drugset / Trial / NCT01097512

AS703569 and Gemcitabine Combination in Advanced Malignancies

NCT01097512 ↗

Phase 1 Completed 66 enrolled Merck KGaA, Darmstadt, Germany
Non-randomizedParallel-groupOpen-labelTreatment

Summary

In clinical practice and research, combination of anticancer agents is often used to improve efficacy of treatment. In vitro and in vivo experiments have shown additive-synergistic anti-tumour effects of AS703569 treatment when combined with gemcitabine. Specifically, additive-synergistic anti-tumour effects were noticed when the two agents were given sequentially and not concomitantly i.e. AS703569 given the day before or the day after gemcitabine. This trial was designed to investigate in parallel two regimens testing sequential administration of AS703569 either the day after gemcitabine infusion, (Regimen 1) or the day before (Regimen 2).

Timeline

Start
2007-06
Primary completion
2010-07
Completion
2011-02

Drugs

EvaluationDrugModalityDoseRoute
Subject CENISERTIB Small molecule 10 mg/m2 Oral
Subject CENISERTIB Small molecule 37 mg/m2 Oral
Subject Gemcitabine Small molecule 1000 mg/m2 —