Dose-limiting toxicity for AE37 Sample Clauses

Dose-limiting toxicity for AE37. If Grade 3 systemic toxicity that require a ≥ 2 week delay in starting Cycle 2 is observed during the safety run-in or in > 25% (4 or more) of patients, the AE37 dose will be de- escalated to 500 micrograms (dose level −1) to complete stage I accrual. If systemic toxicity occurs in 3 or more patients at this dose (dose level −1) accrual will be halted and the toxicity reviewed by the study team.
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