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

Part of paid clinical trials in Los Angeles, California.

Sponsor
AstraZeneca
Study ID
NCT01116271
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Apr 30, 2010
Status verified
Jan 2013
Primary completion
Jul 31, 2012
Completion
Jul 31, 2012

Study Design

Enrollment
32 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: 1
    Selumetinib (AZD6244) in combination with irinotecan

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 ]

Locations (12)

FacilityCityStateZIPSite coordinators
Research SiteLos AngelesCalifornia--
Research SitePalm SpringsCalifornia--
Research SiteAuroraColorado--
Research SiteNew HavenConnecticut--
Research SiteNewarkDelaware--
Research SiteMiami BeachFlorida--
Research SiteNew YorkNew York--
Reserach SiteChapel HillNorth Carolina--
Research SiteGreenvilleNorth Carolina--
Research SiteWashingtonNorth Carolina--
Research SitePhiladelphiaPennsylvania--
Research SiteSeattleWashington--

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