Back to resultsStudy of Selumetinib (AZD6244)(ARRY-142886) in Combination With Irinotecan in Previously Treated Patients With Colorec
Primary Purpose
Colorectal Cancer
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
AZD6244
Irinotecan
Sponsored by
About this trial
This is an interventional treatment trial for Colorectal Cancer focused on measuring colorectal, second line therapy, K-ras or B-raf mutations, response rate, Progression Free Survival
Eligibility Criteria
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
Sites / Locations
- Research Site
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- Reserach Site
- Research Site
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Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1
Arm Description
Selumetinib (AZD6244) in combination with irinotecan
Outcomes
Primary Outcome Measures
Dose Finding will be calculated based upon toxicity screening and dose modification guidelines within protocol.
Objective Response Rate will be assessed by the RECIST guideline documented in the European Journal of Cancer, 2009.
Secondary Outcome Measures
Safety of combination of Selumetinib (AZD6244) with irinotecan by SAE and AE documentation
PK of Selumetinib (AZD6244), N-desmethyl Selumetinib(AZD6244) and selumetinib (AZD6244) amide in combination with irinotecan
Progression Free Survival (PFS) for patients with K-ras or B-raf mutations treated with combination of irinotecan and Selumetinib (AZD6244)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01116271
Brief Title
Study of Selumetinib (AZD6244)(ARRY-142886) in Combination With Irinotecan in Previously Treated Patients With Colorec
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 Type
Interventional
2. Study Status
Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
April 2010 (undefined)
Primary Completion Date
July 2012 (Actual)
Study Completion Date
July 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AstraZeneca
4. Oversight
5. 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.
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
Keywords
colorectal, second line therapy, K-ras or B-raf mutations, response rate, Progression Free Survival
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
32 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Selumetinib (AZD6244) in combination with irinotecan
Intervention Type
Drug
Intervention Name(s)
AZD6244
Other Intervention Name(s)
Selumetinib
Intervention Description
50 or 75mg, capsules, PO, BID, 28 days
Intervention Type
Drug
Intervention Name(s)
Irinotecan
Other Intervention Name(s)
Camptosar; Campto
Intervention Description
180mg/m2, IV, Day 1& 15 of each cycle
Primary Outcome Measure Information:
Title
Dose Finding will be calculated based upon toxicity screening and dose modification guidelines within protocol.
Time Frame
AEs will be assessed at each cycle visit, discontinuation treatment visit, and 30 days post last day of study treatment
Title
Objective Response Rate will be assessed by the RECIST guideline documented in the European Journal of Cancer, 2009.
Time Frame
Tumor evaluation via RECIST guidelines will be done on screening visit, day 22 of every other cycle, and treatment discontinuation visit
Secondary Outcome Measure Information:
Title
Safety of combination of Selumetinib (AZD6244) with irinotecan by SAE and AE documentation
Time Frame
AEs will be assesed at the screening visit, each cycle visit, treatment discontinuation date, and 30 days post last day of study treatment
Title
PK of Selumetinib (AZD6244), N-desmethyl Selumetinib(AZD6244) and selumetinib (AZD6244) amide in combination with irinotecan
Time Frame
PK sample draws will take place on Day 1 and 15 of first cycle
Title
Progression Free Survival (PFS) for patients with K-ras or B-raf mutations treated with combination of irinotecan and Selumetinib (AZD6244)
Time Frame
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Howard Hochster, MD
Organizational Affiliation
Yale University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Lawrence Leichman, MD
Organizational Affiliation
Desert Regional Comprehensive Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Research Site
City
Los Angeles
State/Province
California
Country
United States
Facility Name
Research Site
City
Palm Springs
State/Province
California
Country
United States
Facility Name
Research Site
City
Aurora
State/Province
Colorado
Country
United States
Facility Name
Research Site
City
New Haven
State/Province
Connecticut
Country
United States
Facility Name
Research Site
City
Newark
State/Province
Delaware
Country
United States
Facility Name
Research Site
City
Miami Beach
State/Province
Florida
Country
United States
Facility Name
Research Site
City
New York
State/Province
New York
Country
United States
Facility Name
Reserach Site
City
Chapel Hill
State/Province
North Carolina
Country
United States
Facility Name
Research Site
City
Greenville
State/Province
North Carolina
Country
United States
Facility Name
Research Site
City
Washington
State/Province
North Carolina
Country
United States
Facility Name
Research Site
City
Philadelphia
State/Province
Pennsylvania
Country
United States
Facility Name
Research Site
City
Seattle
State/Province
Washington
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Study of Selumetinib (AZD6244)(ARRY-142886) in Combination With Irinotecan in Previously Treated Patients With Colorec
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