CONTROL Study Update: ASCO 2019

The Phase 2 CONTROL study is an international, open-label, sequential-cohort, Phase 2 study investigating the effects of loperamide prophylaxis alone or with add-on budesonide, a locally-acting corticosteroid used for inflammatory gastrointestinal conditions, or colestipol, a bile acid sequestrant, on NERLYNX-associated diarrhoea. Investigators have found that the addition of budesonide or colestipol to loperamide prophylaxis given for 1-2 cycles reduces the severity and duration of diarrhoea in patients treated with NERLYNX, improving tolerability. The initial data suggests that the benefits appear even greater in the dose escalation cohort, although this cohort is yet to complete enrolment.

Abstract link: https://abstracts.asco.org/239/AbstView_239_265427.html

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