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: July 3, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention Phase
Non Small Cell Lung Cancer
Drug: AZD6244
Drug: docetaxel
Drug: Placebo
Phase 2

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

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 422
Study Start Date: April 2009
Estimated Study Completion Date: September 2014
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
AZD6244 in combination with docetaxel
Drug: AZD6244
oral capsules, 75mg twice daily
Drug: docetaxel
75mg/m2 iv on day 1 of every 21 day cycle
Other Name: Taxotere
Placebo Comparator: 2
Placebo in combination with docetaxel
Drug: docetaxel
75mg/m2 iv on day 1 of every 21 day cycle
Other Name: Taxotere
Drug: Placebo
placebo

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00890825

  Show 52 Study Locations
Sponsors and Collaborators
AstraZeneca
Investigators
Principal Investigator: Dr Pasi Janne Dana-Farber Cancer Institute, Boston, USA
Study Director: Dr Ian Smith AstraZeneca, Alderley Park, UK
  More Information

No publications provided by AstraZeneca

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00890825     History of Changes
Other Study ID Numbers: D1532C00016
Study First Received: April 29, 2009
Last Updated: July 3, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by AstraZeneca:
Non small cell lung cancer (NSCLC)
KRAS mutation

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Docetaxel
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 22, 2014