Selumetinib in Combination With Gefitinib in NSCLC Patients

Sponsor
National Taiwan University Hospital
Study ID
NCT02025114
Phase
PHASE1/PHASE2
Status
Completed

Conditions

  • Non-small Cell Lung Cancer (NSCLC)

Eligibility Criteria

Sex
ALL
Age
20 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • selumetinib — DRUG
    The starting dose of selumetinib in combination with the standard dose of gefitinib (250mg QD) on a continuous dosing schedule will be 50mg QD. Total 3 doses of selumetinib will be tested (50mg QD, 50mg BID and 75mg BID).

Study Details

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.

Key Dates

Start date
Sep 30, 2014
Status verified
Jul 2018
Primary completion
Mar 8, 2018
Completion
Mar 8, 2018

Study Design

Enrollment
34 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Capsule
    The starting dose of selumetinib in combination with the standard dose of gefitinib (250mg QD) on a continuous dosing schedule will be 50mg QD. Total 3 doses of selumetinib will be tested (50mg QD, 50mg BID and 75mg BID).

Primary Outcome Measure

To determine the MTD and/or RP2D [ Time Frame: an expected average of 18 weeks ]

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