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scottsmith

04/09/18 3:17 PM

#223669 RE: Chronic #223668

Leo didn’t fool many with this PR it seems.
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frrol

04/09/18 3:19 PM

#223671 RE: Chronic #223668

"BTW there was nothing in the trial design mentioning high concentration vs. low concentration cisplatin."



Go to clinicaltrial.org. The two concentration arms are there in the inclusion criteria.

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sox040713

04/09/18 3:39 PM

#223675 RE: Chronic #223668

4. Have a plan to receive a standard cisplatin chemotherapy regimen administered weekly (30-40 mg/m2) or approximately every 21 days (80-100 mg/m2)



https://clinicaltrials.gov/ct2/show/NCT02324335?term=cellceutix&rank=6

Subgroup analysis helps the design for Phase 3 and increases its odds of success.
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PlentyParanoid

04/09/18 3:49 PM

#223678 RE: Chronic #223668

Yes, classic in the sense of common practise. Take a look at Galera's phase I trial paper for GC4419 (sorry but reading is required, dose reductions are in the text) to take a gander at their problems with high concentration cisplatin. Doctors have their pick of sadistic ways in the name of fuzzy benefits: cisplatin around 30 to 40 mg QW or about 100 mg Q3W. The latter is known to lead to dose reductions and brusts of SOM and probably therefore favorite of some less congenial characters.