Alisertib in Combination With Osimertinib in Metastatic EGFR-mutant Lung Cancer
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorCollin Blakely
About this trial
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 criteria
Qualifiers
Patients must have histologically confirmed stage IV non-small cell lung cancer.
Male or female patients >=18 years of age
Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
Documented activating EGFR mutation (Exon 19 deletion, Exon 19 insertion, E709K, G719X, S768I, V769L, T790M, L833F, L833V, V834L, H835L, L858R, A859S, K860I, L861Q, A871E, V843I, or H870R) on tumor sample or cell-free DNA sample performed in Clinical Laboratory Improvement Amendments (CLIA)-approved laboratory.
Disqualifiers
Radiation therapy to more than 25% of the bone marrow. Whole pelvic radiation is considered to be over 25%.
Prior allogeneic bone marrow or organ transplantation
Known Gastrointestinal (GI) disease or GI procedures that could interfere with the oral absorption or tolerance of alisertib. Examples include, but are not limited to partial gastrectomy, history of small intestine surgery, and celiac disease
Inability to swallow oral medication or inability or unwillingness to comply with the administration requirements related to alisertib.
Trial design
Treatments tested in this trial
- Osimertinib
- Alisertib
Treatment groups
38 Participants
are divided into 4 treatment groupsSponsors and collaborators
Collin Blakely
Lead sponsor
University of California, San Francisco
Sponsor institution
Puma Biotechnology, Inc.
Collaborator
Source ClinicalTrials.gov