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_Protocols__UCDCC #171_ucdcc171stat

_Protocols__UCDCC #171_ucdcc171stat - UCD#171/GSK 104241...

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UCD#171/GSK 104241 Lapatinib and Vinorelbine Phase I Version 2: December 26, 2005 29 The accrual rate to this trial is expected to be at least 4 patients per month. The phase I study is expected to accrue a minimum of 12 patients to a maximum 54 patients. In addition there will be 12 patients accrued in the “PK Cohort” of ARM A, once DLT is determined (for possible maximum total of 66 patients). The objective of this study is to assess the safety and feasibility of combining chronic oral lapatinib in combination with vinorelbine and determine the MTD (maximum tolerated dose). This trial will seek to determine the tolerability and MTD of lapatinib in combination with vinorelbine. Toxicities are to be graded according to the National Cancer Institute Common Terminology Criteria (NCI CTC, Version 3.0). A copy of the CTCAE version 3.0 can be downloaded from the CTEP home page (http://ctep.info.nih.gov). Dose Limiting Toxicity (DLT) is defined as any of the following: Grade 4 thrombocytopenia (platelet count < 25,000/mm 3 ).
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  • Winter '06
  • Tsodikov
  • Absolute neutrophil count, dLt, Maximum Tolerated Dose, common terminology criteria, patients experience DLT, Dose Limiting Toxicity

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