Comparison of AZD6244 in Combination With Docetaxel Versus Docetaxel Alone in KRAS Mutation Positive Non Small Cell Lung Cancer (NSCLC) Patients

This study is ongoing, but not recruiting participants.

Sponsor:

Information provided by (Responsible Party):

AstraZeneca

ClinicalTrials.gov Identifier:

NCT00890825

First received: April 29, 2009

Last updated: March 19, 2013

Last verified: March 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

April 29, 2009

Last Updated Date

March 19, 2013

Start Date ^ICMJE

April 2009

Primary Completion Date

May 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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. ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

To assess the efficacy in terms of Progression Free Survival (PFS) 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: PFS 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 ] [ Designated as safety issue: No ]

Change History

Complete list of historical versions of study NCT00890825 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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. ] [ Designated as safety issue: No ]
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) ] [ Designated as safety issue: Yes ]
To investigate the pharmacokinetics of AZD6244 [ Time Frame: At Day 1 and Day 22 ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

To further assess the efficacy in terms of:- Overall Survival (OS)- 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: 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 ] [ Designated as safety issue: No ]
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) ] [ Designated as safety issue: Yes ]
To investigate the pharmacokinetics of AZD6244 [ Time Frame: At Day 1 and Day 22 ] [ Designated as safety issue: No ]

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Comparison of AZD6244 in Combination With Docetaxel Versus Docetaxel Alone in KRAS Mutation Positive Non Small Cell Lung Cancer (NSCLC) Patients

Official Title ^ICMJE

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)

Brief 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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Condition ^ICMJE

Non Small Cell Lung Cancer

Intervention ^ICMJE

Drug: AZD6244
oral capsules, 75mg twice daily
Drug: docetaxel
75mg/m2 iv on day 1 of every 21 day cycle

Other Name: Taxotere
Drug: Placebo
placebo

Study Arm (s)

Active Comparator: 1
AZD6244 in combination with docetaxel
Interventions:
- Drug: AZD6244
- Drug: docetaxel
Placebo Comparator: 2
Placebo in combination with docetaxel
Interventions:
- Drug: docetaxel
- Drug: Placebo

Publications *

Jänne PA, Shaw AT, Pereira JR, Jeannin G, Vansteenkiste J, Barrios C, Franke FA, Grinsted L, Zazulina V, Smith P, Smith I, Crinò L. Selumetinib plus docetaxel for KRAS-mutant advanced non-small-cell lung cancer: a randomised, multicentre, placebo-controlled, phase 2 study. Lancet Oncol. 2013 Jan;14(1):38-47. doi: 10.1016/S1470-2045(12)70489-8. Epub 2012 Nov 28.

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Enrollment ^ICMJE

Estimated Completion Date

June 2013

Primary Completion Date

May 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States, Belgium, Brazil, Bulgaria, Canada, Czech Republic, France, Hungary, Italy, Mexico, Peru, Spain

Administrative Information

NCT Number ^ICMJE

NCT00890825

Other Study ID Numbers ^ICMJE

D1532C00016

Has Data Monitoring Committee

Not Provided

Responsible Party

AstraZeneca

Study Sponsor ^ICMJE

AstraZeneca

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:	Dr Pasi Janne	Dana-Farber Cancer Institute, Boston, USA
Study Director:	Dr Ian Smith	AstraZeneca, Alderley Park, UK

Information Provided By

AstraZeneca

Verification Date

March 2013

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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