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Assess Efficacy and Safety of AZD6244 in Combination With Docetaxel in Patients Receiving Second Line Non Small Cell Lung Cancer Treatment.

NCT01750281 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 212

Last updated 2023-10-24

Study results available
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Summary

The purpose of this study is to treat patients with locally advanced or metastatic NSCLC with a combination therapy of selumetinib and two different doses of docetaxel 75mg/m2 or 60 mg/m2 vs placebo and compare how well each dose affects how their cancer responds. It will also help us to understand the tolerability profile of the different dosing regimens in these patients

Conditions

  • Locally Advanced or Metastatic Non Small Cell Lung Cancer Stage IIIb - IV

Interventions

DRUG

Selumetinib 75 mg

Three selumetinib capsules (Hyd-Sulfate) 25 mg will be administered orally, twice daily, (75 mg dose bd) on an uninterrupted schedule.

DRUG

Docetaxel 75 mg/m2

Docetaxel 75 mg/m2 will be administered intravenously on day 1 of each 21 day cycle.

DRUG

Docetaxel 60 mg/m2

Docetaxel 60 mg/m2 will be administered intravenously on day 1 of each 21 day cycle.

DRUG

Placebo

Three placebo capsules will be administered orally uninterrupted twice daily.

Sponsors & Collaborators

Principal Investigators

  • Gabriella Mariani, MD · AstraZeneca UK, MSD

  • Pasi Janne, MD · Dana-Farber Cancer Institute, USA

  • Jean-Charles Soria, MD · Institut de Cancerology Gustave Roussy, France

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
2012-12-18
Primary Completion
2016-01-27
Completion
2022-10-31

Countries

  • United States
  • Brazil
  • Bulgaria
  • France
  • Germany
  • Hungary
  • Netherlands
  • Poland

Study Locations

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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 NCT01750281 on ClinicalTrials.gov