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ClinicalTrials.gov Identifier: NCT01653028

Posted: Thu Feb 21, 2013 4:24 pm
by Olga
New clinical trial is open that lists ASPS as one of the participating sarcomas:
Alisertib in Treating Patients With Advanced or Metastatic Sarcoma
http://clinicaltrials.gov/ct2/show/NCT01653028
Alisertib is the investigational oral drug MLN8237 , a small-molecule Aurora A kinase (AAK) inhibitor, that was tested in Phase I study of aurora A kinase inhibitor MLN8237 in advanced solid tumors: safety, pharmacokinetics, pharmacodynamics, and bioavailability of two oral formulations.
http://www.ncbi.nlm.nih.gov/pubmed/22767670
One (1%) patient achieved a partial response lasting for more than 1 year and received MLN8237 for 51 cycles; 20 (23%) patients achieved stable disease for ≥3 months.
I am afraid that ASPS might be included on a basis that some of the ASPS patients achieved stable disease for ≥3 months which is apparently not a reliable sign for ASPS if the progression was identified by the REGIST criteria i.e. 25% growth.