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
  Purpose

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 Intervention Phase
Colorectal Cancer
Drug: AZD6244
Drug: Irinotecan
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 32
Study Start Date: April 2010
Study Completion Date: July 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Selumetinib (AZD6244) in combination with irinotecan
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

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01116271

Locations
United States, California
Research Site
Los Angeles, California, United States
Research Site
Palm Springs, California, United States
United States, Colorado
Research Site
Aurora, Colorado, United States
United States, Connecticut
Research Site
New Haven, Connecticut, United States
United States, Delaware
Research Site
Newark, Delaware, United States
United States, Florida
Research Site
Miami Beach, Florida, United States
United States, New York
Research Site
New York, New York, United States
United States, North Carolina
Reserach Site
Chapel Hill, North Carolina, United States
Research Site
Greenville, North Carolina, United States
Research Site
Washington, North Carolina, United States
United States, Pennsylvania
Research Site
Philadelphia, Pennsylvania, United States
United States, Washington
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
  More Information

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01116271     History of Changes
Other Study ID Numbers: D9010C00009, AGICC 09CRC02
Study First Received: April 30, 2010
Last Updated: January 11, 2013
Health Authority: United States: Food and Drug Administration

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
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Irinotecan
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 22, 2014