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Clinical Trial Summary

This is an open-label, non-randomized, multicenter phase Ib/II study, which is composed of a phase Ib dose escalation part and a phase II dose expansion part. Patients will receive selumetinib in combination with gefitinib 250mg daily. This study will enroll EGFR-mutated NSCLC patients who have developed acquired resistance to EGFR TKI treatment.


Clinical Trial Description

he primary objective of the dose escalation part is to determine the MTD and/or RP2D of selumetinib in combination with gefinitib. Once MTD and/or RP2D has been determined in the phase Ib dose escalation phase, study drug selumetinib with combination of 250mg QD dose of gefitinib will be further evaluated in a phase II dose expansion phase of the study. The purpose of the dose expansion phase is to evaluate the efficacy of selumetinib in combination of gefitinib and to further characterize the safety, and tolerability of the combination.

20 patients will be required in the phase II period. In the expansion phase, 10 patients with T790M and 10 patients without T790M will be enrolled. It is assumed that 20% response rate is the target of clinical interest. If the true response rate is 20%, the probability of observing no responses in a random sample of 10 patients is 0.107. The false negative rate for detecting a true 20% response rate in each cohort is approximately 10%. Each cohort will be enrolled 10 patients to evaluate the efficacy; therefore 20 patients will be enrolled in dose expansion part. Patients treated at the MTD and/or RP2D during the phase Ib will be considered as part of the required number of patients in the phase II. Patients at the MTD or RP2D cannot contribute to the 20 patients require for phase II part. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT02025114
Study type Interventional
Source National Taiwan University Hospital
Contact
Status Completed
Phase Phase 1/Phase 2
Start date September 2014
Completion date March 8, 2018

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