UCD#171/GSK 104241 Lapatinib and Vinorelbine Phase I Version 2: December 26, 2005 21 The most common toxic effects of GW572016 are diarrhea which may lead to dehydration, nausea, fatigue, rash (including dermatitis acneiform), vomiting and anorexia. Lapatinib (GW572016) Dose Levels and Dose Reduction Schedule Existing Lapatinib Dose (mg) Modified Lapatinib Dose (mg) 1500 1250 1250 1000 1000 750 750 500 500 250 250 Remove from study Table 10.2. Dose Reduction Criteria and Guidelines for Management of Lapatinib (GW572016) Associated Toxicity Toxicity Grade Guideline for management GW572016 dosage modification* 1 No intervention None 2 None; If unacceptable to patient or medically concerning then hold until recovery to < grade 1, up to 21 days*. Restart at same dose**. Diarrhea > 3 ( despite optimal use of loperamide) Loperamide (4 mg at first onset, followed by 2 mg every 2–4 hrs until diarrhea free for 12 hrs) Hold until recovery to < grade 1, up to 21 days*. And then
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