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AZD6094

Phase 2

Papillary Renal Cell Cancer | Small molecule | Oncology |AstraZeneca PLC|Last Updated: Apr 19, 2021

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment111
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02127710A Phase II Trial to Evaluate the Efficacy of AZD6094 (HMPL-504) in Patients With Papillary Renal Cell Carcinoma (PRCC)PHASE2 COMPLETED 111Apr 30, 2014Apr 20, 2020Apr 19, 202123 United States, Canada +2
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Study Endpoints
Primary Endpoints
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.

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.

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 Endpoints
Progression Free Survival Stratified by c-MET Status in the Efficacy Analysis Set
Up to 12 months
Overall Survival Stratified by c-MET Status in the Efficacy Analysis Set
Up to 12 months
Progression Free Survival Stratified by c-MET Status in the Safety Analysis Set
Up to 12 months
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
AZD6094 600 mg daily continuouslyEXPERIMENTALAll patients entering the study will take AZD6094 600 mg by mouth (PO) once daily (QD). Treatment will be given continuously.
Interventions
NameTypeDescription
AZD6094DRUGAZD6094 is a potent and selective small molecule mesenchymal epithelial transition (c-MET) kinase inhibitor.
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Eligibility Criteria
Age Range18 Years — 99 Years
SexALL
Healthy VolunteersNo
Study Sites23

Inclusion criteria 1. Provision of informed consent prior to any study specific procedures, sampling and analyses. 2. Histologically confirmed PRCC, which is locally advanced or metastatic. 3. Availability of an archival tumor sample or a pre-treatment fresh tumor sample for confirmation of PRCC by...

Countries:United StatesCanadaSpainUnited Kingdom
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