Assess Efficacy and Safety of AZD6244 in Combination with Docetaxel in Patients receiving second line Non Small Cell Lung Cancer treatment. - SELECT-2
Study identifier:D1532C00064
ClinicalTrials.gov identifier:NCT01750281
EudraCT identifier:2012-003622-25
CTIS identifier:N/A
Study Complete
Official Title
A Phase II, Double-Blind, Randomised, Placebo-Controlled Study to Assess the Efficacy and Safety of Selumetinib (AZD6244; ARRY-142886) (Hyd-Sulfate) in Combination with Docetaxel, Compared with Placebo in Combination with Docetaxel, in Patients receiving second line treatment for Locally Advanced or Metastatic Non Small Cell Lung Cancer (Stage IIIB - IV)
Medical condition
Locally Advanced or Metastatic Non Small Cell Lung Cancer stage IIIb - IV
Phase
Phase 2
Healthy volunteers
No
Study drug
Selumetinib 75 mg, Docetaxel 75 mg/m2, Docetaxel 60 mg/m2, Placebo
Sex
All
Actual Enrollment
212
Study type
Interventional
Age
18 Years - 130 Years
Date
Study Start Date: 18 Dec 2012
Primary Completion Date: 27 Jan 2016
Study Completion Date: 31 Oct 2022
Study design
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment
Verification:
Verified 01 Oct 2023 by AstraZeneca
Sponsors
AstraZeneca
Collaborators
-
Inclusion and exclusion criteria
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No locations available
| Arms | Assigned Interventions |
|---|---|
| Experimental: Selumetinib 75 mg twice daily +Docetaxel 75 mg/m2 Selumetinib capsules will be administered orally uninterrupted twice daily in combination with docetaxel 75 mg/m2 intravenously administered on day 1 of each 21 day cycle. | Drug: Selumetinib 75 mg Three selumetinib capsules (Hyd-Sulfate) 25 mg will be administered orally, twice daily, (75 mg dose bd) on an uninterrupted schedule. Drug: Docetaxel 75 mg/m2 Docetaxel 75 mg/m2 will be administered intravenously on day 1 of each 21 day cycle. |
| Experimental: Selumetinib 75 mg twice daily + Docetaxel 60 mg/m2 Selumetinib capsules will be administered orally uninterrupted twice daily in combination with docetaxel 60 mg/m2 intravenously administered on day 1 of each 21 day cycle. | Drug: Selumetinib 75 mg Three selumetinib capsules (Hyd-Sulfate) 25 mg will be administered orally, twice daily, (75 mg dose bd) on an uninterrupted schedule. Drug: Docetaxel 60 mg/m2 Docetaxel 60 mg/m2 will be administered intravenously on day 1 of each 21 day cycle. |
| Experimental: Placebo twice daily + Docetaxel 75 mg/m2 Three placebo capsules will be administered orally uninterrupted twice daily in combination with docetaxel 75 mg/m2 intravenously administered on day 1 of each 21 day cycle. | Drug: Docetaxel 75 mg/m2 Docetaxel 75 mg/m2 will be administered intravenously on day 1 of each 21 day cycle. Drug: Placebo Three placebo capsules will be administered orally uninterrupted twice daily. |
Contacts
Investigators
Principal Investigator
Gabriella Mariani
AstraZeneca UK, MSD
