Phase I/II Study of KRN330 Plus Irinotecan in Patients With Metastatic Colorectal Cancer

Part of paid clinical trials in Huntsville, Alabama.

Sponsor
Kyowa Kirin Co., Ltd.
Study ID
NCT00838578
Phase
PHASE1/PHASE2
Status
Terminated

Conditions

Eligibility Criteria

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

Interventions

  • KRN330 — BIOLOGICAL
    KRN330 will be dosed at 0.5 mg/kg weekly until disease progression.
  • Irinotecan — DRUG
    Irinotecan will be dosed at 180 mg/m2 biweekly until disease progression.

Study Details

The primary objective of the Phase II portion of this study is to assess the efficacy of KRN330 in combination with irinotecan after first-line or adjuvant FOLFOX (5-fluorouracil, leucovorin, and oxaliplatin)/CapOx (capecitabine and oxaliplatin) treatment failure in patients with metastatic colorectal cancer.

Key Dates

Start date
Mar 31, 2009
Status verified
Apr 2024
Primary completion
Jul 31, 2012
Completion
Oct 31, 2012

Study Design

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

Arms

  • Experimental: KRN330 + Irinotecan
    open label, single arm

Primary Outcome Measure

Number of Participants With Serious and Other (Non-Serious) Adverse Events According to the CTCAE v.3.0 [ Time Frame: Until disease progression, death, or withdrawal post initial KRN330 treatment, assessed up to 100 months ]

Locations (12)

FacilityCityStateZIPSite coordinators
Clearview Cancer InstituteHuntsvilleAlabama35805-
Arizona Clinical Research CenterTucsonArizona85715-
USC/Norris Comprehensive Cancer CenterLos AngelesCalifornia90033-
Lombardi Comprehensive Cancer Center, Georgetown University HospitalWashington D.C.District of Columbia20007-2113-
Florida Cancer SpecialistsFort MyersFlorida33916-
University of Florida COllege of Medicine/Shands Cancer CenterGainesvilleFlorida32610-
University of Miami - Sylvester Comprehensive Cancer CenterMiamiFlorida33136-
Emory University - Winship Cancer InstituteAtlantaGeorgia30322-
Greater Baltimore Medical CenterBaltimoreMaryland21204-
NYU Clinical Trials Office, New York University Cancer InstituteNew YorkNew York10016-
Sarah Cannon Research InstituteNashvilleTennessee37203-
Vanderbilt University Medical CenterNashvilleTennessee37232-

Find similar trials in Huntsville, AL

By condition
Colorectal cancer
By specialty
OncologyGI oncology
By research site
Clearview Cancer Institute· Huntsville, ALArizona Clinical Research Center· Tucson, AZUSC/Norris Comprehensive Cancer Center· Los Angeles, CALombardi Comprehensive Cancer Center, Georgetown University Hospital· Washington D.C., DCFlorida Cancer Specialists· Fort Myers, FLUniversity of Florida COllege of Medicine/Shands Cancer Center· Gainesville, FL

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