NCT00838578

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

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

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 65 (actual)
• Sponsor: Kyowa Kirin Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Colorectal Cancer

Interventions

Type	Name	Description
BIOLOGICAL	KRN330	KRN330 will be dosed at 0.5 mg/kg weekly until disease progression.
DRUG	Irinotecan	Irinotecan will be dosed at 180 mg/m2 biweekly until disease progression.

Timeline

• Start date: 2009-03-01
• Primary completion: 2012-07-01
• Completion: 2012-10-01
• First posted: 2009-02-06
• Last updated: 2024-04-26
• Results posted: 2015-03-23

Locations

12 sites across 1 country: United States