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

AstraZeneca32 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Colorectal Cancer

Interventions

AZD6244DRUG

50 or 75mg, capsules, PO, BID, 28 days

IrinotecanDRUG

180mg/m2, IV, Day 1\& 15 of each cycle

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (12)

Research Site

Los Angeles, California, United States

Research Site

Palm Springs, California, United States

Research Site

Aurora, Colorado, United States

Outcomes

Primary Outcomes

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

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 Outcomes

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

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

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

Data from ClinicalTrials.gov

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