drugset / Trial / NCT02338245

Study of ASLAN001 in Combination With Capecitabine in MBC That Has Failed on Prior Trastuzumab

NCT02338245

Phase 2 Completed 200 enrolled ASLAN Pharmaceuticals
RandomizedParallel-groupOpen-labelTreatment

Summary

This is an open-label, randomized, parallel group Phase 2A/2B study to evaluate the clinical activity of ASLAN001 in combination with capecitabine compared with lapatinib in combination with capecitabine in patients with HER2 positive metastatic breast cancer that has failed on prior trastuzumab therapy.

Timeline

Start
2014-12-29
Primary completion
2016-05-19
Completion
2016-08-25

Drugs

EvaluationDrugModalityDoseRoute
Subject Capecitabine Small molecule 1000 mg/kg Oral
Subject Capecitabine Small molecule 1000 mg/m2 Oral
Comparator Lapatinib Small molecule 1250 mg Oral
Subject Varlitinib Small molecule 400 mg Oral

Indications