CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 285 enrolled
Drug / intervention
Panitumumab +2 moredrug
Likely dose
mFOLFOX6 85 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

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

Search/NCT00819780
NCT00819780Phase 2Completed
CompareCT.gov

A Randomized, Multicenter, Phase 2 Study to Compare the Efficacy of Panitumumab in Combination With mFOLFOX6 to the Efficacy of Bevacizumab in Combination With mFOLFOX6 in Patients With Previously Untreated, KRAS Wild-Type, Unresectable, Metastatic Colorectal Cancer

Amgen·interventional·Posted Jan 9, 2009·Updated Dec 6, 2022

In Brief

A Phase 2 clinical trial evaluating Panitumumab, Bevacizumab, and 1 other intervention for Colon Cancer and 3 related conditions. Completed, enrolled 285 participants across 95 sites in 6 countries.

Detailed Summary

The primary objective of this study is to estimate the treatment effect on progression-free survival (PFS) of panitumumab relative to bevacizumab in combination with mFOLFOX6 chemotherapy as first-line therapy in patients with tumors expressing wild-type KRAS, unresectable mCRC.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsColon Cancer, Colorectal Cancer, Rectal Cancer, Metastatic Colorectal Cancer
CountriesBelgium, Canada, Germany, Italy, Spain, United States
Collaborators--

Timeline

Phase 2CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedJan 9, 2009
Enrollment StartApr 24, 2009
Primary CompletionMay 30, 2012
Study CompletionJul 7, 2016
TodayJul 2, 2026
Enrollment to primary: 3.1 yearsPosted 17.5 years ago

Interventions

Panitumumabdrug

Panitumumab is a fully human immunoglobulin G (IgG)2 monoclonal antibody antagonist directed against human Epidermal Growth Factor receptor (EGFr).

Bevacizumabdrug

Bevacizumab is a humanized monoclonal IgG1 antibody that is directed against Vascular Endothelial Growth Factor (VEGF).

mFOLFOX6drug

mFOLFOX6 regimen is a combination therapy of oxaliplatin (85 mg/m\^2) administered as a 2-hour infusion on Day 1; leucovorin (400 mg/m\^2) administered as a 2-hour infusion on Day 1; followed by a loading dose of 5-fluorouracil (5-FU; 400 mg/m\^2) IV bolus administered over approximately 2 to 4 minutes on Day 1, then 5- FU (2400 mg/m\^2) via ambulatory pump administered for a period of 46 to 48 hours.