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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01116271
First received: April 30, 2010
Last updated: January 11, 2013
Last verified: January 2013
History of Changes

April 30, 2010
January 11, 2013
April 2010
July 2012   (final data collection date for primary outcome measure)
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: No ]
  • Dose Finding will be calculated based upon toxicity screening and dose modification guidelines within protocol. [ Time Frame: AEs will be assessed on the 1, 8, 15, 22 days of each cycle, discontinuation treatment visit, and 30 days post last day of study treatment. ] [ Designated as safety issue: Yes ]
  • 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 each cycle, and treatment discontinuation visit. ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01116271 on ClinicalTrials.gov Archive Site
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Safety of combination of Selumetinib (AZD6244) with irinotecan by SAE and AE documentation [ Time Frame: AEs will be assesed at the screening visit, first day of each cycle, treatment discontinuation date, and 30 days post last day of study treatment. ] [ Designated as safety issue: Yes ]
  • 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 each cycle. ] [ Designated as safety issue: No ]
  • 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 each cycle and on the treatment discontinuation visit. ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Study of Selumetinib (AZD6244)(ARRY-142886) in Combination With Irinotecan in Previously Treated Patients With Colorec
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

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.

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
Interventional
Phase 2
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Colorectal Cancer
  • Drug: AZD6244
    50 or 75mg, capsules, PO, BID, 28 days
    Other Name: Selumetinib
  • Drug: Irinotecan
    180mg/m2, IV, Day 1& 15 of each cycle
    Other Name: Camptosar; Campto
Experimental: 1
Selumetinib (AZD6244) in combination with irinotecan
Interventions:
  • Drug: AZD6244
  • Drug: Irinotecan
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
32
July 2012
July 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01116271
D9010C00009, AGICC 09CRC02
Not Provided
AstraZeneca
AstraZeneca
Not Provided
Principal Investigator: Howard Hochster, MD Yale University
Principal Investigator: Lawrence Leichman, MD Desert Regional Comprehensive Cancer Center
AstraZeneca
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP