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AZD6244 in Combination With Docetaxel Versus Docetaxel Alone in KRAS Mutation Positive NSCLC Patients

NCT00890825 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 88

Last updated 2018-06-20

Study results available
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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.

Conditions

  • Non Small Cell Lung Cancer

Interventions

DRUG

AZD6244

oral capsules, 75mg twice daily

DRUG

docetaxel

75mg/m2 iv on day 1 of every 21 day cycle

DRUG

Placebo

placebo

Sponsors & Collaborators

Principal Investigators

  • Dr. Pasi Janne · Dana-Farber Cancer Institute, Boston, USA

  • Dr. Gabriella Mariani · AstraZeneca, Hertfordshire, UK

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
130 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-04-20
Primary Completion
2011-05-11
Completion
2016-11-02

Countries

  • United States
  • Belgium
  • Brazil
  • Bulgaria
  • Canada
  • Czechia
  • France
  • Hungary
  • Italy
  • Mexico
  • Peru
  • Spain

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00890825 on ClinicalTrials.gov