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A Study of Tucatinib (ONT-380) Combined With Capecitabine and/or Trastuzumab in Patients With HER2+ Metastatic Breast Cancer

NCT02025192 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2020-06-04

No results posted yet for this study

Summary

The purpose of this study is to determine the maximal tolerated dose (MTD) or recommended phase 2 dose (RP2D) of tucatinib (ONT-380) and to assess the safety and tolerability of tucatinib (ONT-380) combined with capecitabine alone, trastuzumab alone and with both capecitabine and trastuzumab in patients with HER2+ metastatic breast cancer.

Conditions

  • HER2 Positive Metastatic Breast Cancers

Interventions

DRUG

Tucatinib

Administered twice per day, orally.

DRUG

Capecitabine

1000mg/m\^2 administered twice per day, orally in Days 1-14 of each 21-day cycle.

DRUG

Trastuzumab

Administered at a loading dose of 8 mg/kg IV followed by 6 mg/kg 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
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-12-31
Primary Completion
2017-10-03
Completion
2020-03-16

Countries

  • United States

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 NCT02025192 on ClinicalTrials.gov