drugset / Trial / NCT01809210
Assess Safety & Efficacy of Selumetinib When Given in Combination With Standard First Line Treatment for Advanced Non-small Cell Lung Cancer
NaSingle-groupOpen-labelTreatment
Summary
This is a Phase I, open label multicentre study of selumetinib administered orally in combination with first line chemotherapy regimens to patients with advanced/metastatic NSCLC. The study has been designed to allow an investigation of the optimal dose of selumetinib in combination with various standard first line double-platinum chemotherapy regimens. Initial assessment will be based on tolerability of selumetinib in combination with one or more selected regimens that are considered to be tolerated also being assessed for preliminary evidence of activity. This study is a dose finding and optional cohort expansion; In addition all patients will be assessed for anti-cancer efficacy of the combination of selumetinib and chemotherapy.
Timeline
- Start
- 2013-04-04
- Primary completion
- 2016-01-04
- Completion
- 2016-01-04
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Carboplatin | Small molecule | 5 unknown | Intravenous |
| Subject | Cisplatin | Other / unclassified | 25 mg/m2 | Intravenous |
| Subject | Cisplatin | Other / unclassified | 50 mg/m2 | Intravenous |
| Subject | Cisplatin | Other / unclassified | 75 mg/m2 | Intravenous |
| Subject | Gemcitabine | Small molecule | 1000 mg/m2 | Intravenous |
| Subject | Gemcitabine | Small molecule | 1250 mg/m2 | Intravenous |
| Subject | Pemetrexed | Small molecule | 500 mg/m2 | Intravenous |
| Subject | Selumetinib | Small molecule | 50 mg | Oral |
| Subject | Selumetinib | Small molecule | 75 mg | Oral |