drugset
drugset / Trial / NCT02648425

Safety and Tolerability of ASLAN001 in Combination With Cisplatin and 5-FU or Cisplatin and Capecitabine

NCT02648425 ↗

Phase 1 Completed 31 enrolled ASLAN Pharmaceuticals
Non-randomizedParallel-groupOpen-labelTreatment

Summary

This is a phase IB study to assess the safety and tolerability of ASLAN001 when given in combination with either Cisplatin and 5-Fluorouracil or Cisplatin and Capecitabine, with a view to identifying the recommended Phase II dose.

Timeline

Start
2014-08-05
Primary completion
2017-06-12
Completion
2017-09-15

Drugs

EvaluationDrugModalityDoseRoute
Subject Varlitinib Small molecule 300 mg —
Subject Varlitinib Small molecule 400 mg —
Subject Varlitinib Small molecule 500 mg —
Background Capecitabine Small molecule 1000 mg/m2 Oral
Background Cisplatin Other / unclassified 35 mg/m2 Intravenous
Background Cisplatin Other / unclassified 60 mg/m2 Intravenous
Background Cisplatin Other / unclassified 80 mg/m2 Intravenous
Background Leucovorin Small molecule 300 mg/m2 Other
Background fluorouracil Small molecule 800 mg/m2 Intravenous
Background fluorouracil Small molecule 2000 mg/m2 Intravenous

Indications

neoplasm