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Thursday, February 08, 2018 2:20:09 AM
“In this Phase 2 study, two different short-term treatment regimens of Kevetrin will be evaluated for safety, tolerability, changes in biomarkers/objective tumor response, and to evaluate the pharmacokinetics of Kevetrin when administered to subjects with platinum-resistant/refractory ovarian cancer.”
And,
“Primary Outcome Measures :
Incidence of Treatment-Emergent Adverse Events [ Time Frame: 6 Weeks ]
Reporting of Adverse Events, and severity of adverse events
Evaluate changes in biomarkers between pre-treatment sample and post-treatment sample [ Time Frame: 3 Weeks ]
Changes in RNA and/or protein level of pre-specified biomarkers associated with the p53 signalling pathway and apoptosis will be compared between pre-treatment sample (tumor biopsy, ascites fluid, and peripheral blood) and post-treatment sample (tumor biopsy, ascites fluid, and peripheral blood)”
https://clinicaltrials.gov/ct2/show/NCT03042702?cond=Ovarian+cancer+Kevetrin&rank=1
They met primary outcomes and will now work on an oral formulation before continuing with a new Phase 2 following a bridge study.
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