Trial · NCT02127710

A Phase II Trial to Evaluate the Efficacy of AZD6094 (HMPL-504) in Patients With Papillary Renal Cell Carcinoma (PRCC)

NCT02127710, Phase 2, Completed, AstraZeneca; results first posted 2017-10-12

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. A Phase II Trial to Evaluate the Efficacy of AZD6094 (HMPL-504) in Patients With Papillary Renal Cell Carcinoma (PRCC). Trials, record NCT02127710. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02127710

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Trial

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

Title: A Phase II Trial to Evaluate the Efficacy of AZD6094 (HMPL-504) in Patients With Papillary Renal Cell Carcinoma (PRCC)
NCT number: NCT02127710
Status: Completed
Phases: Phase 2
Enrollment: 111 participants, actual
Lead sponsor: AstraZeneca
Conditions: Papillary Renal Cell Cancer
Interventions: AZD6094
First posted: 2014-05-01
Last updated: 2021-04-19
Results first posted: 2017-10-12
Limitations and caveats: For the secondary outcome measure Duration of Response the median was not calculable because at data cut-off some participants were still responding.~Point to note: All patients on this trial received 600mg AZD6094 po.

Source ClinicalTrials.gov

Registered outcomes18

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

List	Outcome	Time frame	Description
Primary	Objective Response Rate (RECIST Version 1.1)	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.
Primary	Objective Response Rate (RECIST Version 1.1) Stratified by c-MET Status in Efficacy Analysis Set	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.
Primary	Objective Response Rate (RECIST Version 1.1) Stratified by c-MET Status in Safety Analysis Set	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.
Secondary	Progression Free Survival Stratified by c-MET Status in the Efficacy Analysis Set	Up to 12 months
Secondary	Overall Survival Stratified by c-MET Status in the Efficacy Analysis Set	Up to 12 months
Secondary	Progression Free Survival Stratified by c-MET Status in the Safety Analysis Set	Up to 12 months
Secondary	Overall Survival Stratified by c-MET Status in the Safety Analysis Set	Up to 12 months
Secondary	Change From Baseline in Target Lesion Tumour Size at 12 Weeks in Efficacy Analysis Set	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.
Secondary	Change From Baseline in Target Lesion Tumour Size at 12 Weeks in Safety Analysis Set.	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.
Secondary	Duration of Response	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.

1 to 10 of 18Source ClinicalTrials.gov

See all 18 registered outcomes

Outcomes18

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Objective Response Rate (RECIST Version 1.1)	Up to 12 months	ORR was assessed on the efficacy analysis set, consisting of all patients with measurable disease, PRCC confirmed by a central laboratory and have received at least 1 dose of AZD6094 (n = 85).	Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Objective Response Rate (RECIST Version 1.1) Stratified by c-MET Status in Efficacy Analysis Set	12 Months	ORR was assessed on the efficacy analysis set, consisting of all patients with measurable disease, PRCC confirmed by a central laboratory and received at least 1 dose of AZD6094 (n = 85).	Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Objective Response Rate (RECIST Version 1.1) Stratified by c-MET Status in Safety Analysis Set	12 Months	ORR was assessed on the safety analysis set, consisting of all patients who received at least one dose of the study drug (n = 109).	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Progression Free Survival Stratified by c-MET Status in the Efficacy Analysis Set	Up to 12 months		Weeks	MEDIAN
SECONDARY	Overall Survival Stratified by c-MET Status in the Efficacy Analysis Set	Up to 12 months		Weeks	MEDIAN
SECONDARY	Progression Free Survival Stratified by c-MET Status in the Safety Analysis Set	Up to 12 months		Weeks	MEDIAN
SECONDARY	Overall Survival Stratified by c-MET Status in the Safety Analysis Set	Up to 12 months		Weeks	MEDIAN
SECONDARY	Change From Baseline in Target Lesion Tumour Size at 12 Weeks in Efficacy Analysis Set	12 Weeks (at 12 weeks timepoint)		Percent change	MEAN
SECONDARY	Change From Baseline in Target Lesion Tumour Size at 12 Weeks in Safety Analysis Set.	12 Weeks (at 12 week timepoint)		Percent change	MEAN
SECONDARY	Duration of Response	Up to 12 months		Weeks	MEDIAN

