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A Study of Tucatinib (ONT-380) Combined With Ado-trastuzumab Emtansine (T-DM1) in Patients With HER2+ Breast Cancer

NCT01983501 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 57

Last updated 2020-09-21

No results posted yet for this study

Summary

The purpose of this study is to determine the maximal tolerated dose (MTD) or recommended dose (RD) and to assess the safety and tolerability of tucatinib (ONT-380) combined with ado-trastuzumab emtansine (T-DM1) in patients with HER2+ breast cancer.

Conditions

  • HER2 Positive Breast Cancers

Interventions

DRUG

Tucatinib (ONT-380)

Given twice per day, orally

DRUG

T-DM1

Given intravenously once every 21 days

Sponsors & Collaborators

  • Seagen Inc.

    lead INDUSTRY

Principal Investigators

  • JoAl Mayor, PharmD, BCOP · Seagen Inc.

  • Corinna Palanca-Wessels, MD, PhD · Seagen Inc.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-02-28
Primary Completion
2017-10-10
Completion
2020-09-03

Countries

  • United States
  • Canada

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 NCT01983501 on ClinicalTrials.gov