CompletedPhase 2NCT01750281

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

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

Checked against the public recordLast updated Oct 24, 2023 · Source: ClinicalTrials.gov

StatusCompleted
PhasePhase 2
U.S. locations68
SponsorAstraZeneca
01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 2
Sponsor
AstraZeneca
Interventions being studied
Drug: Selumetinib 75 mg; Drug: Docetaxel 75 mg/m2; Drug: Docetaxel 60 mg/m2; Drug: Placebo
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

Who may be able to participate

Inclusion Criteria: * Provision of signed, written and dated informed consent prior to any study specific procedures * Male or female, aged 18 years or older * Histological or cytological confirmation of locally advanced or metastatic NSCLC (IIIB-IV) * Prospective confirmation of KRAS mutation negative status as determined via an AZ approved laboratory * Failure of 1st line anti-cancer therapy due to radiological documentation of disease progression in advanced disease or subsequent relapse of disease following 1st line therapy Exclusion Criteria: * Mixed small cell and non-small cell lung cancer histology * Received \>1 prior anti-cancer drug regimen for advanced or metastatic NSCLC. Patients who develop disease progression while on switch maintenance therapy (maintenance using an agent not in the first-line regimen) will not be eligible. * Other concomitant anti-cancer therapy agents except steroids * Prior treatment with a MEK (Mitogen-Activated Protein Kinase) inhibitor or any docetaxel-containing regimen (prior treatment with paclitaxel is acceptable) * The last radiation therapy within 4 weeks prior to starting study treatment, or limited field of radiation for palliation within 7 days of the first dose of study treatment.

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • Research SiteSanta Monica, California
  • Research SiteAurora, Colorado
  • Research SiteHollywood, Florida
  • Research SiteAtlanta, Georgia
  • Research SiteChicago, Illinois
  • Research SiteMarrero, Louisiana
  • Research SiteBoston, Massachusetts
  • Research SiteMineola, New York
  • Research SiteNew York, New York
  • Research SiteNew York, New York
  • Research SiteHershey, Pennsylvania
  • Research SitePhiladelphia, Pennsylvania

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Oct 24, 2023. Always confirm current availability with the study team.

View original record ↗