Intra participant dose escalation For phase I studies describe criteria to

Intra participant dose escalation for phase i studies

This preview shows page 30 - 32 out of 80 pages.

Intra-participant dose escalation For phase I studies, describe criteria to treat a DLT and criteria to treat the toxicity after the DLT period. If dose modifications or treatment delays are anticipated, please provide a dose de-escalation schema. The following format for an orally available agent is provided as an example and should be modified as appropriate for the protocol: Dose Level [Agent Name] Dose -2 XX mg, schedule -1 XX mg, schedule 0 XX mg, schedule +1 XX mg, schedule +2 XX mg, schedule +3 XX mg, schedule Note: All treatment modifications must be expressed as a specific dose or amount rather than as a percentage of the starting or previous dose (e.g., AUC dosing reductions must be by AUC dose levels). For combination studies, dose modifications/treatment delays for [CTEP and/or CIP IND Agent(s) or other IND agent] and [Other Agent(s)] may be presented separately or together, as appropriate. Use of a table format is recommended if applicable. Below are dose modification tables for the following adverse events: nausea, vomiting, diarrhea, neutropenia, and thrombocytopenia. Please use as appropriate. In addition, for your convenience, a blank dose modification table has been provided. Note in the text that if a participant experiences several adverse events and there are conflicting recommendations, the investigator should use the recommended dose adjustment that reduces the dose to the lowest level. Nausea Management/Next Dose for [Agent Name] Management/Next Dose for [Agent Name] ≤ Grade 1 No change in dose No change in dose Grade 2 Hold until ≤ Grade 1. Resume at same dose level. Hold until ≤ Grade 1. Resume at same dose level. Grade 3 Hold * until < Grade 2. Resume at one dose level lower, if indicated. ** Hold * until < Grade 2. Resume at one dose level lower, if indicated. ** Grade 4 Off protocol therapy Off protocol therapy * Participants requiring a delay of >2 weeks should go off protocol therapy. ** Participants requiring > two dose reductions should go off protocol therapy. Recommended management: antiemetics. 26
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NCI Protocol #: DF/HCC Protocol #: Protocol Version Date: Vomiting Management/Next Dose for [Agent Name] Management/Next Dose for [Agent Name] ≤ Grade 1 No change in dose No change in dose Grade 2 Hold until ≤ Grade 1. Resume at same dose level. Hold until ≤ Grade 1. Resume at same dose level. Grade 3 Hold * until < Grade 2. Resume at one dose level lower, if indicated. ** Hold * until < Grade 2. Resume at one dose level lower, if indicated. ** Grade 4 Off protocol therapy Off protocol therapy * Participants requiring a delay of >2 weeks should go off protocol therapy. ** Participants requiring > two dose reductions should go off protocol therapy. Recommended management: antiemetics. Diarrhea Management/Next Dose for [Agent Name] Management/Next Dose for [Agent Name] ≤ Grade 1 No change in dose No change in dose Grade 2 Hold until ≤ Grade 1. Resume at same dose level.
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