Tucatinib, trastuzumab, ramucirumab, and paclitaxel in HER2+ gastroesophageal cancer

What is the Purpose of this Study?

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
What is the Condition Being Studied?
HER2+ Gastroesophageal Cancer

Who Can Participate in this 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
Participating Institutions

What is Involved?

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.

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

Contacts
Protocol Number
IRB:
PRO00106250

NCT:
NCT04499924
ClinicalTrials.gov
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