Trial · NCT03091192

Savolitinib vs. Sunitinib in MET-driven PRCC.

NCT03091192, Phase 3, Active not recruiting, AstraZeneca; results first posted 2020-07-10

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Savolitinib vs. Sunitinib in MET-driven PRCC. Trials, record NCT03091192. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03091192

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Savolitinib vs. Sunitinib in MET-driven PRCC.
NCT number: NCT03091192
Status: Active not recruiting
Phases: Phase 3
Enrollment: 60 participants, actual
Lead sponsor: AstraZeneca
Conditions: Carcinoma, Carcinoma, Renal Cell, Kidney Neoplasms, Urologic Neoplasms, Kidney Diseases, Neoplasms by Site, Enzyme Inhibitors, Protein Kinase Inhibitors
Interventions: Savolitinib, Sunitinib
First posted: 2017-03-27
Last updated: 2026-07-14
Other registries' IDs: eudract:2016-004108-73
Results first posted: 2020-07-10

Source ClinicalTrials.gov

Registered outcomes6

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Progression Free Survival (PFS) by Blinded Independent Central Review (BICR)	RECIST tumour assessments every 6 weeks from randomisation until disease progression as defined by Recist 1.1 and confirmed by BICR.	Per Response Evaluation Criteria in Solid Tumours (RECIST v1.1) assessed by MRI or CT: Progressive Disease (PD): \>= 20% increase in the sum of diameters of TLs and an absolute increase in sum of diameters of \>=5mm (compared to the previous minimum sum) or progression of NTLs or a new lesion. PFS is the time from date of randomisation until the date of PD (defined by Recist 1.1 and confirmed by BICR) or death (by any cause in the absence of progression) regardless of whether the patient withdrew from randomised therapy or received another anti-cancer therapy prior to progression.
Secondary	Overall Survival (OS)	RECIST tumour assessments every 6 weeks from randomisation until disease progression as defined by Recist 1.1 and confirmed by BICR.	Time between the date of randomisation and the date of death due to any cause.
Secondary	Objective Response Rate (ORR) by BICR	RECIST tumour assessments every 6 weeks from randomisation until disease progression as defined by Recist 1.1 and confirmed by BICR.	Per Response Evaluation Criteria in Solid Tumours (RECIST v1.1) assessed by MRI or CT: Complete Response (CR): Disappearance of all target and non-target lesions and no new lesions; Partial Response (PR): \>= 30% decrease in the sum of diameters of Target Lesions (compared to baseline) and no new lesions. ORR is the percentage of patients with at least 1 visit response of CR or PR prior to progression or any further therapy.
Secondary	Duration of Response (DoR) by BICR	RECIST tumour assessments every 6 weeks from randomisation until disease progression as defined by Recist 1.1 and confirmed by BICR.	Per Response Evaluation Criteria in Solid Tumours (RECIST v1.1) assessed by MRI or CT: Complete Response (CR): Disappearance of all target and non-target lesions and no new lesions; Partial Response (PR): \>= 30% decrease in the sum of diameters of Target Lesions (compared to baseline) and no new lesions. DoR is the time from the date of first documented response until the date of documented progression or death in the absence of disease progression.
Secondary	Disease Control Rate (DCR) at 6 Months by BICR	RECIST tumour assessments every 6 weeks from randomisation until disease progression as defined by Recist 1.1 and confirmed by BICR.	Disease control rate at 6 months is defined as the percentage of patients who have a best objective response of Complete Response or Partial Response in that period or who have demonstrated Stable Disease for a minimum interval of 23 weeks.
Secondary	Disease Control Rate (DCR) at 12 Months by BICR	RECIST tumour assessments every 6 weeks from randomisation until disease progression as defined by Recist 1.1 and confirmed by BICR.	Disease control rate at 12 months is defined as the percentage of patients who have a best objective response of complete responses or partial responses in that period or who have demonstrated stable disease for a minimum interval of 47 weeks.

