At a glance

ClinicalIndex Comparison Record

Phase 2Completed· 154 enrolled

Drug / intervention

Panitumumab +1 moredrug

Likely dose

FOLFIRI 180 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/NCT00508404

NCT00508404Phase 2Completed

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A Single Arm Multicentre Phase II Study of Panitumumab in Combination With Irinotecan/5-fluorouracil/Leucovorin in Patients With Metastatic Colorectal Cancer

Amgen·interventional·Posted Jul 30, 2007·Updated Nov 19, 2019

In Brief

A Phase 2 clinical trial evaluating Panitumumab and FOLFIRI for Metastatic Colorectal Cancer. Completed, enrolled 154 participants.

Detailed Summary

To estimate the effect of KRAS mutation status (Wild-type versus Mutant) on objective response rate and other measures of efficacy for patients treated with panitumumab in combination with a chemotherapy regimen of irinotecan, 5-fluorouracil, and leucovorin (FOLFIRI) as first-line therapy for metastatic colorectal cancer (mCRC).

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsMetastatic Colorectal Cancer

Countries--

Collaborators--

Timeline

Phase 2CompletedFinished

200720082009201020112012201320142015201620172018201920202021202220232024202520262027

Enrollment StartMay 2007

First PostedJul 2007

Primary CompletionJun 2009

Study CompletionJun 2012

TodayJul 2026

First PostedJul 30, 2007

Enrollment StartMay 9, 2007

Primary CompletionJun 1, 2009

Study CompletionJun 12, 2012

TodayJul 2, 2026

Enrollment to primary: 2.1 yearsPosted 18.9 years ago

Interventions

Panitumumabdrug

Administered by intravenous infusion

FOLFIRIdrug

FOLFIRI chemotherapy was initiated on Day 1 of each treatment cycle at the following starting doses: irinotecan 180 mg/m², leucovorin 400 mg/m², 5-fluorouracil bolus 400 mg/m², 5-fluorouracil infusion 2400 mg/m².