NCT01783197

Study of Selumetinib in Patients With Previously Treated or Untreated Advanced/Metastatic NSCLC

A Phase Ib Study of Selumetinib in Patients With Previously Treated or Untreated Advanced/Metastatic NSCLC Who Are Receiving Standard Chemotherapy Regimens.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 39 (actual)
• Sponsor: Canadian Cancer Trials Group · Network
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This research is being done because further research on selumetinib in combination with standard chemotherapy treatment is needed. Although the number of treatment options for patients with advanced non-small cell lung cancer has increased over the past decade, prognosis remains poor, and there is a need for additional therapeutic options.

Detailed description

The purpose of this study is to find the highest dose of a new drug, selumetinib, given in combination with standard chemotherapies, that can be tolerated without causing very severe side effects. This is done by starting at a dose lower than the one that does not cause side effects in animals. Participants are given selumetinib and are watched very closely to see what side effects they have and to make sure the side effects are not severe. If the side effects are not severe, then more potential participants are asked to join this study and are given a higher dose of selumetinib. Participants joining this study later on will take selumetinib at higher doses, take doses twice daily or take for more days in a 21 day period than participants who join earlier. This will continue until a dose is found that causes severe but temporary side effects. Doses higher than that will not be given.

Conditions

• Non Small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	Paclitaxel
DRUG	Carboplatin
DRUG	Selumetinib
DRUG	Pemetrexed
DRUG	Cisplatin

Timeline

• Start date: 2013-06-04
• Primary completion: 2017-04-18
• Completion: 2019-04-02
• First posted: 2013-02-04
• Last updated: 2023-08-04

Locations

4 sites across 1 country: Canada