Source ClinicalTrials.gov

Outcomes6

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Progression Free Survival (PFS) by Blinded Independent Central Review (BICR)	RECIST tumour assessments every 6 weeks from randomisation until disease progression as defined by Recist 1.1 and confirmed by BICR.	Full Analysis Set (All randomised patients)	Months	MEDIAN
SECONDARY	Overall Survival (OS)	RECIST tumour assessments every 6 weeks from randomisation until disease progression as defined by Recist 1.1 and confirmed by BICR.	Full Analysis Set (All randomised patients)	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Objective Response Rate (ORR) by BICR	RECIST tumour assessments every 6 weeks from randomisation until disease progression as defined by Recist 1.1 and confirmed by BICR.	Full Analysis Set (All randomised patients)	% of participants	NUMBER
SECONDARY	Duration of Response (DoR) by BICR	RECIST tumour assessments every 6 weeks from randomisation until disease progression as defined by Recist 1.1 and confirmed by BICR.	Duration of Response (DoR) by BICR was calculated for all responders (N=11)	Months	MEDIAN
SECONDARY	Disease Control Rate (DCR) at 6 Months by BICR	RECIST tumour assessments every 6 weeks from randomisation until disease progression as defined by Recist 1.1 and confirmed by BICR.	Full Analysis Set (All randomised patients)	% of participants	NUMBER
SECONDARY	Disease Control Rate (DCR) at 12 Months by BICR	RECIST tumour assessments every 6 weeks from randomisation until disease progression as defined by Recist 1.1 and confirmed by BICR.	Full Analysis Set (All randomised patients)	% of participants	NUMBER

Source ClinicalTrials.gov

Results by group14

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Progression Free Survival (PFS) by Blinded Independent Central Review (BICR)	Savolitinib QD		7.0	95% Confidence Interval 2.8 to NA	Months
Progression Free Survival (PFS) by Blinded Independent Central Review (BICR)	Sunitinib QD		5.6	95% Confidence Interval 4.1 to 6.9	Months
Overall Survival (OS)	Savolitinib QD	Died	9		Participants
Overall Survival (OS)	Sunitinib QD	Died	13		Participants
Overall Survival (OS)	Savolitinib QD	Terminated study prior to death	24		Participants
Overall Survival (OS)	Sunitinib QD	Terminated study prior to death	14		Participants
Objective Response Rate (ORR) by BICR	Savolitinib QD		27.3	95% Confidence Interval 13.3 to 45.5	% of participants
Objective Response Rate (ORR) by BICR	Sunitinib QD		7.4	95% Confidence Interval 0.9 to 24.3	% of participants
Duration of Response (DoR) by BICR	Savolitinib QD		NA	95% Confidence Interval NA to NA	Months
Duration of Response (DoR) by BICR	Sunitinib QD		8.3	95% Confidence Interval NA to NA	Months

1 to 10 of 14Source ClinicalTrials.gov

See all 14 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Savolitinib QD	33
Overall Study	STARTED	Sunitinib QD	27
Overall Study	COMPLETED	Savolitinib QD	0
Overall Study	COMPLETED	Sunitinib QD	0
Overall Study	NOT COMPLETED	Savolitinib QD	33
Overall Study	NOT COMPLETED	Sunitinib QD	27

Source ClinicalTrials.gov

Adverse events164

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Conjuntivitis	Infections and infestations	Savolitinib QD	0	33	0
other	Conjuntivitis	Infections and infestations	Sunitinib QD	2	27	2
other	Urinary tract infection	Infections and infestations	Savolitinib QD	0	33	0
other	Urinary tract infection	Infections and infestations	Sunitinib QD	4	27	4
other	Anaemia	Blood and lymphatic system disorders	Savolitinib QD	2	33	2
other	Anaemia	Blood and lymphatic system disorders	Sunitinib QD	12	27	18
other	Leukopenia	Blood and lymphatic system disorders	Savolitinib QD	1	33	1
other	Leukopenia	Blood and lymphatic system disorders	Sunitinib QD	2	27	3
other	Neutropenia	Blood and lymphatic system disorders	Savolitinib QD	0	33	0
other	Neutropenia	Blood and lymphatic system disorders	Sunitinib QD	5	27	11

1 to 10 of 164Source ClinicalTrials.gov

See all 164 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Savolitinib QD	9	33
Total, all-cause mortality	Sunitinib QD	13	27
Total, other adverse events	Savolitinib QD	25	33
Total, other adverse events	Sunitinib QD	27	27
Total, serious adverse events	Savolitinib QD	8	33
Total, serious adverse events	Sunitinib QD	8	27

Source ClinicalTrials.gov

Papers2

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
32203306	DERIVED	PubMed
32469384	DERIVED	PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Savolitinib QD vs Sunitinib QD: deaths from any cause	Trial comparisons
Savolitinib QD vs Sunitinib QD: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT03091192

GET https://conductscience.org/api/trials/v1/NCT03091192/events?page=2

API reference For AI assistants