NCI/CTEP #9903: A Phase 1B Study of AZD9291 in Combination with Navitoclax in EGFR-Mutant Non-Small Cell Lung Cancer Following Resistance to Initial EGFR Kinase Inhibitor

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NCI/CTEP #9903: A Phase 1B Study of AZD9291 in Combination with Navitoclax in EGFR-Mutant Non-Small Cell Lung Cancer Following Resistance to Initial EGFR Kinase Inhibitor

Primary Objectives: (1) To determine the safety and tolerability of AZD9291 in combination with navitoclax in patients with EGFR-mutant NSCLC following resistance to prior EGFR TKI. (2) To evaluate the feasibility of treatment with AZD9291 plus navitoclax for patients with T790M-mediated acquired resistance to EGFR TKI.
Secondary Objectives: (1) To study the pharmacokinetic profile of the combination of AZD9291 plus navitoclax. (2) To observe and record anti-tumor activity.
Correlative Objectives: (1) To study plasma genotype levels as a response biomarker in patients with EGFR-mutant lung cancer. (2) To explore tissue biomarkers of apoptosis and their association with treatment response.

Protocol Number: 031610
Phase: Phase I
Applicable Disease Sites: Lung
Drugs Involved: ABT-263
AZD9291 (Osimertinib)
Principal Investigator: Jyoti Malhotra
Research Nurse: Michelle Orlick
Scope: National
Therapies Involved: Chemotherapy multiple agents systemic
Participating Institutions: Rutgers Cancer Institute of New Jersey

For further information on this clinical trial, please contact us at 732-235-8675 or cinjclinicaltrials@cinj.rutgers.edu.

 

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