Tucatinib, trastuzumab, ramucirumab, and paclitaxel in HER2+ gastroesophageal cancer - Clinical Trial

What is the Purpose of this Study?

We are doing this study to see if the study drug, tucatinib, is safe and effective to use with trastuzumab, ramucirumab, and paclitaxel. We also want to find the best dose of paclitaxel to use when combined with the 3 other drugs.

What is the Condition Being Studied?

HER2+ Gastroesophageal Cancer

Who Can Participate in the Study?

Adults with HER2+ cancer and one of the following tumor types:
-Gastric adenocarcinoma (a type of stomach cancer)
-Gastroesophageal junction adenocarcinoma (a type of cancer that occurs where the esophagus meets the stomach)

Age Group
Adults

What is Involved?

If you choose to join this study, you will:
-Take the study drug, tucatinib, by mouth twice a day
-Get trastuzumab, ramucirumab, and paclitaxel through an I.V. once every 1 to 2 weeks
-Give blood and urine samples
-Have regular CT or MRI scans

Study Details

Full Title
[SGNTUC-022] MOUNTAINEER-02: A randomized, double-blind, placebo-controlled, active comparator Phase 2/3 study of tucatinib in combination with trastuzumab, ramucirumab, and paclitaxel in subjects with previously treated, locally-advanced unresectable or metastatic HER2+ gastric or gastroesophageal junction adenocarcinoma (GEC)
Principal Investigator
Medical Oncologist
Protocol Number
IRB: PRO00106250
NCT: NCT04499924
Phase
Phase II
ClinicalTrials.gov
Enrollment Status
Open for Enrollment
Participate
Contact the Duke Recruitment Innovation Center
MyResearchPartners@duke.edu
or
919-681-5698