Papillary Renal Cell CancerPhase 2NCT02127710
A Phase II Trial to Evaluate the Efficacy of AZD6094 (HMPL-504) in Patients With Papillary Renal Cell Carcinoma (PRCC)
A Phase 2 study testing AZD6094 in people with Papillary Renal Cell Cancer, run by AstraZeneca at 23 sites in 4 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Papillary Renal Cell Cancer
- What is being tested?
- AZD6094
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 111 participants
- Where
- 23 sitesin 4 countries
- Study dates
- 30 Apr 2014to 20 Apr 2020
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Provision of informed consent prior to any study specific procedures, sampling and analyses.
- Histologically confirmed PRCC, which is locally advanced or metastatic.
- Availability of an archival tumor sample or a pre-treatment fresh tumor sample for confirmation of PRCC by a central laboratory and other biomarker
- Treatment naïve or have failed on previous treatment for PRCC. Previous treatments may include: targeted therapy (i.e. sunitinib, sorafenib, bevacizumab, pazopanib, temsirolimus, and everolimus), traditional immunotherapy (i.e. interferon-a, Interleukin-2), chemotherapy or a combination of chemoimmunotherapy.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- At least one lesion, not previously irradiated, and not chosen for a biopsy if performed during the screening period that can be accurately measured at baseline and which is suitable for accurate repeated measurements.
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- Adequate hematological function defined as:
- Absolute neutrophil count ≥1500/μL
- Haemoglobin ≥9 g/dL
- Platelets ≥100,000/μL
- Adequate liver function defined as:
- Alanine aminotransferase and aspartate aminotransferase ≤2.5 x the upper limit of normal (ULN)
- Total bilirubin ≤1.5 x ULN
- Adequate renal function defined as glomerular filtration rate ≥ 40 mL/min,
- Adequate coagulation parameters, defined as International Normalisation Ratio <1.5 x ULN or activated partial thromboplastin time <1.5 x ULN.
- Patients with known tumor thrombus or deep vein thrombosis are eligible if stable on low molecular weight heparin for ≥4 weeks.
- Females should be using adequate contraceptive measures should not be breast feeding, and must have a negative pregnancy test prior to start of dosing if of childbearing potential or must have evidence of non-childbearing potential
- Male patients should be willing to use barrier contraception, i.e. condoms.
- Ability to swallow and retain oral medications.
- Predicted life expectancy ≥12 weeks.
- Aged at least 18 years.
- Willingness and ability to comply with study and follow-up procedures.
- Ability to understand the nature of this study and give written informed consent.
Who cannot join
- Most recent chemotherapy, immunotherapy, chemo-immunotherapy, or investigational agents <21 days of the first dose of study treatment. Most recent targeted therapy <14 days of the first dose of study treatment.
- Unresolved toxicities from any prior therapy greater than Common Terminology Criteria for Adverse Events Grade 1 at the time of starting study treatment with the exception of alopecia.
- Prior or current treatment with a cMet inhibitor
- Strong inducers or inhibitors of cytochrome P450 3A4 (CYP3A4), strong inhibitors of cytochrome P450 1A2 (CYP1A2), or CYP3A4 substrates with a narrow therapeutic range within 2 weeks before the first dose of study treatment (3 weeks for St John's Wort)
- Wide field radiotherapy (including therapeutic radioisotopes such as strontium-89) administered ≤28 days or limited field radiation for palliation ≤7 days prior to starting study drug or has not recovered from side effects of such therapy
- Major surgical procedures ≤28 days of beginning study drug or minor surgical procedures ≤7 days. No waiting is required following port-a-cath placement.
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- Previously untreated brain metastases.
- Current leptomeningeal metastases or spinal cord compression due to disease.
- Acute or chronic liver or pancreatic disease.
- Uncontrolled diabetes mellitus.
- Gastrointestinal disease or other condition that will interfere significantly with the absorption, distribution, metabolism, or excretion of oral therapy
- Any of the following cardiac diseases currently or within the last 6 months:
- Unstable angina pectoris
- Congestive heart failure (New York Heart Association ≥ Grade 2)
- Acute myocardial infarction
- Stroke or transient ischemic attack
- Inadequately controlled hypertension (i.e., systolic blood pressure >160 mmHg or diastolic blood pressure >100 mmHg) (patients with values above these levels must have their blood pressure controlled with medication prior to starting treatment).
- Mean resting correct QT interval (QTc) >470 msec obtained from triplicate electrocardiagrams
- Any clinically important abnormalities in rhythm, conduction or morphology of resting electrocardiograms, e.g. complete left bundle branch block, third degree heart block, second degree heart block, PR interval >250 msec.
- Any factors that increase the risk of QTc prolongation or risk of arrhythmic events such as heart failure, hypokalaemia, congenital or familial long QT syndrome or family history of unexplained sudden death under 40 years of age or any concomitant medications known to prolong QT interval.
- Currently receiving treatment with therapeutic doses of warfarin sodium. Low molecular weight heparin is allowed.
- Serious active infection at the time of treatment, or another serious underlying medical condition that would impair the ability of the patient to receive protocol treatment.
- Known diagnosis of human immunodeficiency virus, hepatitis B, or hepatitis C.
- Presence of other active cancers, or history of treatment for invasive cancer ≤5years. Patients with Stage I cancer who have received definitive local treatment at least 3 years previously, and are considered unlikely to recur are eligible. All patients with previously treated in situ carcinoma (i.e., non-invasive) are eligible, as are patients with history of non-melanoma skin cancer.
- Psychological, familial, sociological, or geographical conditions that do not permit compliance with the protocol.
Trial locations and contacts
23 sites in 4 countries.
23 sites in 4 countries
United States13 sites
Research Site
Birmingham, Alabama, 35294
Research Site
Boston, Massachusetts, 02215
Research Site
Chicago, Illinois, 60637
Research Site
Dallas, Texas, 75246
Research Site
Detroit, Michigan, 48201
Research Site
Duarte, California, 91010
Research Site
Fort Myers, Florida, 33916
Research Site
Houston, Texas, 77030
Research Site
Iowa City, Iowa, 52242
Research Site
Nashville, Tennessee, 37203
Research Site
New York, New York, 10021
Research Site
Palo Alto, California, 94305
Research Site
Philadelphia, Pennsylvania, 19111
United Kingdom5 sites
Research Site
Cambridge, CB2 0QQ
Research Site
Glasgow, G12 OYN
Research Site
London, EC1M 6BQ
Research Site
London, W1G 6AD
Research Site
Manchester, M20 4BX
Canada4 sites
Research Site
Calgary, Alberta, T2N 4N2
Research Site
Edmonton, Alberta, T6G 1Z2
Research Site
Toronto, Ontario, M4N 3M5
Research Site
Toronto, Ontario, M5G 2M9
About this study
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.
Read the detailed description
The study will comprise two stages. In Stage 1 approximately 20 patients will be enrolled. This group is considered sufficient to provide preliminary assessment of the anti-tumour activity of AZD6094 in the form of non-binding futility analysis.
If ≤ 2 tumour responses are observed in the first 20 evaluable patients termination of the study will be considered taking into account the relevant molecular profile of the patients and additional information from related studies in the drug development programme.
All patients entering the study will take AZD6094 600 mg by mouth (PO) once daily (QD). Treatment will be given continuously.
Following the baseline assessment, efficacy will be assessed by objective tumour assessments every 6 weeks (±7 days), for the first 12 months and every 12 weeks thereafter until objective disease progression as defined by RECIST v1.1 There will be a data cut-off after all patients have completed at least 12 weeks of treatment with AZD6094 or withdrawn. The database will be locked and data analysis will be performed on this dataset.
Any patients still receiving study drug at the time of data cut-off will be able to continue to receive AZD6094 while deriving clinical benefit. Such patients will continue to be monitored for the occurrence of serious adverse events up to 28 days after the last dose of AZD6094.
