Results
end-organ damage, hemolysis, neutropenia
METASTASIS, HEMOLYSIS, NEUTROPENIA, ACUTE RESPIRATORY FAILURE
The trial activated at the Mayo Clinic on July 6, 2017, and at the 8 participating TBCRC sites beginning February 19, 2018. Enrollment was suspended April 2, 2018, after tolerability issues were identified. Five of the initial 12 patients had grade 4 or higher AEs, among which 4 were attributed as at least possibly related to alisertib (neutropenia [2], hemolysis [1], and acute respiratory failure [1]). In response, eligibility criteria were modified to limit those with end-organ damage, central nervous system metastasis, or an ECOG performance score greater than 1 from participating (eTable 2 in 