This phase 1, open-label study comprised a dose-escalation phase and a dose-expansion phase . During dose escalation, patients received oral avapritinib at starting doses ranging from 30 to 400 mg QD in continuous 28-d treatment cycles. Dose escalation followed a 3 + 3 design until the MTD or RP2D was determined. During part 1, intra-patient dose escalation to assess dose levels not exceeding the MTD was allowed.
In the event a patient was withdrawn from study drug administration or the follow-up phase of the study, the medical monitor was informed. If there was a medical reason for withdrawal, the patient remained under the supervision of the investigator or designee until the condition returned to baseline or stabilized.
The safety population included all enrolled patients and was used to report AEs and PROs . The dose-determining population included all patients in a cohort in part 1 who received ≥21 prescribed avapritinib doses in C1 and completed follow-up through C1, or experienced DLT. The determination of the MTD and RP2D were based on the dose-determining population.
Spleen response was determined for patients with baseline splenomegaly and was assessed by palpation or spleen volume by imaging ; presence of either criterion was considered a response. DOR started at the first evidence of a response in any evaluable C-finding and ended at the time a response was lost . For patients who were still responding at the time of analysis, DOR was censored at the latest time point that the patient is assessed as having clinical improvement or better.
Health Health Latest News, Health Health Headlines
Similar News:You can also read news stories similar to this one that we have collected from other news sources.
Source: NatureMedicine - 🏆 451. / 53 Read more »
Source: NatureMedicine - 🏆 451. / 53 Read more »