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

Colorectal Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01116271
• Other study ID #: D9010C00009
• Secondary ID: AGICC 09CRC02
• Status: Completed
• Phase: Phase 2
• First received: April 30, 2010
• Last updated: January 11, 2013
• Start date: April 2010
• Est. completion date: July 2012

Study information

• Verified date: January 2013
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: July 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Drug:
• AZD6244
50 or 75mg, capsules, PO, BID, 28 days
• Irinotecan
180mg/m2, IV, Day 1& 15 of each cycle

Locations

Country	Name	City	State
United States	Research Site	Aurora	Colorado
United States	Reserach Site	Chapel Hill	North Carolina
United States	Research Site	Greenville	North Carolina
United States	Research Site	Los Angeles	California
United States	Research Site	Miami Beach	Florida
United States	Research Site	New Haven	Connecticut
United States	Research Site	New York	New York
United States	Research Site	Newark	Delaware
United States	Research Site	Palm Springs	California
United States	Research Site	Philadelphia	Pennsylvania
United States	Research Site	Seattle	Washington
United States	Research Site	Washington	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Primary	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	No
Secondary	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	Yes
Secondary	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	No
Secondary	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	No

External Links

•   Cancer Study Locator (US and Canada only)