3] Nonstandard abbreviations: PI3K, phosphoinositide 3-kinase; AKT, RAC-[alpha] serine/threonine protein kinase; PRAS40, proline-rich AKT substrate of 40 kDa; mTOR, mammalian target of rapamycin; PD, pharmacodynamic; PK, pharmacokinetic; RANKL, receptor activator of nuclear factor [kappa]B ligand; NTx, N-terminal telopeptide; FDA, US Food and Drug Administration; MMR, major molecular response; CA125, cancer antigen 125; CTCAE
, Common Terminology Criteria for Adverse Events (criteria).
The severity of adverse events was assessed using the NCI (National Cancer Institute) CTCAE
(Common Terminology Criteria for Adverse Events) (version 3.
9]/l, then resume at 400 mg/d if recovery within 2 weeks In the event of recurrent grade 3-4 toxicity or delayed recovery, dose reduction to 300 mg Anaemia Inhibition of c-KIT, Dose interruption is which is essential for not indicated for the development of toxicity of any grade normal blood cells Dose reductions may Suppression of the help in patients with malignant clone until chronic anaemia normal haematopoiesis replaces the marrow Note: Toxicity grades according to CTCAE
(Common Terminology Criteria for Adverse Events) criteria.
The main eligibility criteria were ECOG performance status 2; no evidence of brain metastases; no diarrhea or skin rash CTCAE
> 1; adequate bone marrow, liver, and renal function and life expectancy of at least 3 months.
Response was assessed per IMWG criteria and adverse events per CTCAE
The majority of adverse events (AEs) were CTCAE
grade 1 or 2.