_Protocols__UCDCC #171_ucdcc171diagram

_Protocols__UCDCC #171_ucdcc171diagram - lapatinib alone...

Info iconThis preview shows page 1. Sign up to view the full content.

View Full Document Right Arrow Icon
UCD#171/GSK 104241 Lapatinib and Vinorelbine Phase I Version 2: December 26, 2005 19 Lapatinib PK sampling (Day 8): predose vinorelbine (single draw, at trough, to confirm patient has been taking drug) Treatment Arm B (Intermittent Dosing): Upon determination of the MTD on ARM A accrual to ARM B will begin. Accrual to ARM B and the PK cohort of ARM A may occur simultaneously. Lapatinib will be given orally day 2-5, day 9-12 and day 16-25, starting the day of vinorelbine administration. It should be taken in the morning with 200 ml of water. Tablets should be taken 1 hour before and 1 hour after meals. Vinorelbine will be given intravenously weekly, 3 out of 4 weeks. In the absence of disease progression or unacceptable toxicity, treatment with vinorelbine and lapatinib may continue indefinitely on the same dose and schedule. After 6 cycles of vinorelbine patients may continue on
Background image of page 1
This is the end of the preview. Sign up to access the rest of the document.

Unformatted text preview: lapatinib alone. Dose Level Lapatinib (mg) Days 2-5, 9-12 and 16-25 Vinorelbine (mg/m2) Weekly d1,8,15 • 500 20 2 1000 20 3 1250 20 4 1250 25 *If the MTD is not reached at the final dose level then continued dose escalation of the lapatinib and vinorelbine will be considered and the protocol amended. Treatment Schema (repeated every 28 days): Day 1 Day 2-5 Day 8 Day 9-12 Day 15 Day 16-25 Day 29 Lapatinib 1 X X X Vinorelbine 2 X X X X 1 Lapatinib – PO administration 2 Vinorelbine – IV administration 9.2 Rules for Dose Escalation no DLT* Escalate Dose Treat 3 Patients 2 or 3 Patients Stop, Expand at new dose with DLT Lower Dose 1 Patient Expand Dose: with DLT 3 More Patients More DLT No More DLT (2+/6) (1/6) Stop, Expand Escalate Dose Lower Dose...
View Full Document

This note was uploaded on 12/30/2010 for the course BST 252 taught by Professor Tsodikov during the Winter '06 term at UC Davis.

Ask a homework question - tutors are online