After database lock (DBL) tumour assessments will be performed every 12 weeks (±7 days) until objective disease progression as defined by RECIST v1.1.
Patients discontinuing treatment due to documented disease progression will enter a survival follow-up period, where they will be followed for the initiation of subsequent anti-cancer therapies every 3 months until death, loss to follow-up or withdrawal of consent, whichever comes first.
Patients discontinuing treatment prior to documented disease progression will enter a progression-free survival follow-up period where they will continue to have disease assessments every 6 weeks (±7 days) for the first 12 months of follow-up and every 12 weeks thereafter until objective disease progression as defined by RECIST v1.1, death, loss to follow-up or withdrawal of consent, whichever comes first. After DBL, tumour assessments will be performed in the progression free survival patient population every 12 weeks (±7 days) until objective disease progression as defined by RECIST v1.1
- Conditions
- Papillary Renal Cell Cancer
- Being tested
- AZD6094
- Keywords
- AZD6094, Savolitinib, Papillary Renal Cell Cancer
- Medical subject headings
- Carcinoma, Renal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AZD6094Drug
Also called Savolitinib, HMPL - 504
AZD6094 is a potent and selective small molecule mesenchymal epithelial transition (c-MET) kinase inhibitor.
| Study group | Role | What they receive |
|---|---|---|
| AZD6094 600 mg daily continuously | Experimental | All patients entering the study will take AZD6094 600 mg by mouth (PO) once daily (QD). Treatment will be given continuously. Receives: Drug: AZD6094 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate (RECIST Version 1.1)
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.
Measured: Up to 12 months
Objective Response Rate (RECIST Version 1.1) Stratified by c-MET Status in Efficacy Analysis Set
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.
Measured: 12 Months
Objective Response Rate (RECIST Version 1.1) Stratified by c-MET Status in Safety Analysis Set
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.
Measured: 12 Months
Secondary outcomes (15)
Progression Free Survival Stratified by c-MET Status in the Efficacy Analysis Set
Measured: Up to 12 months
Overall Survival Stratified by c-MET Status in the Efficacy Analysis Set
Measured: Up to 12 months
Progression Free Survival Stratified by c-MET Status in the Safety Analysis Set
Measured: Up to 12 months
Overall Survival Stratified by c-MET Status in the Safety Analysis Set
Measured: Up to 12 months
Change From Baseline in Target Lesion Tumour Size at 12 Weeks in Efficacy Analysis Set
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.
Measured: 12 Weeks (at 12 weeks timepoint)
Change From Baseline in Target Lesion Tumour Size at 12 Weeks in Safety Analysis Set.
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.
Measured: 12 Weeks (at 12 week timepoint)
Duration of Response
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.
Measured: Up to 12 months
Peak Plasma Concentration of AZD6094 Following Single Dose
The number of patients analysed represent the number of patients with evaluable PK parameters for this endpoint.
Measured: 24 Hours
Time to Peak Plasma Concentration of AZD6094 After Single Dose
The number of patients analysed represent the number of patients with evaluable PK parameters for this endpoint.
Measured: 24 Hours
Apparent Volume of Distribution of AZD6094 Following Single Dose
The number of patients analysed represent the number of patients with evaluable PK parameters for this endpoint.
Measured: 24 Hours
Area Under Plasma Concentration Time Curve for AZD6094 After Single Dose
The number of patients analysed represent the number of patients with evaluable PK parameters for this endpoint.
Measured: 24 Hours
Area Under Plasma Concentration Time Curve for AZD6094 After Single Dose (Time Zero to Last Measurement)
The number of patients analysed represent the number of patients with evaluable PK parameters for this endpoint.
Measured: 24 Hours
Apparent Total Clearance of AZD6094 From Plasma After Single Dose
The number of patients analysed represent the number of patients with evaluable PK parameters for this endpoint.
Measured: 24 Hours
Mean Residence Time of AZD6094 After Single Dose
The number of patients analysed represent the number of evaluable PK parameters for this endpoint.
