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

NCT02127710 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 111

Last updated 2021-04-19

Study results available
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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.

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.

Conditions

  • Papillary Renal Cell Cancer

Interventions

DRUG

AZD6094

AZD6094 is a potent and selective small molecule mesenchymal epithelial transition (c-MET) kinase inhibitor.

Sponsors & Collaborators

  • SCRI Development Innovations, LLC

    collaborator OTHER

  • AstraZeneca

    lead INDUSTRY

Principal Investigators

  • Henrik-Tobias Arkenau, MD,PhD · Sarah Cannon Research Institute United Kingdom

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-04-30
Primary Completion
2016-04-14
Completion
2020-04-20

Countries

  • United States
  • Canada
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02127710 on ClinicalTrials.gov