{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"1.4"}]}],"title":"Eribulin Mesilate"},{"categories":[{"measurements":[{"groupId":"OG000","value":"40"}]}],"title":"Irinotecan Hydrochloride"}],"denoms":[{"counts":[{"groupId":"OG000","value":"12"}],"units":"Participants"}],"description":"The RP2D was evaluated based on a review of the outcomes of safety (including dose limiting toxicities \\[DLTs\\]), tumor assessments, and pharmacokinetic (PK) in Phase 1 by investigators and the study team.","groups":[{"description":"All participants received eribulin mesilate 1.4 mg/m\\^2 intravenous infusion on Days 1 and 8 and irinotecan hydrochloride 20 mg/m\\^2 or 40 mg/m\\^2 intravenous infusion on Days 1 to 5 (schedule A) and irinotecan hydrochloride 100 mg/m\\^2 or 125 mg/m\\^2 intravenous infusion on Days 1 and 8 (schedule B) in 21-day treatment cycle until disease progression, development of intolerable toxicity or withdrawal of consent.","id":"OG000","title":"Phase 1: All Participants"}],"paramType":"NUMBER","populationDescription":"The Dose Evaluable Set (DES) for Phase 1 included all the participants who completed Cycle 1 treatment and were evaluated for DLTs and those who discontinued treatment during Cycle 1 due to DLTs.","reportingStatus":"POSTED","timeFrame":"First dose of study drug up to Cycle 1 (Cycle length=21 days)","title":"Phase 1: Recommended Phase 2 Dose (RP2D) of Eribulin Mesilate in Combination With Irinotecan Hydrochloride","type":"PRIMARY","unitOfMeasure":"mg/m^2"}