TerminatedPhase 1/2

A Study of ASP2215 in Combination With Erlotinib in Subjects With Epidermal Growth Factor Receptor (EGFR) Activating Mutation-Positive (EGFRm+) Advanced Non-Small-Cell Lung Cancer (NSCLC) Who Have Acquired Resistance to an EGFR Tyrosine Kinase Inhibitor (TKI)

Stopped: Study terminated due to adverse events related to the combination therapy

Japan10 participantsStarted 2015-09-08

Plain-language summary

The purpose of the Phase 1b part of the study was to evaluate the safety and tolerability of ASP2215 in combination with erlotinib and determine the recommended phase 2 dose (RP2D) of ASP2215. The purpose of the Phase 2 part of the study was to evaluate the objective response rate (ORR) of the RP2D of ASP2215 in combination with erlotinib.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Agree not to try to become pregnant during the study and for 45 days after the final study drug administration
✓. And had a negative serum pregnancy test at screening
✓. And, if heterosexually active, agreed to consistently use 2 forms of highly effective birth control

What they're measuring

Number of Participants With Dose Limiting Toxicities (DLTs)

Timeframe: Cycle 1 and Cycle ≥2 (up to 141 days)

Number of Participants With Adverse Events

Timeframe: From first dose of study drug up to 30 days after the last dose of study (maximum study drug exposure 114 days)

Trial details

NCT IDNCT02495233

SponsorAstellas Pharma Global Development, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2016-09-28

Results submitted2018-12-10

View on ClinicalTrials.gov More Non-Small-Cell Lung Cancer trials