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A Dose Finding and Phase II Study of Selumetinib (AZD6244) (Hyd-Sulfate) in Combination With Irinotecan, in 2nd Line Patients With K-ras or B-raf Mutation Positive Advanced or Metastatic Colorectal Cancer


Phase 2
18 Years
N/A
Not Enrolling
Both
Colorectal Cancer

Thank you

Trial Information

A Dose Finding and Phase II Study of Selumetinib (AZD6244) (Hyd-Sulfate) in Combination With Irinotecan, in 2nd Line Patients With K-ras or B-raf Mutation Positive Advanced or Metastatic Colorectal Cancer


A Dose Finding and Phase II Study of Selumetinib (AZD6244) (Hyd-Sulfate) in Combination
with Irinotecan, in 2nd Line Patients with K-ras or B-raf Mutation Positive Advanced or
Metastatic Colorectal Cancer


Inclusion Criteria:



- Histological or cytological confirmation of advanced or metastatic colorectal cancer
with available tissue and tumor sample confirmed as K-ras or B-raf mutation positive.
Current failure of 1st line anti-cancer therapy with an oxaliplatin and bevacizumab based
regimen or patients relapsing within 12 months of completing adjuvant FOLFOX .

Exclusion Criteria:

- Treatment within 14 days prior to first study treatment with conventional therapy or
treatment within 28 days prior to first study treatment with an investigational drug Prior
treatment with a MEK or B-raf inhibitor or any irinotecan-containing regimen Prior
treatment with a MEK or B-raf inhibitor or any irinotecan-containing regimen

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Dose Finding will be calculated based upon toxicity screening and dose modification guidelines within protocol.

Outcome Time Frame:

AEs will be assessed at each cycle visit, discontinuation treatment visit, and 30 days post last day of study treatment

Safety Issue:

Yes

Principal Investigator

Howard Hochster, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Yale University

Authority:

United States: Food and Drug Administration

Study ID:

D9010C00009

NCT ID:

NCT01116271

Start Date:

April 2010

Completion Date:

July 2012

Related Keywords:

  • Colorectal Cancer
  • colorectal
  • second line therapy
  • K-ras or B-raf mutations
  • response rate
  • Progression Free Survival
  • Colorectal Neoplasms

Name

Location
Research Site Anaheim, California  
Research Site Boulder, Colorado  
Research Site Danbury, Connecticut  
Research Site Lewes, Delaware  
Research Site Boca Raton, Florida  
Research Site Albany, New York  
Research Site Asheville, North Carolina  
Research Site Allentown, Pennsylvania  
Research Site Auburn, Washington  
Reserach Site Durham, North Carolina