CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 18 enrolled
Drug / intervention
Oxaliplatin +4 moredrug
Likely dose
Oxaliplatin 85 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/NCT03783936
NCT03783936Phase 2Completed
CompareCT.gov

A Single Arm, Multi-center Phase 2 Trial of mFOLFOX6 + Trastuzumab + Avelumab in First-line, Metastatic, HER2-amplified Gastric and Esophageal Adenocarcinomas

Ashwin Somasundaram·interventional·Posted Dec 21, 2018·Updated Dec 19, 2023

In Brief

A Phase 2 clinical trial evaluating Oxaliplatin, Leucovorin, and 3 other interventions for Gastric Adenocarcinoma and 3 related conditions. Completed, enrolled 18 participants across 7 sites.

Detailed Summary

The initial intent of the study was to be a multi-center single-arm open-label Simon's two-stage Phase II clinical trial of first-line mFOLFOX6 + trastuzumab + avelumab in metastatic HER2-amplified gastric and esophageal adenocarcinomas. Accrual will halt after completion of Stage I (enrollment of 18 patients). This decision is not due to safety issues. Subjects currently on treatment will continue until criteria as defined in the protocol is met.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsGastric Adenocarcinoma, Esophageal Adenocarcinoma, Metastasis, HER-2 Gene Amplification
CountriesUnited States
CollaboratorsEMD Serono, University of North Carolina, Chapel Hill

Timeline

Phase 2CompletedFinished
20192020202120222023202420252026
First PostedDec 21, 2018
Enrollment StartJan 24, 2019
Primary CompletionSep 11, 2020
Study CompletionAug 30, 2022
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 7.5 years ago

Interventions

Oxaliplatindrug

Oxaliplatin 85 mg/m2

Leucovorindrug

Leucovorin 400 mg/m2

5 fluorouracildrug

5 fluorouracil 400 mg/m2 bolus and 2400 mg/m2 continuous infusion

Trastuzumabdrug

Trastuzumab 6 mg/kg loading dose C1D1 then 4 mg/kg Day 1

Avelumabdrug

Avelumab 800 mg