Conditions: Colorectal Cancer
Keywords: 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 by Site Digestive System Diseases Therapeutic Uses Fluorouracil Neoplasms Gastrointestinal Neoplasms Antineoplastic Agents, Phytogenic Colorectal Neoplasms
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 65
Healthy volunteers: no

Brief 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.

Detailed description:
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.

Arms:
arm 1: open label, single arm

Interventions: intervention 1: KRN330 intervention 2: Irinotecan
Intervention descriptions: intervention 1: KRN330 will be dosed at 0.5 mg/kg weekly until disease progression. intervention 2: Irinotecan will be dosed at 180 mg/m2 biweekly until disease progression.

Protocol document: