CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 254 enrolled
Drug / intervention
Sym004 (12 mg/kg) +4 moredrug
Likely dose
Sym004 (12 mg/kg)from 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/NCT02083653
NCT02083653Phase 2Completed
CompareCT.gov

Open-label, Randomized, Controlled, Multicenter Phase II Trial Investigating 2 Sym004 Doses Versus Investigator's Choice (Best Supportive Care, Capecitabine, 5-FU) in Subjects With Metastatic Colorectal Cancer and Acquired Resistance to Anti-EGFR Monoclonal Antibodies

Symphogen A/S·interventional·Posted Mar 11, 2014·Updated Apr 16, 2019

In Brief

A Phase 2 clinical trial evaluating Sym004 (12 mg/kg), Sym004 (9/6 mg/kg), and 3 other interventions for Metastatic Colorectal Cancer. Completed, enrolled 254 participants across 54 sites in 10 countries.

Detailed Summary

This is a Phase 2, open-label, randomized, 3-arm trial investigating the efficacy of two Sym004 doses (Arm A and Arm B) compared with a control group (Arm C) in subjects with metastatic colorectal cancer (mCRC) and acquired resistance to anti-epidermal growth factor receptor (EGFR) monoclonal antibodies (mAbs).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMetastatic Colorectal Cancer
CountriesAustria, Belgium, France, Germany, Hungary, Italy, Poland, Russia, Spain, United States
Collaborators--

Timeline

Phase 2CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedMar 11, 2014
Enrollment StartMar 6, 2014
Primary CompletionOct 24, 2016
Study CompletionApr 26, 2017
TodayJul 2, 2026
Enrollment to primary: 2.6 yearsPosted 12.3 years ago

Interventions

Sym004 (12 mg/kg)drug

Sym004 is a 1:1 mixture of two mAbs (futuximab and modotuximab) which bind to two non-overlapping epitopes of the EGFR.

Sym004 (9/6 mg/kg)drug

Sym004 is a 1:1 mixture of two mAbs (futuximab and modotuximab) which bind to two non-overlapping epitopes of the EGFR.

Best Supportive Care (BSC)other

BSC is the best palliative care as per Investigator's discretion, excluding antineoplastic agents. BSC may include, but is not limited to, antibiotics, analgesics, antiemetics, blood transfusions, and nutritional support.

Fluorouracil (5-FU)drug

5-FU will be administered at doses and schedules as per Investigator's discretion and in line with the local package insert.

Capecitabinedrug

Capecitabine will be administered at doses and schedules as per Investigator's discretion and in line with the local package insert.