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Brief Title: Study of Selumetinib in Patients With Previously Treated or Untreated Advanced/Metastatic NSCLC
Official Title: A Phase Ib Study of Selumetinib in Patients With Previously Treated or Untreated Advanced/Metastatic NSCLC Who Are Receiving Standard Chemotherapy Regimens.
Study ID: NCT01783197
Brief 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.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
BCCA - Vancouver Cancer Centre, Vancouver, British Columbia, Canada
Juravinski Cancer Centre at Hamilton Health Sciences, Hamilton, Ontario, Canada
Cancer Centre of Southeastern Ontario at Kingston, Kingston, Ontario, Canada
Ottawa Hospital Research Institute, Ottawa, Ontario, Canada
Name: Garth Nicholas
Affiliation: Ottawa Health Research Institute - General Division
Role: STUDY_CHAIR
Name: John Goffin
Affiliation: Juravinski Cancer Centre at Hamilton Health Sciences
Role: STUDY_CHAIR