Phase
Condition
Rectal Cancer
Colon Cancer
Rectal Disorders
Treatment
N/AClinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Disease progression on an irinotecan-based first-line chemotherapy regimen (ie FOLFIRIor CAPIRI [capecitabine + irinotecan], with or without bevacizumab)
Age ≥ 18 years
Life expectancy of ≥ 6 months
Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0-1 at study entry
Agrees to adequate contraception during the study period and for 12 weeks after thelast dose of study medication
Provided signed informed consent
Exclusion
Exclusion Criteria:
Has received prior oxaliplatin-based chemotherapy for locally advanced unresectable ormetastatic Colorectal Cancer (CRC) (Prior oxaliplatin-based adjuvant chemotherapy isallowed if the last dose of oxaliplatin was administered > 12 months prior torandomization)
Has documented and/or symptomatic brain or leptomeningeal metastases
Has an ongoing or active infection, symptomatic or poorly controlled cardiacarrhythmia, psychiatric illness/social situations, or any other serious uncontrolledmedical disorders
On chronic non-topical corticosteroid treatment. A participant discontinuing suchtreatment > 3 months prior to randomization is eligible
Has uncontrolled or poorly controlled hypertension on a standard regimen ofantihypertensive therapy
Has a concurrent active malignancy. A participant with previous history of malignancyis eligible, provided that he/she has been disease free for > 3 years
If female, is pregnant (confirmed by serum beta human chorionic gonadotropin [βHCG]test) or lactating
Has received a prior autologous or allogeneic organ or tissue transplantation
Has undergone major surgery within 28 days prior to randomization
Has had a serious nonhealing wound, ulcer, or bone fracture within 28 days prior torandomization
Has an elective or planned major surgery to be performed during the course of thetrial
Has a history of inflammatory bowel disease requiring pharmacological and/or surgicalintervention in the 12 months prior to randomization
Study Design
Study Description
Connect with a study center
ImClone Investigational Site
Calgary, Alberta T2N 4N2
CanadaSite Not Available
ImClone Investigational Site
Edmonton, Alberta T6G 1Z2
CanadaSite Not Available
ImClone Investigational Site
Kelowna, British Columbia V1Y 5L3
CanadaSite Not Available
ImClone Investigational Site
Surrey, British Columbia V3V 1Z2
CanadaSite Not Available
ImClone Investigational Site
Vancouver, British Columbia V5Z 4E6
CanadaSite Not Available
ImClone Investigational Site
Halifax, Nova Scotia B3H 1V7
CanadaSite Not Available
ImClone Investigational Site
Hamilton, Ontario L8V 5C2
CanadaSite Not Available
ImClone Investigational Site
London, Ontario N6A 4L6
CanadaSite Not Available
ImClone Investigational Site
Mississauga, Ontario L5M 2N1
CanadaSite Not Available
ImClone Investigational Site
Oshawa, Ontario L1G 2B9
CanadaSite Not Available
ImClone Investigational Site
Ottawa, Ontario K1H 8L6
CanadaSite Not Available
ImClone Investigational Site
Toronto, Ontario M5G 2M9
CanadaSite Not Available
ImClone Investigational Site
Windsor, Ontario N8W 2X3
CanadaSite Not Available
ImClone Investigational Site
Montreal, Quebec H2W 156
CanadaSite Not Available
ImClone Investigational Site
Montréal, Quebec H3G 1A1
CanadaSite Not Available
ImClone Investigational Site
Montréal, Quebec H3T 1E2
CanadaSite Not Available
ImClone Investigational Site
Hudson, Florida 34667
United StatesSite Not Available
ImClone Investigational Site
New Port Richey, Florida 34655
United StatesSite Not Available
ImClone Investigational Site
Crestview Hills, Kentucky 41017
United StatesSite Not Available
ImClone Investigational Site
Cincinnati, Ohio 45242
United StatesSite Not Available
ImClone Investigational Site
Fairfield, Ohio 45014
United StatesSite Not Available
ImClone Investigational Site
Columbia, South Carolina 29210
United StatesSite Not Available
ImClone Investigational Site
Franklin, Tennessee 37067
United StatesSite Not Available
ImClone Investigational Site
Gallatin, Tennessee 37066
United StatesSite Not Available
ImClone Investigational Site
Hermitage, Tennessee 37076
United StatesSite Not Available
ImClone Investigational Site
Jackson, Tennessee 38301
United StatesSite Not Available
ImClone Investigational Site
Lebanon, Tennessee 37087
United StatesSite Not Available
ImClone Investigational Site
Murfreesboro, Tennessee 37130
United StatesSite Not Available
ImClone Investigational Site
Nashville, Tennessee 37232
United StatesSite Not Available
ImClone Investigational Site
Smyrna, Tennessee 37167
United StatesSite Not Available
ImClone Investigational Site
Tyler, Texas 75701
United StatesSite Not Available

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