drugset
drugset / Trial / NCT00912275

Lapatinib in Combination With Oral Vinorelbine for Metastatic Breast Cancer

NCT00912275 ↗

Phase 1/2 Completed 46 enrolled National Taiwan University Hospital GlaxoSmithKline · collab
NaSingle-groupOpen-labelTreatment

Summary

Phase I part: to determine the recommended dose, and observe the preliminary response and safety profile of the combination of oral lapatinib with vinorelbine in patients with ErbB2 positive metastatic breast cancer. Phase II part: to determine the progression free survival, response rate, and to evaluate the safety profile of the combination of oral lapatinib with vinorelbine in patients with ErbB2 positive metastatic breast cancer. Phase I part has been completed. Phase II part is underway.

Timeline

Start
2008-11-24
Primary completion
2015-03-31
Completion
2017-07-07

Drugs

EvaluationDrugModalityDoseRoute
Subject Lapatinib Small molecule 1000 mg Oral
Subject Lapatinib Small molecule 1250 mg Oral
Subject Vinorelbine Small molecule 30 mg/m2 Oral
Subject Vinorelbine Small molecule 40 mg/m2 Oral
Subject Vinorelbine Small molecule 50 mg/m2 Oral
Subject Vinorelbine Small molecule 60 mg/m2 Oral
Subject Vinorelbine Small molecule 80 mg/m2 Oral

Indications

breast cancer