Adults 18 to 99, any sex, with Papillary Renal Cell Cancer. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Objective Response Rate (RECIST Version 1.1)Primary· Up to 12 months
The primary outcome measure was Objective Response Rate (ORR), defined as the proportion of patients with either a complete response or a partial response by investigator assessment according to Response Evaluation Criteria for Solid Tumours (RECIST) v1.1.
Group
Value
95% CI
Efficacy Analysis Set
0
Safety Analysis Set
0
Efficacy Analysis Set
3
Safety Analysis Set
8
Efficacy Analysis Set
46
Safety Analysis Set
59
Efficacy Analysis Set
34
Safety Analysis Set
40
Objective Response Rate (RECIST Version 1.1) Stratified by c-MET Status in Efficacy Analysis SetPrimary· 12 Months
The primary outcome measure was ORR, defined as the proportion of patients with either a complete response or a partial response by investigator assessment according to RECIST v1.1.
Group
Value
95% CI
c-MET Positive [600mg AZD6094 po]
0
c-MET Negative [600mg AZD6094 po]
0
c-MET Status Unknown [600mg AZD6094 po]
0
Total [600mg AZD6094 po]
0
c-MET Positive [600mg AZD6094 po]
3
c-MET Negative [600mg AZD6094 po]
0
c-MET Status Unknown [600mg AZD6094 po]
0
Total [600mg AZD6094 po]
3
c-MET Positive [600mg AZD6094 po]
23
c-MET Negative [600mg AZD6094 po]
19
c-MET Status Unknown [600mg AZD6094 po]
4
Total [600mg AZD6094 po]
46
c-MET Positive [600mg AZD6094 po]
10
c-MET Negative [600mg AZD6094 po]
20
c-MET Status Unknown [600mg AZD6094 po]
4
Total [600mg AZD6094 po]
34
Objective Response Rate (RECIST Version 1.1) Stratified by c-MET Status in Safety Analysis SetPrimary· 12 Months
The primary outcome measure was ORR, defined as the proportion of patients with either a confirmed complete response/partial response by investigator assessment according to RECIST v1.1.
Group
Value
95% CI
c-MET Positive [600mg AZD6094 po]
0
c-MET Negative [600mg AZD6094 po]
0
c-MET Status Unknown [600mg AZD6094 po]
0
Total [600mg AZD6094 po]
0
c-MET Positive [600mg AZD6094 po]
8
c-MET Negative [600mg AZD6094 po]
0
c-MET Status Unknown [600mg AZD6094 po]
0
Total [600mg AZD6094 po]
8
c-MET Positive [600mg AZD6094 po]
27
c-MET Negative [600mg AZD6094 po]
21
c-MET Status Unknown [600mg AZD6094 po]
11
Total [600mg AZD6094 po]
59
c-MET Positive [600mg AZD6094 po]
10
c-MET Negative [600mg AZD6094 po]
25
c-MET Status Unknown [600mg AZD6094 po]
5
Total [600mg AZD6094 po]
40
Progression Free Survival Stratified by c-MET Status in the Efficacy Analysis SetSecondary· Up to 12 months
Group
Value
95% CI
c-MET Positive [600mg AZD6094 po]
18.3
12.3 – 35.4
c-MET Negative [600mg AZD6094 po]
9.7
6.1 – 12.4
c-MET Status Unknown [600mg AZD6094 po]
6.1
5.1 – NA
Overall Survival Stratified by c-MET Status in the Efficacy Analysis SetSecondary· Up to 12 months
Group
Value
95% CI
c-MET Positive [600mg AZD6094 po]
NA
34.6 – NA
c-MET Negative [600mg AZD6094 po]
61.1
29.4 – NA
c-MET Status Unknown [600mg AZD6094 po]
51.5
8.1 – NA
Progression Free Survival Stratified by c-MET Status in the Safety Analysis SetSecondary· Up to 12 months
Group
Value
95% CI
c-MET Positive [600mg AZD6094 po]
24.7
17.7 – 35.4
c-MET Negative [600mg AZD6094 po]
6.6
6.1 – 11.9
c-MET Status Unknown [600mg AZD6094 po]
12.1
6.1 – 41.9
Overall Survival Stratified by c-MET Status in the Safety Analysis SetSecondary· Up to 12 months
Group
Value
95% CI
c-MET Positive [600mg AZD6094 po]
NA
42.9 – NA
c-MET Negative [600mg AZD6094 po]
61.1
40.6 – 106.7
c-MET Status Unknown [600mg AZD6094 po]
54.9
18.4 – NA
Change From Baseline in Target Lesion Tumour Size at 12 Weeks in Efficacy Analysis SetSecondary· 12 Weeks (at 12 weeks timepoint)
12 week summary for patients in the Efficacy analysis set, by MET status. The numbers of patients analysed represent the numbers evaluable at the 12 week timepoint.
Group
Value
95% CI
c-MET Positive [600mg AZD6094 po]
-6.3
± 21.56
c-MET Negative [600mg AZD6094 po]
3.4
± 20.05
c-MET Status Unknown [600mg AZD6094 po]
7.1
± 0
Change From Baseline in Target Lesion Tumour Size at 12 Weeks in Safety Analysis Set.Secondary· 12 Weeks (at 12 week timepoint)
12 week summary for patients in the Safety analysis set by MET Status. The number of patients analysed represent the number of evaluable patients at the 12 week timepoint.
Group
Value
95% CI
c-MET Positive [600mg AZD6094 po]
-10.9
± 21.39
c-MET Negative [600mg AZD6094 po]
4.3
± 18.96
c-MET Status Unknown [600mg AZD6094 po]
5.1
± 17.41
Duration of ResponseSecondary· Up to 12 months
Duration of Response is the time from the first documentation of confirmed complete response/partial response until the date of progression, or death in the absence of progression. There were 8 responders: one of whom subsequently progressed or died and seven of whom were still classified as responders at the time of data cut-off and were therefore censored. It was not possible to determine a median or 75th percentile.
Group
Value
95% CI
Safety Analysis Set [600mg AZD6094 po]
NA
18.1 – NA
Peak Plasma Concentration of AZD6094 Following Single DoseSecondary· 24 Hours
The number of patients analysed represent the number of patients with evaluable PK parameters for this endpoint.
Group
Value
95% CI
Pharmacokinetic Analysis Set [600mg AZD6094 po]
3038.8984
± 44.4184
Time to Peak Plasma Concentration of AZD6094 After Single DoseSecondary· 24 Hours
The number of patients analysed represent the number of patients with evaluable PK parameters for this endpoint.
Group
Value
95% CI
Pharmacokinetic Analysis Set [600mg AZD6094 po]
2.0
0.5 – 8.0
Adverse events — posted to ClinicalTrials.gov
Time frame: Up to 12 months.
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
This is an open-label, single-arm, multicentre, global, phase II study designed to evaluate the efficacy and safety of AZD6094 in patients with papillary renal cell carcinoma (PRCC) who are treatment naïve or previously treated.
An independent central pathology review of tumour samples will be used to confirm the diagnosis of PRCC of all patients enrolling. However, locally available pathology results confirming PRCC will be allowed for timely study entry.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT02447380 — Study of AZD6094 (Volitinib) in Combination With Docetaxel, in Advanced Gastric Adenocarcinoma Patients With MET Overexp
· Phase 2
· completed
NCT02447406 — Phase Ib, Single-arm Study of AZD6094 (Volitinib) in Combination With Docetaxel, in Any Solid Cancer and Sequential Phas
· Phase 1, PHASE2
· completed
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by AstraZeneca
Last refreshed: 19 April 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02127710.