Overview

This trial has been completed.

Condition non small cell lung cancer
Treatments azd6244, docetaxel, placebo
Phase phase 2
Target MEK
Sponsor AstraZeneca
Start date April 2009
End date May 2011
Trial size 422 participants
Trial identifier NCT00890825, D1532C00016

Summary

The purpose of this study is to compare the efficacy of AZD6244 in combination with docetaxel versus docetaxel alone in patients with KRAS mutation positive locally advanced or metastatic non small cell lung cancer.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Active Comparator)
AZD6244 in combination with docetaxel
azd6244
oral capsules, 75mg twice daily
docetaxel Taxotere
75mg/m2 iv on day 1 of every 21 day cycle
(Placebo Comparator)
Placebo in combination with docetaxel
docetaxel Taxotere
75mg/m2 iv on day 1 of every 21 day cycle
placebo
placebo

Primary Outcomes

Measure
To assess the efficacy in terms of Overall Survival (OS) of AZD6244 in combination with docetaxel compared with docetaxel alone, in 2nd line patients with KRAS mutation positive locally advanced or metastatic non small cell lung cancer
time frame: Time Frame: Overall survival calculated as the interval from date of randomisation to date of patient death (any cause). Patients who have not died at final analysis, or who withdraw consent, will be censored at last date they were known to be alive.

Secondary Outcomes

Measure
To further assess the efficacy in terms of:- Progression Free Survival (PFS) -Objective Response Rate (ORR)- Duration of Response (DoR)- Change in tumour size at 12 weeks- Alive and Progression Free at 6 months (APF6)
time frame: PFS, ORR, DoR, APF6 and change in tumour size at 12 weeks will be assessed using RECIST measurements. RECIST assessments to be carried out at baseline, week 6, week 12 and every 12 weeks thereafter relative to randomisation.
To assess the safety and tolerability profile of AZD6244 in combination with docetaxel
time frame: At every visit (ie weekly for the first 6 weeks and then every 3 weeks)
To investigate the pharmacokinetics of AZD6244
time frame: At Day 1 and Day 22

Eligibility Criteria

Male or female participants from 18 years up to 130 years old.

Inclusion Criteria: - Locally advanced or metastatic non small cell lung cancer (IIIB-IV) - Failure of first line anti-cancer therapy (either radiological documentation of disease progression or due to toxicity) in advanced disease or subsequent relapse of disease following first line therapy - Tumour sample confirmed as KRAS mutation positive (Note: Sample must be available upon enrolment to ship to AZ appointed central laboratory, or mutation status confirmed locally at AstraZeneca agreed local laboratory using agreed methodology, or mutation status confirmed by an accredited (eg CLIA certified) commercial laboratory (eg Genzyme or Lab 21). Exclusion Criteria: - Received >1 prior anti-cancer therapy for advanced or metastatic non small cell lung cancer (excluding radiotherapy) - Prior treatment with a MEK inhibitor or any docetaxel containing regimen (prior treatment with paclitaxel is acceptable) - Having received an investigational drug within 30 days of starting treatment, or have not recovered from side effects of an investigational drug - Brain metastases or spinal cord compression unless asymptomatic, treated and stable off steroids and anti-convulsants for at least 1 month

Additional Information

Official title A Phase II, Double-Blind, Randomised, Placebo-Controlled Study to Assess the Efficacy of AZD6244 (Hyd-Sulfate) in Combination With Docetaxel, Compared With Docetaxel Alone, in 2nd Line Patients With KRAS Mutation Positive Locally Advanced Metastatic Non Small Cell Lung Cancer (Stage IIIB- IV)
Principal investigator Dr Pasi Janne
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by AstraZeneca.