CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 42 enrolled
Drug / intervention
Afatinib and Paclitaxeldrug
Likely dose
Afatinib and Paclitaxel 40 mgfrom 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/NCT01522768
NCT01522768Phase 2Completed

A Phase II Study of Afatinib and Paclitaxel in Patients With Advanced HER2-Positive Trastuzumab Refractory Advanced Esophagogastric Cancer

Memorial Sloan Kettering Cancer Center·interventional·Posted Feb 1, 2012·Updated Nov 1, 2023

In Brief

A Phase 2 clinical trial evaluating Afatinib and Paclitaxel for Esophageal Cancer and Gastric Cancer. Completed, enrolled 42 participants across 9 sites.

Detailed Summary

The purpose of this study is to find out what effects, good or bad, the combination of standard chemotherapy agent paclitaxel with the investigational (experimental) drug afatinib that targets HER2, has on HER2-positive esophagogastric cancer that started to get bigger despite previous treatment with trastuzumab. The doctors will also study the tumor to understand why it grew while on trastuzumab treatment and to see the effects afatinib and paclitaxel has on the tumor.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 2CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedFeb 1, 2012
Enrollment StartMar 1, 2012
Primary CompletionFeb 20, 2023
TodayJul 2, 2026
Enrollment to primary: 11.0 yearsPosted 14.4 years ago

Interventions

Afatinib and Paclitaxeldrug

All patients receiving therapy on trial with afatinib and trastuzumab will continue on afatinib and trastuzumab until disease progression or intolerable toxicity. All additional patients will be enrolled on afatinib and paclitaxel. Patients will be treated with afatinib and paclitaxel combination. Patients will receive oral afatinib 40 mg daily plus paclitaxel 80 mg/m\^2 intravenously on day 1, 8, and 15 of a 28-day cycle.