RecruitingPhase 1NCT04085315

Alisertib in Combination With Osimertinib in Metastatic EGFR-mutant Lung Cancer

A Phase I/Ib Study of Alisertib in Combination With Osimertinib in Metastatic EGFR-mutant Lung Cancer


Sponsor

Collin Blakely

Enrollment

38 participants

Start Date

Nov 12, 2019

Study Type

INTERVENTIONAL

Conditions

Summary

This phase I/Ib trial studies the side effects and best dose of alisertib when given together with osimertinib in treating patients with EGFR-mutated stage IV lung cancer. Alisertib may stop the growth of tumor cells by blocking a specific protein (Aurora Kinase A) that researchers believe may be important for the growth of lung cancer. Osimertinib may reduce tumor growth by blocking the action of a certain mutant protein (EGFR). This study may help researchers test the safety of alisertib at different dose levels in combination with osimertinib, and to find out what effects, good and/or bad, it has on EGFR-mutated lung cancer.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether adding a drug called alisertib to the standard targeted therapy osimertinib can help patients with advanced lung cancer that has a specific genetic change (EGFR mutation) and has stopped responding to osimertinib alone. **You may be eligible if...** - You are 18 or older - You have stage IV non-small cell lung cancer with an EGFR mutation confirmed by a lab test - You are currently receiving osimertinib and your cancer has started growing again (or you are stable on first-line osimertinib) - You can swallow pills and your organ function is adequate - You are not pregnant and agree to use contraception **You may NOT be eligible if...** - You have had a bone marrow or organ transplant - You have bowel conditions that would prevent pill absorption - You have severe heart problems or an abnormal heart rhythm - You have uncontrolled brain metastases requiring steroids - You have another cancer diagnosed within the past 3 years (some exceptions apply) - Your cancer has a known resistance mutation better treated by another drug Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGOsimertinib

Osimertinib is a medication used to treat non-small-cell lung carcinomas with a specific mutation. It is a third-generation epidermal growth factor receptor tyrosine kinase inhibitor. Patients will be receiving full dose osimertinib (80 mg PO daily) as part of the patient's current standard of care.

DRUGAlisertib

Alisertib is an orally available selective aurora A kinase inhibitor. Alisertib will be administered to eligible patients in combination with osimertinib at doses ranging from 20 mg to 50 mg PO twice daily on days 1-3, 8-10, and 15-17 of a 28-day cycle. The starting alisertib dose for Cohort 1 will be 30 mg twice daily (dose level 1).


Locations(1)

University of California, San Francisco

San Francisco, California, United States

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NCT04085315


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