NCT01139138

Safety Study of the Combination of Panitumumab, Irinotecan and Everolimus in the Treatment of Advanced Colorectal Cancer

A Phase IB/II Study of Second Line Therapy With Panitumumab, Irinotecan and Everolimus (PIE) in Metastatic Colorectal Cancer With KRAS WT

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 49 (actual)
• Sponsor: The Queen Elizabeth Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study will assess the safety of panitumumab, irinotecan and everolimus when given in combination to treat advanced colorectal cancer

Detailed description

This is an open label uncontrolled phase IB/II study to determine the maximum tolerated dose (MTD) and assess the efficacy of everolimus, irinotecan and panitumumab when given in combination for patients with metastatic colorectal cancer and KRAS wild-type (WT). Patients with metastatic colorectal cancer (mCRC) that have failed fluorouracil based first line therapy will be included. It is anticipated that approximately 50 patients will be enrolled over a period of 24 months

Conditions

• Colorectal Cancer
• Colorectal Carcinoma
• Colorectal Tumors
• Neoplasms, Colorectal

Interventions

Type	Name	Description
DRUG	Panitumumab	Panitumumab 6mg/kg IV every 14 days
DRUG	Irinotecan	Irinotecan 200mg/m2 IV every 14 days
DRUG	Everolimus	Everolimus daily po (dosage varies with cohort)

Timeline

• Start date: 2010-06-01
• Primary completion: 2015-08-01
• Completion: 2017-06-01
• First posted: 2010-06-08
• Last updated: 2017-11-06

Locations

1 site across 1 country: Australia