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Osimertinib; AZD9291

Phase 1

Solid Tumours | Small molecule | Oncology |AstraZeneca PLC|Last Updated: Nov 27, 2023

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
CONTROLLEDBiomarker
Total Trials1
Total Enrollment16
FDA Designations
PRIORITY_REVIEW
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02923947Study to Assess Osimertinib in Patients w/ Adv Solid Tumours & Normal Kidney Function or Severe Kidney ImpairmentPHASE1 COMPLETED 16 — — May 4, 2017Oct 28, 2022Nov 27, 202311 France, South Korea +1
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Study Endpoints
Primary Endpoints
Area under the plasma concentration-time curve from zero to infinity for osimertinib
On Day of dosing in Part A - predose, 1, 2, 4, 6, 8, 10, 24, 48, 72, 120, 168, 216hrs post-dose

Part A: To investigate the PK of osimertinib after a single oral dose of 80 mg in patients with advanced solid tumours and normal renal function or severe renal impairment.

Maximum plasma concentration for osimertinib
On Day of dosing in Part A - predose, 1, 2, 4, 6, 8, 10, 24, 48, 72, 120, 168, 216hrs post-dose

Part A: To investigate the PK of osimertinib after a single oral dose of 80 mg in patients with advanced solid tumours and normal renal function or severe renal impairment.

Secondary Endpoints
Area under the plasma concentration-time curve from zero to the last quantifiable time point for osimertinib
On Day of dosing in Part A - predose, 1, 2, 4, 6, 8, 10, 24, 48, 72, 120, 168, 216hrs for osimertinib post-dose
Area under the plasma concentration-time curve from zero to 24 hours post-dose for osimertinib
On Day of dosing in Part A - predose, 1, 2, 4, 6, 8, 10, 24hrs for osimertinib post-dose
Time to maximum plasma concentration for osimertinib
On Day of dosing in Part A - predose, 1, 2, 4, 6, 8, 10, 24, 48, 72, 120, 168, 216hrs for osimertinib post-dose
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Normal renal functionEXPERIMENTALFor inclusion in the study as a patient with normal renal function, patients must have creatinine clearance ≥90 mL/min.
Severe renal impairmentEXPERIMENTALFor inclusion in the study as a patient with severe renal impairment, patients must have stable severe renal impairment (creatinine clearance \<30 mL/min), as defined by the Cockcroft Gault equation, for at least 2 months prior to Day 1.
Interventions
NameTypeDescription
Osimertinib; AZD9291DRUG80mg tablet dose to be taken orally - single dose in part A, daily dosing in Part B and continued access until progression or no longer receiving benefit
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Eligibility Criteria
Age Range18 Years — 130 Years
SexALL
Healthy VolunteersNo
Study Sites11

Inclusion criteria: 1. For inclusion as a patient with severe renal impairment patient must have stable severe renal impairment (CrCl \<30 mL/min at screening), for at least 2 months prior to the study. 2. For inclusion as a patient with normal renal function, patient must have CrCl ≥90 mL/min at s...

Countries:FranceSouth KoreaSpain
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Competitive Landscape -Other Solid Tumors 9 trials
CompanyTickerTrialsLead PhaseDrugs
Merck & Co., Inc.MRK2PHASE2pembrolizumab, V503, GARDASIL
Incyte CorporationINCY1PHASE2Chemotherapy, Retifanlimab
Novartis AG Sponsored ADRNVS1PHASE1KFA115, pembrolizumab
Iovance Biotherapeutics IncIOVA2PHASE2E7 TCR-T cells, Aldesleukin
AstraZeneca PLCAZN1 — Trastuzumab deruxtecan
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