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

Stopped early · Phase 1/Phase 2

Conditions studied: Colorectal Cancer

In brief

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 facts

Study ID

NCT00838578

Run by

Kyowa Kirin Co., Ltd.

People needed

65

Starts

2009-03-01

Expected to finish

2012-10-01

Last updated by the study team

2024-04-26

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Have histologically confirmed colorectal cancer that is metastatic with measurable disease.
• 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

You may not qualify if…

• 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 (CHF).
• 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.

Where it is running

• Clearview Cancer Institute — Huntsville, Alabama, United States
• Arizona Clinical Research Center — Tucson, Arizona, United States
• USC/Norris Comprehensive Cancer Center — Los Angeles, California, United States
• Lombardi Comprehensive Cancer Center, Georgetown University Hospital — Washington D.C., District of Columbia, United States
• Florida Cancer Specialists — Fort Myers, Florida, United States
• University of Florida COllege of Medicine/Shands Cancer Center — Gainesville, Florida, United States
• University of Miami - Sylvester Comprehensive Cancer Center — Miami, Florida, United States
• Emory University - Winship Cancer Institute — Atlanta, Georgia, United States
• Greater Baltimore Medical Center — Baltimore, Maryland, United States
• NYU Clinical Trials Office, New York University Cancer Institute — New York, New York, United States
• Sarah Cannon Research Institute — Nashville, Tennessee, United States
• Vanderbilt University Medical Center — Nashville, Tennessee, United States

Full record on ClinicalTrials.gov

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