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

2019-09-16 03:26:48 | BioPortfolio

Summary

This is a phase I/Ib, open-label, single-center, single-arm study of alisertib and osimertinib for patients with stage IV EGFR-mutated lung cancer, incorporating both a dose escalation and dose-expansion phase

Description

The dose-escalation phase will consist of a modified 3+3 dose escalation and will be open to patients with metastatic lung cancer with an activating EGFR mutation who have progressed on and are currently receiving osimertinib therapy. The dose-escalation and expansion phases will be open to patients who have received any number of therapies as long as they are currently being treated with and tolerating osimertinib 80 mg orally once per day, and who have demonstrated radiographic progression by RECIST 1.1 criteria on their most recent scan.

Primary Objective:

To determine the safety and tolerability of the combination osimertinib + alisertib in patients with advanced EGFR-mutant NSCLC and identify a recommended phase II dose.

Secondary Objectives:

1. To evaluate the clinical efficacy of adding alisertib to osimertinib compared to "historical" data of platinum doublet chemotherapy in patients who have progressed on osimertinib monotherapy.

2. To explore tumor biomarkers, including TPX2, that predict response to osimertinib + alisertib.

3. To evaluate alisertib and osimertinib pharmacokinetics

4. To evaluate the CNS response rate of alisertib + osimertinib

Patients may continue treatment indefinitely until disease progression, intolerance, or other contraindication to study treatment.

Study Design

Conditions

Lung Cancer Metastatic

Intervention

Osimertinib, Alisertib

Location

University of California, San Francisco
San Francisco
California
United States
94143

Status

Recruiting

Source

University of California, San Francisco

Results (where available)

View Results

Links

Published on BioPortfolio: 2019-09-16T03:26:48-0400

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