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

• Status: Terminated
• Trial end date: 2012-10-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Kyowa Hakko Kirin Pharma, Inc.
• Treatments: Antibodies, Monoclonal; Antimetabolites; Antimetabolites, Antineoplastic; Antineoplastic Agents; Antineoplastic Agents, Phytogenic; Camptothecin; Irinotecan; Molecular Mechanisms of Pharmacological Action

Criteria

Inclusion Criteria:

• 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

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 (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.