At a glance

ClinicalIndex Comparison Record

Phase 2Completed· 116 enrolled

Drug / intervention

Panitumumab +1 morebiological

Likely dose

Not stated in 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/NCT00411450

NCT00411450Phase 2Completed

Compare CT.gov

Multi Center, Open Label, Single Arm Trial Evaluating Panitumumab in Combination With FOLFIRI Therapy Following First Line FOLFOX and Bevacizumab Treatment of Metastatic Colorectal Cancer

Amgen·interventional·Posted Dec 14, 2006·Updated Feb 15, 2016

In Brief

A Phase 2 clinical trial evaluating Panitumumab and FOLFIRI for Colon Cancer and 6 related conditions. Completed, enrolled 116 participants.

Detailed Summary

The primary objective is to estimate the effect of the human homolog of the Kirsten rat sarcoma-2 virus oncogene (KRAS) mutation status (wild type versus mutant) from tumor tissue on efficacy endpoints in patients with metastatic colorectal cancer (mCRC) receiving second-line chemotherapy with panitumumab after failing first-line treatment.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsColon Cancer, Colorectal Cancer, Rectal Cancer, Cancer, Metastatic Cancer, Metastatic Colorectal Cancer, Oncology

Countries--

Collaborators--

Timeline

Phase 2CompletedFinished

200720082009201020112012201320142015201620172018201920202021202220232024202520262027

Enrollment StartNov 2006

First PostedDec 2006

Primary CompletionJan 2009

Study CompletionOct 2010

TodayJul 2026

First PostedDec 14, 2006

Enrollment StartNov 1, 2006

Primary CompletionJan 1, 2009

Study CompletionOct 1, 2010

TodayJul 2, 2026

Enrollment to primary: 2.2 yearsPosted 19.6 years ago

Interventions

Panitumumabbiological

Administered by intravenous infusion

FOLFIRIdrug

Chemotherapy consisting of irinotecan with infusional 5-fluorouracil and leucovorin. Recommended dosage regimen and administration of FOLFIRI was based on local standard of care, the package insert for each product, and institutional guidelines.