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

Completed · Phase 2

Conditions studied: Papillary Renal Cell Cancer

In brief

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.

Key facts

Study ID: NCT02127710
Run by: AstraZeneca
People needed: 111
Starts: 2014-04-30
Expected to finish: 2020-04-20
Last updated by the study team: 2021-04-19

Who can join

Age: 18 and older, up to 99. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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.
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.

You may not qualify if…

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.
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.

Where it is running

Research Site — Birmingham, Alabama, United States
Research Site — Duarte, California, United States
Research Site — Palo Alto, California, United States
Research Site — Fort Myers, Florida, United States
Research Site — Chicago, Illinois, United States
Research Site — Iowa City, Iowa, United States
Research Site — Boston, Massachusetts, United States
Research Site — Detroit, Michigan, United States
Research Site — New York, New York, United States
Research Site — Philadelphia, Pennsylvania, United States
Research Site — Nashville, Tennessee, United States
Research Site — Dallas, Texas, United States
Research Site — Houston, Texas, United States
Research Site — Calgary, Alberta, Canada
Research Site — Edmonton, Alberta, Canada
Research Site — Toronto, Ontario, Canada
Research Site — Toronto, Ontario, Canada
Research Site — Barcelona, Spain
Research Site — Cambridge, United Kingdom
Research Site — Glasgow, United Kingdom
Research Site — London, United Kingdom
Research Site — London, United Kingdom
Research Site — Manchester, United Kingdom

Full record on ClinicalTrials.gov

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