CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 203 enrolled
Drug / intervention
Panitumumabdrug
Likely dose
Panitumumab administered by intravenous infusion (specific dose not stated in eligibility/intervention information)AI-extracted
Key inclusion· 8
  • ✓Pathologically confirmed metastatic colorectal adenocarcinoma
  • ✓Evidence of disease progression during or after fluoropyrimidine, irinotecan, and oxaliplatin chemotherapy
  • ✓Radiographic documentation of disease progression during or within 6 months of most recent chemotherapy
  • ✓Bidimensionally measurable disease
Key exclusion· 5
  • ✕Symptomatic brain metastases requiring treatment
  • ✕History of or current evidence of interstitial pneumonitis or pulmonary fibrosis
  • ✕Prior anti-EGFR antibody therapy (small molecule EGFR tyrosine kinase inhibitors are permitted)
  • ✕Systemic chemotherapy or radiotherapy within 30 days of enrollment

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00089635
NCT00089635Phase 2Completed
CompareCT.gov

A Phase 2 Multicenter Single Arm Clinical Trial of ABX-EGF Monotherapy in Subjects With Metastatic Colorectal Cancer Whose Tumors Express Low or Negative EGFr Levels of Immunohistochemistry Following Treatment With Fluoropyrimidine, Irinotecan, and Oxaliplatin Chemotherapy

Amgen·interventional·Posted Aug 11, 2004·Updated Nov 7, 2022

In Brief

A Phase 2 clinical trial evaluating Panitumumab for Colorectal Cancer and Metastases. Completed, enrolled 203 participants.

Detailed Summary

The purpose of this study is to determine that panitumumab will have clinically meaningful anti-tumor activity in patients with metastatic colorectal cancer who have developed progressive disease or relapsed while on or after prior fluoropyrimidine, irinotecan and oxaliplatin chemotherapy.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsColorectal Cancer, Metastases
Countries--
Collaborators--

Timeline

Phase 2CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedAug 11, 2004
Enrollment StartAug 1, 2004
Primary CompletionJan 1, 2007
Study CompletionAug 1, 2008
TodayJul 2, 2026
Enrollment to primary: 2.4 yearsPosted 21.9 years ago

Interventions

Panitumumabdrug

Administered by intravenous infusion