomized
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Secondary outcome [12]
0
0
Evaluation of the PK of durvalumab pre-dose
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Assessment method [12]
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Serum concentration of durvalumab pre-dose (Ctrough / trough plasma concentration : measured concentration at the end of a dosing interval at steady state \[taken directly before next administration\]) in participants randomised to savolitinib plus durvalumab or durvalumab monotherapy.
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Timepoint [12]
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0
Approximately 28 months post first subject randomized
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Secondary outcome [13]
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0
Evaluation of the PK of durvalumab / Cmax (maximum plasma concentration)
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Assessment method [13]
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0
Serum concentration of durvalumab at the end of infusion (Cmax) in participants randomised to savolitinib plus durvalumab or durvalumab monotherapy.
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Timepoint [13]
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Approximately 28 months post first subject randomized
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Eligibility
Key inclusion criteria
* Histologically confirmed unresectable and locally advanced or metastatic PRCC
* PRCC must be centrally confirmed as MET-driven using a sponsor-designated central laboratory validated NGS assay
* No prior systemic anti-cancer treatment in the metastatic setting; no prior exposure to MET inhibitors, Durvalumab or Sunitinib in any setting
* Karnofsky Score >70
* At least one lesion, not previously irradiated, that can be accurately measured at baseline
* Adequate organ and bone marrow function
* Life expectancy =12weeks at Day 1
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Minimum age
18
Years
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Maximum age
130
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* History of liver cirrhosis of any origin and clinical stage; or history of other serious liver disease or chronic disease with relevant liver involvement, with or without normal LFTs
* Spinal cord compression or brain metastases, unless asymptomatic and stable on treatment for at least 14 days prior to study intervention
* Active or prior cardiac disease (within past 6 months) or clinically significant ECG abnormalities and/or factors/medications that may affect QT and/or QTc intervals
* Active infection including HIV, TB, HBV and HCV
* Active or prior documented autoimmune or inflammatory disorders
* Receipt of live attenuated vaccine within 30 days prior to the first dose of study intervention
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
28/10/2021
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
12/06/2026
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Actual
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Sample size
Target
220
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Research Site - Box Hill
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Recruitment hospital [2]
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Research Site - Macquarie University
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Recruitment hospital [3]
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Research Site - Malvern
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Recruitment hospital [4]
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Research Site - St Leonards
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Recruitment postcode(s) [1]
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3128 - Box Hill
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Recruitment postcode(s) [2]
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2109 - Macquarie University
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Recruitment postcode(s) [3]
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3144 - Malvern
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Recruitment postcode(s) [4]
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2065 - St Leonards
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Recruitment outside Australia
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California
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Illinois
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Maryland
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New York
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Argentina
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Buenos Aires
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Caba
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Ciudad Autonoma Buenos Aires
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Argentina
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Ciudad Autónoma Buenos Aires
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Cordoba
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La Plata
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Rosario
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San Miguel de Tucuman
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Toluca De Lerdo
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Netherlands
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Amsterdam
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Netherlands
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Arnhem
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Country [107]
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Netherlands
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State/province [107]
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Rotterdam
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Poland
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State/province [108]
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Gdansk
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Country [109]
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Poland
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State/province [109]
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Gdynia
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Country [110]
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Poland
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Kraków
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Country [111]
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Poland
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Otwock
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Country [112]
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Poland
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State/province [112]
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Poznan
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Country [113]
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Poland
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Warsaw
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Country [114]
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Romania
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State/province [114]
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Baia Mare
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Country [115]
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Romania
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State/province [115]
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Cluj Napoca
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Country [116]
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Romania
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State/province [116]
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Cluj-Napoca
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Romania
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Constanta
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Country [118]
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Romania
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Craiova
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Romania
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Iasi
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Russian Federation
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Arkhangelsk
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Russian Federation
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Ekaterinburg
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Russian Federation
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Krasnoyarsk
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Russian Federation
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Kursk
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Russian Federation
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Kuzmolovskiy
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Russian Federation
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Moscow
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Russian Federation
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Omsk
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Russian Federation
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Saint Petersburg
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Russian Federation
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St-Petersburg
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Singapore
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Singapore
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Slovakia
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Trencin
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Spain
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Barcelona
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Spain
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Cordoba
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Country [133]
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Spain
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Coruña
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Spain
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Madrid
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Spain
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Majadahonda
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Spain
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Málaga
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Spain
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Pamplona
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Country [138]
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Spain
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Sabadell
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Country [139]
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Spain
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Sevilla
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Country [140]
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Spain
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Valencia
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Country [141]
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0
Taiwan
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State/province [141]
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Kaohsiung City
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Country [142]
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Taiwan
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State/province [142]
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Taichung
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Country [143]
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Taiwan
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Tainan
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Turkey
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Adana
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Country [145]
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Turkey
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Ankara
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Turkey
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Edirne
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Turkey
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Istanbul
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Turkey
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Izmir
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Turkey
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State/province [149]
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Karsiyaka
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Turkey
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State/province [150]
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Kazimkarabekir
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Ukraine
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Chernivts?
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Ukraine
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Dnipropetrovsk
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Country [153]
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Ukraine
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Ivano-Frankivsk
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Country [154]
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Ukraine
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Kharkiv
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Country [155]
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Ukraine
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Kyiv
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Ukraine
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State/province [156]
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Poltava
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Country [157]
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Ukraine
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State/province [157]
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Zaporizhzhia
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Country [158]
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United Kingdom
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State/province [158]
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Leicester
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Country [159]
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United Kingdom
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State/province [159]
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London
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
AstraZeneca
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
A clinical trial to compare the effectiveness of savolitinib plus durvalumab versus sunitinib in MET-driven (hepatocyte growth factor receptor), unresectable and locally advanced or metastatic PRCC (Papillary Renal Cell Carcinoma).
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Trial website
https://clinicaltrials.gov/study/NCT05043090
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Toni Choueiri
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Address
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Dana-Farber Cancer Institute
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0
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Phone
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0
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Fax
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0
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Email
0
0
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Contact person for public queries
Name
0
0
AstraZeneca Clinical Study Information Center
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Address
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0
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Country
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0
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Phone
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1-877-240-9479
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Fax
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0
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Email
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[email protected]
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
Supporting document/s available: Study protocol, Statistical analysis plan (SAP)
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When will data be available (start and end dates)?
AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
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Available to whom?
When a request has been approved AstraZeneca will provide access to the deidentified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
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Available for what types of analyses?
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How or where can data be obtained?
IPD available at link: https://astrazenecagroup-dt.pharmacm.com/DT/Home
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT05043090