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Osimertinib; AZD9291

Phase 1

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

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials1
Total Enrollment16

FDA Designations

PRIORITY_REVIEW

Clinical trial landscape

Osimertinib; AZD9291 · 1 trial · 1 indication

Phase 1 1
NCT02923947Study to Assess Osimertinib in Patients w/ Adv Solid Tumours & Normal Kidney Function or Severe Kidney ImpairmentSolid Tumours
COMPLETED16 Analytics
PHASE1COMPLETED
Study to Assess Osimertinib in Patients w/ Adv Solid Tumours & Normal Kidney Function or Severe Kidney Impairment
Solid Tumours
NCT0292394716
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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 to 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 (matched to "Solid Tumours")

CompanyTickerTrialsLead PhaseDrugs
Merck & Co., Inc.MRK2PHASE2pembrolizumab
Incyte CorporationINCY1PHASE2Chemotherapy, Retifanlimab
Iovance Biotherapeutics IncIOVA2PHASE2E7 TCR-T cells, Aldesleukin
Novartis AG Sponsored ADRNVS1PHASE1KFA115, pembrolizumab
AstraZeneca PLCAZN1 - Trastuzumab deruxtecan
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Frequently asked questions about Osimertinib; AZD9291

What is Osimertinib used for?

Osimertinib, also known as AZD9291, is an investigational small molecule being studied for the treatment of solid tumours. It is in Phase 1 clinical development for this oncology indication. The drug is being evaluated in patients with advanced solid tumours who have normal kidney function or severe kidney impairment.

What does Osimertinib target?

Osimertinib is a small molecule developed by AstraZeneca for the treatment of solid tumours. As a targeted therapy in oncology, it is designed to interfere with specific pathways involved in tumour growth. The drug is currently in Phase 1 clinical trials to assess its safety and efficacy in patients with advanced solid tumours.

Who makes Osimertinib?

Osimertinib is developed by AstraZeneca PLC, a multinational pharmaceutical company listed on the stock exchange under the ticker AZN. The drug is being investigated as a treatment for solid tumours and is currently in Phase 1 clinical development. AstraZeneca is conducting trials to evaluate the drug's potential in oncology.

What phase is Osimertinib in?

Osimertinib is in Phase 1 clinical development. It is an investigational drug being studied for the treatment of solid tumours. The drug has received priority review designation from the FDA, indicating its potential significance. However, it is not yet approved and remains in early-stage clinical trials.

What clinical trials is Osimertinib in?

Osimertinib is being studied in a Phase 1 clinical trial with the identifier NCT02923947. This completed trial assessed the drug in patients with advanced solid tumours and normal kidney function or severe kidney impairment. The study enrolled 16 participants and was conducted in France, South Korea, and Spain.

Is Osimertinib the same as AZD9291?

Yes, Osimertinib is also known as AZD9291. It is an investigational small molecule being developed by AstraZeneca for the treatment of solid tumours. The drug is currently in Phase 1 clinical development and has been studied in a completed trial involving patients with advanced solid tumours and varying degrees of kidney function.