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Study of Selumetinib (AZD6244)(ARRY-142886) in Combination With Irinotecan in Previously Treated Patients With Colorec

Sponsor
AstraZeneca (Industry)
Overall Status
Completed
CT.gov ID
NCT01116271
Collaborator
(none)
32
Enrollment
12
Locations
1
Arm
27
Duration (Months)
2.7
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to determine whether treatment with Selumetinib (AZD6244) (Hyd-Sulfate) in combination with Irinotecan as a second treatment in patients with K-ras or B-raf mutation will prevent tumor progression and prolong progression free survival.

Condition or Disease Intervention/Treatment Phase
Phase 2

Detailed Description

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

Study Design

Study Type:
Interventional
Actual Enrollment :
32 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
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
Study Start Date :
Apr 1, 2010
Actual Primary Completion Date :
Jul 1, 2012
Actual Study Completion Date :
Jul 1, 2012

Arms and Interventions

Arm Intervention/Treatment
Experimental: 1

Selumetinib (AZD6244) in combination with irinotecan

Drug: AZD6244
50 or 75mg, capsules, PO, BID, 28 days
Other Names:
  • Selumetinib

    • Drug: Irinotecan
    180mg/m2, IV, Day 1& 15 of each cycle
    Other Names:
  • Camptosar; Campto

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Dose Finding will be calculated based upon toxicity screening and dose modification guidelines within protocol. [AEs will be assessed at each cycle visit, discontinuation treatment visit, and 30 days post last day of study treatment]

    2. Objective Response Rate will be assessed by the RECIST guideline documented in the European Journal of Cancer, 2009. [Tumor evaluation via RECIST guidelines will be done on screening visit, day 22 of every other cycle, and treatment discontinuation visit]

    Secondary Outcome Measures

    1. Safety of combination of Selumetinib (AZD6244) with irinotecan by SAE and AE documentation [AEs will be assesed at the screening visit, each cycle visit, treatment discontinuation date, and 30 days post last day of study treatment]

    2. PK of Selumetinib (AZD6244), N-desmethyl Selumetinib(AZD6244) and selumetinib (AZD6244) amide in combination with irinotecan [PK sample draws will take place on Day 1 and 15 of first cycle]

    3. Progression Free Survival (PFS) for patients with K-ras or B-raf mutations treated with combination of irinotecan and Selumetinib (AZD6244) [PFS will be determined via the RECIST guidelines on tumor measurement done on day 22 of every other cycle and on the treatment discontinuation visit]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Research Site Los Angeles California United States
    2 Research Site Palm Springs California United States
    3 Research Site Aurora Colorado United States
    4 Research Site New Haven Connecticut United States
    5 Research Site Newark Delaware United States
    6 Research Site Miami Beach Florida United States
    7 Research Site New York New York United States
    8 Reserach Site Chapel Hill North Carolina United States
    9 Research Site Greenville North Carolina United States
    10 Research Site Washington North Carolina United States
    11 Research Site Philadelphia Pennsylvania United States
    12 Research Site Seattle Washington United States

    Sponsors and Collaborators

    • AstraZeneca

    Investigators

    • Principal Investigator: Howard Hochster, MD, Yale University
    • Principal Investigator: Lawrence Leichman, MD, Desert Regional Comprehensive Cancer Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    AstraZeneca
    ClinicalTrials.gov Identifier:
    NCT01116271
    Other Study ID Numbers:
    • D9010C00009
    • AGICC 09CRC02
    First Posted:
    May 4, 2010
    Last Update Posted:
    Jan 14, 2013
    Last Verified:
    Jan 1, 2013
    Keywords provided by AstraZeneca
    colorectal
    second line therapy
    K-ras or B-raf mutations
    response rate
    Progression Free Survival
    Additional relevant MeSH terms:
    Colorectal Neoplasms
    Irinotecan

    Study Results

    No Results Posted as of Jan 14, 2013