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Fexofenadine dosing

Phase 1

Non Small Cell Lung Cancer | Small molecule | Oncology |AstraZeneca PLC|Last Updated: Nov 14, 2022

Target and mechanism

ModalitySmall molecule

Also known as Fexofenadine tablet dosing

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment24

FDA Designations

No designations recorded

Clinical trial landscape

Fexofenadine dosing · 1 trial · 1 indication

Phase 1 1
NCT02908750Study to Assess the Effect of Osimertinib (TAGRISSO™ ) on Blood Levels of Fexofenadine in Patients With EGFRm+ NSCLCNon Small Cell Lung Cancer
COMPLETED24 Analytics
PHASE1COMPLETED
Study to Assess the Effect of Osimertinib (TAGRISSO™ ) on Blood Levels of Fexofenadine in Patients With EGFRm+ NSCLC
Non Small Cell Lung CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

Fexofenadine Cmax (alone and in combination with osimertinib)
Blood samples are collected pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 24, 36, 48, 60, 72 on Day 1 in Period 1 and Day 1 and Day 39 in Period 2

To characterize the pharmacokinetics of fexofenadine by assessment of maximum plasma fexofenadine concentration.

Fexofenadine AUC (alone and in combination with osimertinib)
Blood samples are collected pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 24, 36, 48, 60, 72 on Day 1 in Period 1 and Day 1 and Day 39 in Period 2.

To characterize the pharmacokinetics of fexofenadine by assessment of area under the plasma concentration time curve from zero to infinity

Secondary Endpoints

Fexofenadine tmax (alone and in combination with osimertinib)
Blood samples are collected pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10 24, 36, 48, 60, 72 on Day 1 in Period 1 and Day 1 and Day 39 in Period 2
Fexofenadine AUC0-t (alone and in combination with osimertinib)
Blood samples are collected pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10 24, 36, 48, 60, 72 on Day 1 in Period 1 and Day 1 and Day 39 in Period 2
Fexofenadine CL/F (alone and in combination with osimertinib)
Blood samples are collected pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10 24, 36, 48, 60, 72 on Day 1 in Period 1 and Day 1 and Day 39 in Period 2
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
osimertinib and fexofenadineEXPERIMENTALSequential treatments of fexofenadine alone followed by osimertinib + fexofenadine, followed by osimertinib alone, followed by osimertinib + fexofenadine

Interventions

NameTypeDescription
Fexofenadine tablet dosingDRUGFexofenadine (P-gp substrate) 120mg taken once daily on Days 1 in Treatment Period 1 and Day 1 and Day 39 in Treatment Period 2
Osimertininb tablet dosingDRUGOsimertininb 80 mg taken once daily on Day 1 and Days 4 to 41 in Treatment Period 2
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Eligibility Criteria

Age Range18 Years to 130 Years
SexALL
Healthy VolunteersNo
Study Sites7

Inclusion Criteria: * Male or female, ≥18 years * Histological or cytological confirmation diagnosis of NSCLC * Radiological documentation of disease progression while receiving previous continuous treatment with an EGFR-TKI. * Confirmation that the tumour harbours an EGFR mutation known to be asso...

Countries:FranceSouth KoreaSpain
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Competitive Landscape -Non-Small Cell Lung Cancer 387 trials (matched to "Non Small Cell Lung Cancer")