drugset / Trial / NCT05400915

Two-Part, Phase Ib/II, Open Label, Single-Arm, Multi-center Study to Evaluate the Safety and Efficacy of Varlitinib in Combination With Weekly Paclitaxel in EGFR/HER2 Co-expressing Advanced or Metastatic Gastric Cancer Patients

NCT05400915

Phase 1/2 Completed 27 enrolled Yonsei University
NaSingle-groupOpen-labelTreatment

Summary

Phase Ib part of this study determines the recommended phase II dose schedule based on ASLAN001-004 phase Ib (dose-confirmation study of Varlitinib combined with weekly paclitaxel and carboplatin or trastuzumab (Herceptin) in advanced solid tumours). Phase II part of this study further assesses the safety and clinical efficacy of this combination treatment as a second line treatment in EGFR/HER2 co-expressing advanced or metastatic gastric cancer.

Timeline

Start
2019-07-23
Primary completion
2021-12-13
Completion
2022-06-13

Drugs

EvaluationDrugModalityDoseRoute
Subject Paclitaxel Small molecule Intravenous
Subject Varlitinib Small molecule 300 mg Oral

Indications