Assess Efficacy & Safety of Selumetinib in Combination with Docetaxel in Patients receiving 2nd line treatment for v-Ki-ras2 Kirsten rat sarcoma viral oncogene homolog (KRAS) positive NSCLC - SELECT-1
Study identifier:D1532C00079
ClinicalTrials.gov identifier:NCT01933932
EudraCT identifier:2013-001676-38
CTIS identifier:N/A
Recruitment Complete
Official Title
A Phase III, Double-Blind, Randomised, Placebo-Controlled Study to Assess the Efficacy and Safety of Selumetinib (AZD6244; ARRY-142886) (Hyd-Sulfate) in Combination with Docetaxel, in Patients receiving second line treatment for KRAS Mutation-Positive Locally Advanced or Metastatic Non Small Cell Lung Cancer (Stage IIIB – IV) (SELECT 1)
Medical condition
Locally Advanced or Metastatic Non Small Cell Lung Cancer stage IIIb - IV
Phase
Phase 3
Healthy volunteers
No
Study drug
Selumetinib, Docetaxel, Placebo, Pegylated G-CSF
Sex
All
Actual Enrollment
510
Study type
Interventional
Age
18 Years - 130 Years
Date
Study Start Date: 25 Sept 2013
Primary Completion Date: 07 Jun 2016
Estimated Study Completion Date: 29 Dec 2023
Study design
Allocation: Randomized
Endpoint Classification: Safety/Efficacy 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 + Docetaxel Three 25mg 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 Three 25 mg selumetinib capsules (Hyd-Sulfate) be administered orally, twice daily, (total dose 75 mg dose bd) on an uninterrupted schedule. Other Name: AZD6244; ARRY-142886 Drug: Docetaxel Docetaxel 75 mg/m2 will be administered intravenously on day 1 of each 21 day cycle. Drug: Pegylated G-CSF All patients will receive pegylated Granulocyte Colony Stimulating Factor (G-CSF) at least 24 hours after administration of every docetaxel dose and not within 14 days prior to the next docetaxel administration. Other Name: Pegfilgrastim 6 mg |
| Experimental: Placebo + Docetaxel 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 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 in combination with docetaxel 75 mg/m2 intravenously administered on day 1 of each 21 day cycle. Drug: Pegylated G-CSF All patients will receive pegylated Granulocyte Colony Stimulating Factor (G-CSF) at least 24 hours after administration of every docetaxel dose and not within 14 days prior to the next docetaxel administration. Other Name: Pegfilgrastim 6 mg |
Contacts
Investigators
Principal Investigator
Gabriella Mariani
AstraZeneca UK, MSD