1 to 10 of 18Source ClinicalTrials.gov

See all 18 outcomes

Results by group77

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

Outcome	Group	Category	Value	Units
Objective Response Rate (RECIST Version 1.1)	Efficacy Analysis Set	Complete Response	0	Participants
Objective Response Rate (RECIST Version 1.1)	Safety Analysis Set	Complete Response	0	Participants
Objective Response Rate (RECIST Version 1.1)	Efficacy Analysis Set	Partial Response	3	Participants
Objective Response Rate (RECIST Version 1.1)	Safety Analysis Set	Partial Response	8	Participants
Objective Response Rate (RECIST Version 1.1)	Efficacy Analysis Set	Stable Disease >= 5 Weeks	46	Participants
Objective Response Rate (RECIST Version 1.1)	Safety Analysis Set	Stable Disease >= 5 Weeks	59	Participants
Objective Response Rate (RECIST Version 1.1)	Efficacy Analysis Set	Progression	34	Participants
Objective Response Rate (RECIST Version 1.1)	Safety Analysis Set	Progression	40	Participants
Objective Response Rate (RECIST Version 1.1)	Efficacy Analysis Set	Not Evaluable	2	Participants
Objective Response Rate (RECIST Version 1.1)	Safety Analysis Set	Not Evaluable	2	Participants

1 to 10 of 77Source ClinicalTrials.gov

See all 77 results by group

Participant flow9

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

Period	Milestone	Group	Participants
Overall Study	STARTED	c-MET Positive [600mg AZD6094 po]	46
Overall Study	STARTED	c-MET Negative [600mg AZD6094 po]	47
Overall Study	STARTED	c-MET Status Unknown [600mg AZD6094 po]	16
Overall Study	COMPLETED	c-MET Positive [600mg AZD6094 po]	46
Overall Study	COMPLETED	c-MET Negative [600mg AZD6094 po]	47
Overall Study	COMPLETED	c-MET Status Unknown [600mg AZD6094 po]	16
Overall Study	NOT COMPLETED	c-MET Positive [600mg AZD6094 po]	0
Overall Study	NOT COMPLETED	c-MET Negative [600mg AZD6094 po]	0
Overall Study	NOT COMPLETED	c-MET Status Unknown [600mg AZD6094 po]	0

Source ClinicalTrials.gov

Adverse events88

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
other	Anaemia	Blood and lymphatic system disorders	AZD6094 600 mg Per Day Orally	17	109
other	Nausea	Gastrointestinal disorders	AZD6094 600 mg Per Day Orally	56	109
other	Vomiting	Gastrointestinal disorders	AZD6094 600 mg Per Day Orally	34	109
other	Constipation	Gastrointestinal disorders	AZD6094 600 mg Per Day Orally	29	109
other	Diarrhoea	Gastrointestinal disorders	AZD6094 600 mg Per Day Orally	18	109
other	Abdominal pain	Gastrointestinal disorders	AZD6094 600 mg Per Day Orally	9	109
other	Abdominal distension	Gastrointestinal disorders	AZD6094 600 mg Per Day Orally	6	109
other	Stomatitis	Gastrointestinal disorders	AZD6094 600 mg Per Day Orally	6	109
other	Fatigue	General disorders	AZD6094 600 mg Per Day Orally	49	109
other	Peripheral oedema	General disorders	AZD6094 600 mg Per Day Orally	35	109

1 to 10 of 88Source ClinicalTrials.gov

See all 88 adverse events

Adverse event totals3

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	AZD6094 600 mg Per Day Orally	57	109
Total, other adverse events	AZD6094 600 mg Per Day Orally	107	109
Total, serious adverse events	AZD6094 600 mg Per Day Orally	27	109

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

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 comparisons0

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

None in this release.

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/NCT02127710

GET https://conductscience.org/api/trials/v1/NCT02127710/results?page=2

API reference For AI assistants