CI

At a glance

ClinicalIndex Comparison Record
Phase 2Withdrawn· 0 enrolled
Drug / intervention
Cetuximab +1 moredrug
Likely dose
Cetuximab 400 mg/m2from 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/NCT01960023
NCT01960023Phase 2Withdrawn
Withdrawn
CompareCT.gov

A Phase I/II Dose-Escalation Study Evaluating the Combination of Neratinib and Cetuximab in Patients With "Quadruple Wild-Type" (KRAS/NRAS/BRAF/PIK3CA Wild-Type) Metastatic Colorectal Cancer Resistant to Cetuximab

NSABP Foundation Inc·interventional·Posted Oct 10, 2013·Updated Oct 27, 2021

In Brief

A Phase 2 clinical trial evaluating Cetuximab and Neratinib for Colorectal Cancer. Withdrawn before enrollment, across 12 sites.

Signals

Trial was withdrawn before enrollment

Detailed Summary

The FC-7 study is designed as an open label, single arm, Phase I/II dose-escalation study evaluating the combination of neratinib and cetuximab in patients with metastatic colorectal cancer primary tumor that is "quadruple wild-type " (wild-type KRAS, NRAS, BRAF, PIK3CA). The primary aim in the Phase I portion of this study is to determine the safety and tolerability of the two-drug combination. The primary aim of the Phase II part is to determine the overall objective response rate (complete and partial responses) by Response Evaluation Criteria in Solid Tumors (RECIST 1.1). Patients will receive concurrent therapy with cetuximab (400 mg/m2 IV loading dose followed by 250 mg/m2 IV weekly), and neratinib.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsColorectal Cancer
CountriesUnited States
Collaborators--

Timeline

Phase 2WithdrawnFinished
2014201520162017201820192020202120222023202420252026
First PostedOct 10, 2013
Enrollment StartOct 1, 2013
Primary CompletionJul 13, 2016
TodayJul 1, 2026
Enrollment to primary: 2.8 yearsPosted 12.7 years ago

Interventions

Cetuximabdrug

400 mg/m2 IV loading dose followed by weekly cetuximab 250 mg/m2 IV until disease progression

Neratinibdrug

Phase I portion of the study: Dose level 1: 120 mg/day; Dose level 2: 160 mg/day; Dose level 3: 200 mg/day; Dose level 4: 240 mg/day Phase II portion of the study: The recommended dose determined in the Phase I portion of the study.