AZD6244 in combination with docetaxel versus docetaxel alone in KRAS mutation positive NSCLC patients

Study identifier:D1532C00016

ClinicalTrials.gov identifier:NCT00890825

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

Phase II, Double-Blind, Randomised, Placebo-Controlled Study to Assess the Efficacy of AZD6244 in Combination With Docetaxel, Compared With Docetaxel Alone, in 2nd Line Patients With KRAS Mutation Positive Locally Advanced Metastatic NSCLC

Medical condition

Non Small Cell Lung Cancer

Phase

Phase 2

Healthy volunteers

Study drug

AZD6244, docetaxel, Placebo

Sex

All

Actual Enrollment

Study type

Interventional

Age

18 Years - 130 Years

Date

Study Start Date: 20 Apr 2009

Primary Completion Date: 11 May 2011

Study Completion Date: 02 Nov 2016

Study design

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment

Verification:

Verified 01 May 2018 by AstraZeneca

Collaborators

Inclusion and exclusion criteria

The primary objective of this study was to assess the efficacy in terms of overall survival (OS) of AZD6244 in combination with docetaxel, compared with docetaxel alone, in second-line patients with KRAS mutation-positive locally advanced or metastatic NSCLC. Amendment 4 of the CSP altered the primary objective and outcome variable from progression-free survival (PFS) to OS, and the secondary outcome variable changed from OS to PFS. The secondary objectives of the study were: • To further assess the efficacy of AZD6244 in combination with docetaxel, compared with docetaxel alone, in second-line patients with KRAS mutation-positive locally advanced or metastatic NSCLC • To assess the safety and tolerability profile of AZD6244 in combination with docetaxel • To investigate the use of plasma and serum as a potential source of circulating free tumour DNA (cfDNA) for the analysis of KRAS mutation status • To investigate the PK of AZD6244 and N-desmethyl AZD6244 and any other known metabolites when AZD6244 is administered in combination with docetaxel. The exploratory objectives of the study were: • To assess the prevalence, severity and change over time of advanced NSCLC cancer specific symptoms in patients receiving AZD6244 in combination with docetaxel and docetaxel alone • To explore potential biomarkers in residual tumour, plasma and/or serum taken for KRAS mutational analysis which may influence development of NSCLC (and associated clinical characteristics) and/or response (optional) • To investigate the relationship between AZD6244 and/or N-desmethyl AZD6244 and any other known metabolite plasma concentrations or exposure and clinical outcomes, efficacy, AEs, and/or safety parameters if deemed appropriate • To collect and store deoxyribonucleic acid (DNA), derived from a blood sample, for future exploratory research into genes that may influence response, eg, distribution, safety, tolerability, and efficacy of AZD6244 and/or agents used in combination and/or as comparators (optional).

No locations available

Arms	Assigned Interventions
Active Comparator: AZD6244 + Docetaxel AZD6244 75 mg bd + Docetaxel 75 mg/m^2	Drug: AZD6244 oral capsules, 75mg twice daily Other Name: Selumetinib Drug: docetaxel 75mg/m2 iv on day 1 of every 21 day cycle Other Name: Taxotere
Placebo Comparator: Placebo + Docetaxel Placebo + Docetaxel 75 mg/m^2	Drug: docetaxel 75mg/m2 iv on day 1 of every 21 day cycle Other Name: Taxotere Drug: Placebo placebo Other Name: Placebo

Documents available

Cancer Study Locator (For US and Canada sites only)
Download
Trial Results Summaries
Available here

Contacts

Contact

AstraZeneca Clinical Study Information Center

1-877-240-9479

[email protected]

Contact Backup

AstraZeneca Locator Service

877-400-4656

[email protected]

Investigators

Principal Investigator

Dr. Pasi Janne

Dana-Farber Cancer Institute, Boston, USA