NCT00891930

Study to Evaluate Mechanisms of Acquired Resistance to Panitumumab

Phase 2 Study of Panitumumab Plus Irinotecan Followed by Panitumumab Plus AMG 479 in Subjects With Metastatic Colorectal Carcinoma Expressing Wild Type KRAS and Refractory to Oxaliplatin-or Irinotecan- and Oxaliplatin-containing Regimens to Evaluate Mechanisms of Acquired Resistance to Panitumumab

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 74 (actual)
• Sponsor: NantBioScience, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is designed to evaluate the mechanism(s) of resistance to the anti-epidermal growth factor receptor (EGFR) antibody panitumumab given in combination with irinotecan in metastatic colorectal carcinoma (mCRC) patients with wild-type Kirsten rat sarcoma-2 virus oncogene (KRAS) tumor status at the time of initial diagnosis.

Detailed description

In Part 1, all participants will undergo a baseline tumor biopsy and will receive panitumumab with irinotecan. Participants who respond or have stable disease will continue to receive treatment until radiographically-confirmed disease progression. These participants will then undergo a second tumor biopsy and blood sampling and then proceed to Part 2 of the study. Participants with radiographically confirmed disease progression at the time of the first tumor measurement will undergo blood sampling and proceed directly to Part 2. In Part 2, participants will receive panitumumab with ganitumab. In both parts of the study, panitumumab and irinotecan (Part 1) and panitumumab and ganitumab (Part 2) will be administered every 2 weeks until disease progression, intolerability, withdrawal of consent, death, or unless otherwise indicated by the study team.

Conditions

• Metastatic Colorectal Cancer

Interventions

Type	Name	Description
BIOLOGICAL	Panitumumab	Panitumumab 6 mg/kg administered via IV infusion over 60 minutes
BIOLOGICAL	Ganitumab	AMG 479 12 mg/kg adminstered by IV infusion over 60 minutes
DRUG	Irinotecan	Irinotecan starting dose of 180 mg/m² adminstered via IV infusion

Timeline

• Start date: 2009-05-05
• Primary completion: 2013-07-22
• Completion: 2013-07-22
• First posted: 2009-05-01
• Last updated: 2024-07-17
• Results posted: 2016-02-08