Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02908750 | Study to Assess the Effect of Osimertinib (TAGRISSO™ ) on Blood Levels of Fexofenadine in Patients With EGFRm+ NSCLC | PHASE1 | COMPLETED | 24 | — | — | Mar 2, 2017 | Oct 11, 2022 | Nov 14, 2022 | 7 | France, South Korea +1 |
To characterize the pharmacokinetics of fexofenadine by assessment of maximum plasma fexofenadine concentration.
To characterize the pharmacokinetics of fexofenadine by assessment of area under the plasma concentration time curve from zero to infinity
| Arm | Type | Description |
|---|---|---|
| osimertinib and fexofenadine | EXPERIMENTAL | Sequential treatments of fexofenadine alone followed by osimertinib + fexofenadine, followed by osimertinib alone, followed by osimertinib + fexofenadine |
| Name | Type | Description |
|---|---|---|
| Fexofenadine tablet dosing | DRUG | Fexofenadine (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 dosing | DRUG | Osimertininb 80 mg taken once daily on Day 1 and Days 4 to 41 in Treatment Period 2 |
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...