NCT01801904

A Phase 2 Study of Panitumumab in Patients With Cetuximab-refractory Metastatic Colorectal Cancer

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 52 (actual)
• Sponsor: National Cancer Institute, Naples · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to assess if panitumumab is active enough to warrant comparative studies in patients with metastatic colorectal cancer that has progressed after treatment with cetuximab.

Detailed description

The study was amended with modification of inclusion criteria (from wild-type tumor KRAS gene to wild-type RAS gene, including KRAS and NRAS exons 2, 3 and 4) RAS mutational status of tumors of patients enrolled before amendment 1 approval will be centrally revised. Patients whose tumors will result RAS mutated at the biomarkers central revision, will be replaced. Therefore, the overall sample size at both the stages may be higher than the one initially planned.

Conditions

• Metastatic Colorectal Cancer

Interventions

Type	Name	Description
DRUG	Panitumumab	6mg/kg IV given every 2 weeks until disease progression or unacceptable toxicity

Timeline

• Start date: 2012-12-01
• Primary completion: 2024-12-01
• Completion: 2024-12-01
• First posted: 2013-03-01
• Last updated: 2023-03-24

Locations

5 sites across 1 country: Italy