Measured: 24 Hours
Elimination Half-Life of AZD6094 After Single Dose
The number of patients analysed represent the number of patients with evaluable PK parameters for this endpoint.
Measured: 24 Hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2014 (estimated)
- Study start30 Apr 2014
- Primary completion14 Apr 2016
- Study completion20 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Papillary Renal Cell CancerStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 111 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- SCRI Development Innovations, LLC
- Responsible party
- Sponsor
- Investigators
- Henrik-Tobias Arkenau, MD,PhD, Study chair, Sarah Cannon Research Institute United Kingdom
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02127710
- Sponsor's protocol ID
- D5082C00002
- Other IDs
- GU 111
- Status last verified
- Mar 2021
- First submitted
- 23 Apr 2014
- Last updated
- 19 Apr 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Trial to Evaluate the Efficacy of AZD6094 (HMPL-504) in Patients With Papillary Renal Cell Carcinoma (PRCC)
- ClinicalTrials.gov ID
- NCT02127710
- Acronym / sponsor ID
- D5082C00002
- Conditions
- Papillary Renal Cell Cancer
- Keywords
- AZD6094, Savolitinib, Papillary Renal Cell Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 111 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Collaborators
- SCRI Development Innovations, LLC
- Study start
- 30 Apr 2014 (actual)
- Primary completion
- 14 Apr 2016 (actual)
- Study completion
- 20 Apr 2020 (actual)
- First posted
- 1 May 2014 (estimated)
- Results
- Posted 12 Oct 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The study will comprise two stages. In Stage 1 approximately 20 patients will be enrolled. This group is considered sufficient to provide preliminary assessment of the anti-tumour activity of AZD6094 in the form of non-binding futility analysis.
If ≤ 2 tumour responses are observed in the first 20 evaluable patients termination of the study will be considered taking into account the relevant molecular profile of the patients and additional information from related studies in the drug development programme.
All patients entering the study will take AZD6094 600 mg by mouth (PO) once daily (QD). Treatment will be given continuously.
Following the baseline assessment, efficacy will be assessed by objective tumour assessments every 6 weeks (±7 days), for the first 12 months and every 12 weeks thereafter until objective disease progression as defined by RECIST v1.1 There will be a data cut-off after all patients have completed at least 12 weeks of treatment with AZD6094 or withdrawn. The database will be locked and data analysis will be performed on this dataset.
Any patients still receiving study drug at the time of data cut-off will be able to continue to receive AZD6094 while deriving clinical benefit. Such patients will continue to be monitored for the occurrence of serious adverse events up to 28 days after the last dose of AZD6094.
After database lock (DBL) tumour assessments will be performed every 12 weeks (±7 days) until objective disease progression as defined by RECIST v1.1.
Patients discontinuing treatment due to documented disease progression will enter a survival follow-up period, where they will be followed for the initiation of subsequent anti-cancer therapies every 3 months until death, loss to follow-up or withdrawal of consent, whichever comes first.
Patients discontinuing treatment prior to documented disease progression will enter a progression-free survival follow-up period where they will continue to have disease assessments every 6 weeks (±7 days) for the first 12 months of follow-up and every 12 weeks thereafter until objective disease progression as defined by RECIST v1.1, death, loss to follow-up or withdrawal of consent, whichever comes first. After DBL, tumour assessments will be performed in the progression free survival patient population every 12 weeks (±7 days) until objective disease progression as defined by RECIST v1.1
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AZD6094 600 mg daily continuously | Experimental | Drug: AZD6094All patients entering the study will take AZD6094 600 mg by mouth (PO) once daily (QD). Treatment will be given continuously. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (23 listed)
- Provision of informed consent prior to any study specific procedures, sampling and analyses.
- Histologically confirmed PRCC, which is locally advanced or metastatic.
