The abstracts are now available to the public at the ASCO website... here is the one you are inquiring about... TPS5260
The 58% refers to partial response or stable disease... I think this is is actually old data from an earlier trial... the current trial is to assess that and other data...
Background: Ovarian clear cell carcinoma (OCCC) represents nearly 15% of all epithelial ovarian carcinomas (EOC). This histology is associated with resistance to chemotherapy and a worse prognosis. VEGF has been found to be strongly expressed in OCCC. Somatic mutations in the ARID1A (the AT-rich interactive domain 1A gene that encodes BAF250a, a key component of the SWI/SNF chromatin remodeling complex) has also been demonstrated in 46-57% of OCCCs. Alteration of this chromatin remodeling complex may result in upregulation and overexpression of Aurora A.
ENMD-2076 is a multi-target kinase inhibitor, which has selective activity against Aurora A and multiple antiangiogenesis and lymphangiogenesis targets.
In a Phase II study in platinum-resistant EOC, 58% of the patients treated with single agent ENMD-2076 showed partial response or stable disease, the PFS at 6 month was 22% with a median time to progression of 3.6 months. Two out of 3 patients with OCCC who were enrolled had a longer PFS than the median.
Methods: This is a multi-center, Phase II study, in patients with recurrent OCCC to assess response rate and progression free survival rate, as primary endpoints, and duration of overall response, as a secondary endpoint, of single agent ENMD-2076 275 mg/day. Exploratory endpoints include association of somatic mutations in PI3KCA, ARID1A and PTEN, and ARID1A and PTEN expression with outcome and response. Patients ECOG =2, with histologically documented diagnosis of recurrence OCCC, any number of prior treatment regimens (chemotherapy, biologics or other target therapies except for Aurora A targeted therapies), and measurable disease (RECIST criteria 1.1) are eligible.
Based on data from previous studies, a sample size of 36 patients will provide 95% power to detect an improvement in response rate from 10 to 30% and 90% power to detect an increase in 6 month PFS from 20 to 40%.
Since September 2013, 6 patien Clinical trial information: NCT01914510.
