NCT03043313

Tucatinib Plus Trastuzumab in Patients With HER2+ Colorectal Cancer

MOUNTAINEER: A Phase II, Open Label Study of Tucatinib Combined With Trastuzumab in Patients With HER2+ Metastatic Colorectal Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 117 (actual)
• Sponsor: Seagen Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This trial studies how well the drug tucatinib works when given with trastuzumab and when given by itself. The participants in this trial have HER2-positive (HER2+) metastatic colorectal cancer (mCRC). 'Metastatic' means that the cancer has spread to other parts of the body. In the first part of this study, participants enrolled into Cohort A and received both tucatinib and trastuzumab. In the second part of this study, participants are randomly assigned to either Cohort B or Cohort C. Participants in Cohort B will receive tucatinib and trastuzumab. Participants in Cohort C will receive tucatinib. Participants in Cohort C who do not respond to therapy may have an option to receive tucatinib plus trastuzumab.

Conditions

• Metastatic Colorectal Adenocarcinoma

Interventions

Type	Name	Description
DRUG	Trastuzumab	Given intravenously (into the vein; IV)
DRUG	Tucatinib	Given orally

Timeline

• Start date: 2017-06-23
• Primary completion: 2022-03-28
• Completion: 2023-11-02
• First posted: 2017-02-06
• Last updated: 2024-11-26
• Results posted: 2023-04-18

Locations

56 sites across 5 countries: United States, Belgium, France, Italy, Spain

Regulatory

• FDA-regulated drug study