Does anybody know if the trial protocol for the 1a/b is available anywhere or any details of the trial? I could find no reference to it on clinical trials.gov.
I'm most interested in how they plan to evaluate the 'cardioprotective' effect of bisantrene in combination with doxo. What endpoints they will assess and what they compare with to provide evidence of cardioprotection. Do they risk stratify for background cardiovascular risk in the trial population? What cumulative doxo doses are permitted. How will they know there's a cardioprotective effect of the combination, for example will they compare with historic data for cardiac adverse events for doxo alone?
Ann: Race Appoints George Clinical for Phase 1 Trial of RC220, page-59
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