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Will it be difficult to recruit patients that are anthracycline...

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ReNova

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18/07/24

14:11

Post #: 74812863
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Originally posted by RaceOncology: ↑

A pretty good guess on the trial design Mason and good morning all from not so sunny Fremantle (the Bioshares conference wrapped upped last night). A few minor correction:

1. Since this trial is all about safety and cardioprotection we will only be giving one dose of bisantrene right before the doxorubicin dose after the lead in dose. This maps back to the animal studies and what is done with dexrazoxane. In the AML and later trials we will explore giving multiple doses to maximise the anticancer efficacy.

2. We will be using a wide range of cardio tests in addition to VO2peak such as Cardiac MRI, 3D echos, etc

3. Yes the patients will need to be anthracycline naive, and at least in the Phase 1a stage, without cardiac risk factors.

4. The first doses will probably start a little lower that you have guessed, but this is up to ethics.

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Will it be difficult to recruit patients that are anthracycline naive given that anthracyclines are used so much in SOC and patients that enrol in early stage trials have generally failed several lines of SOC treatment?

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