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Tucatinib Plus Trastuzumab in Patients With HER2+ Colorectal Cancer

NCT03043313 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 117

Last updated 2024-11-26

Study results available
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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

DRUG

Trastuzumab

Given intravenously (into the vein; IV)

DRUG

Tucatinib

Given orally

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Academic and Community Cancer Research United

    collaborator OTHER

  • Seagen Inc.

    lead INDUSTRY

Principal Investigators

  • John H Strickler · Academic and Community Cancer Research United

  • Jorge Ramos, DO · Seagen Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-06-23
Primary Completion
2022-03-28
Completion
2023-11-02
FDA Drug
Yes

Countries

  • United States
  • Belgium
  • France
  • Italy
  • Spain

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03043313 on ClinicalTrials.gov