CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 164 enrolled
Drug / intervention
oxaliplatin (OXA), levofolinate calcium (l-LV), 5-FU, panitumumab +1 moredrug
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/NCT02337946
NCT02337946Phase 2Completed

A Phase 2 Randomized Study Comparing the Efficacy and Safety of mFOLFOX6+Panitumumab Combination Therapy and 5-FU/LV+Panitumumab Combination Therapy in the Patients With Chemotherapy-Naive Unresectable Advanced Recurrent Colorectal Carcinoma of KRAS Wild-Type After 6 Cycles of Combination Therapy With mFOLFOX6+Panitumumab

Takeda·interventional·Posted Jan 14, 2015·Updated Sep 10, 2019

In Brief

A Phase 2 clinical trial evaluating oxaliplatin (OXA), levofolinate calcium (l-LV), 5-FU, panitumumab for Colorectal Carcinoma. Completed, enrolled 164 participants across 49 sites.

Detailed Summary

The purpose of this study is to exploratorily examine efficacy and safety in the participants with chemotherapy-naïve unresectable, advanced/recurrent colorectal carcinoma of Kirsten rat sarcoma-2 virus (KRAS) wild-type who have been treated with 6 cycles (2 weeks/cycle) of first-line mFOLFOX6 + panitumumab combination therapy and then assigned to two groups i.e., a group receiving 5-FU/LV + panitumumab combination therapy and a group receiving mFOLFOX6 + panitumumab combination therapy.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesJapan
Collaborators--

Timeline

Phase 2CompletedFinished
201520162017201820192020202120222023202420252026
First PostedJan 14, 2015
Enrollment StartOct 16, 2014
Primary CompletionMar 31, 2017
Study CompletionAug 31, 2017
TodayJul 2, 2026
Enrollment to primary: 2.5 yearsPosted 11.5 years ago

Interventions

oxaliplatin (OXA), levofolinate calcium (l-LV), 5-FU, panitumumabdrug

oxaliplatin (OXA), levofolinate calcium (l-LV), panitumumab: intra-venous infusion 5-FU: bolus and continuous intra-venous infusion

oxaliplatin (OXA), levofolinate calcium (l-LV), 5-FU, panitumumabdrug