- Availability of an archival tumor sample or a pre-treatment fresh tumor sample for confirmation of PRCC by a central laboratory and other biomarker
- Treatment naïve or have failed on previous treatment for PRCC. Previous treatments may include: targeted therapy (i.e. sunitinib, sorafenib, bevacizumab, pazopanib, temsirolimus, and everolimus), traditional immunotherapy (i.e. interferon-a, Interleukin-2), chemotherapy or a combination of chemoimmunotherapy.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Key exclusion criteria (25 listed)
- Most recent chemotherapy, immunotherapy, chemo-immunotherapy, or investigational agents <21 days of the first dose of study treatment. Most recent targeted therapy <14 days of the first dose of study treatment.
- Unresolved toxicities from any prior therapy greater than Common Terminology Criteria for Adverse Events Grade 1 at the time of starting study treatment with the exception of alopecia.
- Prior or current treatment with a cMet inhibitor
- Strong inducers or inhibitors of cytochrome P450 3A4 (CYP3A4), strong inhibitors of cytochrome P450 1A2 (CYP1A2), or CYP3A4 substrates with a narrow therapeutic range within 2 weeks before the first dose of study treatment (3 weeks for St John's Wort)
- Wide field radiotherapy (including therapeutic radioisotopes such as strontium-89) administered ≤28 days or limited field radiation for palliation ≤7 days prior to starting study drug or has not recovered from side effects of such therapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AZD6094Also: Savolitinib, HMPL - 504AZD6094 is a potent and selective small molecule mesenchymal epithelial transition (c-MET) kinase inhibitor. | Drug | AZD6094 600 mg daily continuously |
Primary outcome
Objective Response Rate (RECIST Version 1.1)
Time frame: 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.
Objective Response Rate (RECIST Version 1.1) Stratified by c-MET Status in Efficacy Analysis Set
Time frame: 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.
Objective Response Rate (RECIST Version 1.1) Stratified by c-MET Status in Safety Analysis Set
Time frame: 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.
15 secondary outcomes
Progression Free Survival Stratified by c-MET Status in the Efficacy Analysis Set
Time frame: Up to 12 months
Overall Survival Stratified by c-MET Status in the Efficacy Analysis Set
Time frame: Up to 12 months
Progression Free Survival Stratified by c-MET Status in the Safety Analysis Set
Time frame: Up to 12 months
Overall Survival Stratified by c-MET Status in the Safety Analysis Set
Time frame: Up to 12 months
Change From Baseline in Target Lesion Tumour Size at 12 Weeks in Efficacy Analysis Set
Time frame: 12 Weeks (at 12 weeks timepoint)
Change From Baseline in Target Lesion Tumour Size at 12 Weeks in Safety Analysis Set.
Time frame: 12 Weeks (at 12 week timepoint)
Duration of Response
Time frame: Up to 12 months
Peak Plasma Concentration of AZD6094 Following Single Dose
Time frame: 24 Hours
Time to Peak Plasma Concentration of AZD6094 After Single Dose
Time frame: 24 Hours
Apparent Volume of Distribution of AZD6094 Following Single Dose
Time frame: 24 Hours
Area Under Plasma Concentration Time Curve for AZD6094 After Single Dose
Time frame: 24 Hours
Area Under Plasma Concentration Time Curve for AZD6094 After Single Dose (Time Zero to Last Measurement)
Time frame: 24 Hours
Apparent Total Clearance of AZD6094 From Plasma After Single Dose
Time frame: 24 Hours
Mean Residence Time of AZD6094 After Single Dose
Time frame: 24 Hours
Elimination Half-Life of AZD6094 After Single Dose
Time frame: 24 Hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- D5082c00002-revised-csp-3\_RedactedLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Henrik-Tobias Arkenau, MD,PhD study chair
Sarah Cannon Research Institute United Kingdom
23 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing AZD6094 in people with Papillary Renal Cell Cancer, run by AstraZeneca at 23 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 23 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 sites in United States, United Kingdom, Canada, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Oct 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate (RECIST Version 1.1) (time frame: Up to 12 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2021.