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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

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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
Scope: National
Therapies Involved: Chemotherapy multiple agents systemic
Participating Institutions: Rutgers Cancer Institute of New Jersey
Inclusion & Exclusion Criteria

Please note that we have obtained the inclusion and exclusion criteria information from the National Institutes of Health’s clinical trials web site www.clinicaltrials.gov. The listed criteria may not necessarily reflect recent amendments to the protocol and the current criteria. For additional information on this trial or other available clinical trials please contact the research nurse.

For further information about clinical trials, please contact us at 732-235-8675.

 

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