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Phase I/II Study of KRN330 Plus Irinotecan After First-Line or Adjuvant FOLFOX/CapOx Failure in Patients With Metastatic Colorectal Cancer

Phase 1/Phase 2
18 Years
Not Enrolling
Colorectal Cancer

Thank you

Trial Information

Phase I/II Study of KRN330 Plus Irinotecan After First-Line or Adjuvant FOLFOX/CapOx Failure in Patients With Metastatic Colorectal Cancer

Phase II portion is an open-label, single arm study. Based on the results of the Phase I
portion, weekly KRN330 (0.5 mg/kg) and biweekly irinotecan (180 mg/m2) will be used in the
Phase II portion. To be eligible for the Phase II portion, a patient will have recurred or
progressed within 6 months of the last cycle of FOLFOX/CapOx +/- bevacizumab (first-line or
adjuvant regimen for metastatic colorectal cancer). Patients will continue the treatment
until disease progression.

Per protocol, the decision was made to terminate the study based on interim analysis
results. The Response Rate in Phase II did not meet the protocol-specified RR of 15% when
0.5 mg/kg KRN330 was administered weekly in combination with irinotecan(180 mg/m2)biweekly.
The efficacy analysis,based on the intent-to-treat population (44 subjects) was shown to be

Inclusion Criteria:

- Have histologically confirmed colorectal cancer that is metastatic with measurable

- For the Phase II portion: Have recurred or progressed within 6 months of the last
cycle of FOLFOX +/- bevacizumab first-line or adjuvant regimen for metastatic
colorectal cancer. Note: Those who had initiated FOLFOX/CapOx but stopped oxaliplatin
because of intolerable toxicity are also eligible.

- At least 4 weeks have elapsed since the last chemotherapy, radiotherapy,
immunotherapy, or biologic therapy prior to enrollment (except at least 6 weeks in
the case of nitrosourea and mitomycin).

- Have not received any other investigational agents within 4 weeks of study entry and
have fully recovered from any adverse event due to prior therapy.

- At least 4 weeks have elapsed since any major surgery.

- Have ECOG performance status of 0, 1, or 2.

- Have adequate bone marrow and organ function

Exclusion Criteria:

- Have an active, uncontrolled infection.

- Have known HIV positive status.

- Have known or suspected cerebral metastasis.

- Have had a myocardial infarction (MI) or cerebrovascular accident (CVA) within the
last 6 months; or meet the criteria for AHA class III or IV congestive heart failure

- Have a medical condition requiring chronic use of high-dose corticosteroids or other
chronic immunosuppressive therapy (e.g. methotrexate, azathioprine).

- Have a history of greater than or equal to Grade 2 allergic reaction or
hypersensitivity following exposure to humanized or human monoclonal antibodies (but
not chimeric antibodies).

- Pregnant or breastfeeding women and male or female patients who do not agree to use
effective contraceptive method(s) during the study.

Type of Study:


Study Design:

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

Outcome Measure:

Response rate and progression-free survival

Outcome Time Frame:

Until disease progression post initial KRN330 treatment

Safety Issue:


Principal Investigator

Michael Kurman, MD

Investigator Role:

Study Director

Investigator Affiliation:

Kyowa Hakko Kirin Pharma, Inc.


United States: Food and Drug Administration

Study ID:




Start Date:

March 2009

Completion Date:

October 2012

Related Keywords:

  • Colorectal Cancer
  • KRN330
  • Colorectal Cancer
  • Antimetabolites
  • Antimetabolites, Antineoplastic
  • Digestive System Neoplasms
  • Immunologic Factors
  • Molecular Mechanisms of Pharmacological Action
  • Antineoplastic Agents
  • Gastrointestinal Diseases
  • Physiological Effects of Drugs
  • Colonic Diseases
  • Irinotecan
  • Enzyme Inhibitors
  • Intestinal Diseases
  • Immunosuppressive Agents
  • Rectal Diseases
  • Pharmacologic Actions
  • Intestinal Neoplasms
  • Neoplasms
  • Neoplasms by Site
  • Digestive System Diseases
  • Therapeutic Uses
  • Fluorouracil
  • Gastrointestinal Neoplasms
  • Antineoplastic Agents, Phytogenic
  • Colorectal Neoplasms
  • Colorectal Neoplasms



USC/Norris Comprehensive Cancer Center Los Angeles, California  90033-0800
Florida Cancer Specialists Fort Myers, Florida  33901
Vanderbilt University Medical Center Nashville, Tennessee  37232-2516
Greater Baltimore Medical Center Baltimore, Maryland  21204
Arizona Clinical Research Center Tucson, Arizona  85712
Clearview Cancer Institute Huntsville, Alabama  35805
Emory University - Winship Cancer Institute Atlanta, Georgia  30322-1013
Sarah Cannon Research Institute Nashville, Tennessee  37203
University of Miami - Sylvester Comprehensive Cancer Center Miami, Florida  33136
Lombardi Comprehensive Cancer Center, Georgetown University Hospital Washington, District of Columbia  20007-2113
University of Florida COllege of Medicine/Shands Cancer Center Gainesville, Florida  32610
NYU Clinical Trials Office, New York University Cancer Institute New York, New York  10016