drugset / Trial / NCT01192165

Safety and Tolerability Study of GSK1120212, a MEK Inhibitor, in Combination With Docetaxel, Erlotinib, Pemetrexed, Pemetrexed + Carboplatin, Pemetrexed + Cisplatin, or Nab-Paclitaxel

NCT01192165 ↗

Phase 1 Completed 169 enrolled GlaxoSmithKline
Non-randomizedSingle-groupOpen-labelTreatment

Summary

The purpose of this study is to determine what dose of GSK1120212 can be given safely in combination with at least one other drug that is already approved to treat cancer. This study will test the safety of up to 6 different GSK1120212 study treatment combinations (GSK1120212 plus either docetaxel, erlotinib, pemetrexed, pemetrexed + carboplatin, pemetrexed + cisplatin, or nab-paclitaxel). The doses identified in this study may be used in future trials to test whether the combination treatment is a safe and effective therapy for subjects with metastatic lung and/or pancreatic cancers.

Timeline

Start
2010-09-14
Primary completion
2013-10-07
Completion
2013-10-07

Outcome

Met primary endpoint

paper The primary end point of overall response rate (ORR) was met for both combinations. PMID 27876675 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Carboplatin Small molecule — —
Subject Cisplatin Other / unclassified — —
Subject Docetaxel Small molecule 75 mg/m2 —
Subject Erlotinib Small molecule — —
Subject Nab-paclitaxel Small molecule — —
Subject Pemetrexed Small molecule 500 mg/m2 —
Subject Trametinib Small molecule 1.5 mg —
Subject Trametinib Small molecule 2 mg —

Indications