Trials Sponsors Conditions Drugs Pricing

Conditions

HER2 Positive Breast Cancers

Keywords

ONT-380T-DM1KadcylaBreast cancerARRY-380Tucatinib

Outcome Measures

Primary Outcomes (1)

Incidence of adverse events
12 months

Secondary Outcomes (8)

Incidence of clinical lab abnormalities
12 months
Frequency of dose reductions in tucatinib
12 months
Frequency of dose reductions in T-DM1
12 months
Objective response rate (ORR)
12 months
Duration of response
12 months
+3 more secondary outcomes

Study Arms (1)

Tucatinib (ONT-380) in combination with T-DM1

EXPERIMENTAL

Drug: Tucatinib (ONT-380)Drug: T-DM1

Interventions

Tucatinib (ONT-380)Drug

Given twice per day, orally

Tucatinib (ONT-380) in combination with T-DM1

T-DM1Drug

Given intravenously once every 21 days

Also known as: Kadcyla

Tucatinib (ONT-380) in combination with T-DM1

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

HER2+ metastatic breast cancer, documented as HER2+ by FISH and/or 3+ staining by immunohistochemistry.
History of prior therapy with trastuzumab and a taxane, separately or in combination. For patients in dose escalation and MTD expansion cohorts, prior therapy with trastuzumab and a taxane must have been for metastatic disease. For patients in CNS disease expansion cohorts, trastuzumab and taxane (together or separately) may have been given at any time prior to study enrollment as part of neoadjuvant therapy, adjuvant therapy, or therapy for metastatic disease.

Sponsors & Collaborators

Seagen Inc.
Industrylead

Study Sites (11)

University of Alabama

Birmingham, Alabama, 35294, United States

University of Colorado Cancer Center

Aurora, Colorado, 80045, United States

University of Kansas

Kansas City, Kansas, 66160, United States

Dana Farber Cancer Institute

Boston, Massachusetts, 02215, United States

Providence Cancer Center

Portland, Oregon, 97213, United States

Sarah Cannon Research Institute

Nashville, Tennessee, 37203, United States

Northwest Medical Specialties

Tacoma, Washington, 98045, United States

Related Publications (2)

Zhang D, Taylor A, Zhao JJ, Endres CJ, Topletz-Erickson A. Population Pharmacokinetic Analysis of Tucatinib in Healthy Participants and Patients with Breast Cancer or Colorectal Cancer. Clin Pharmacokinet. 2024 Oct;63(10):1477-1487. doi: 10.1007/s40262-024-01412-0. Epub 2024 Oct 5.
PMID: 39368039DERIVED
Borges VF, Ferrario C, Aucoin N, Falkson C, Khan Q, Krop I, Welch S, Conlin A, Chaves J, Bedard PL, Chamberlain M, Gray T, Vo A, Hamilton E. Tucatinib Combined With Ado-Trastuzumab Emtansine in Advanced ERBB2/HER2-Positive Metastatic Breast Cancer: A Phase 1b Clinical Trial. JAMA Oncol. 2018 Sep 1;4(9):1214-1220. doi: 10.1001/jamaoncol.2018.1812.
PMID: 29955792DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Interventions

tucatinibAdo-Trastuzumab Emtansine

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

MaytansineMacrolidesLactonesOrganic ChemicalsLactams, Macrocyclic

Study Officials

JoAl Mayor, PharmD, BCOP
Seagen Inc.
STUDY DIRECTOR
Corinna Palanca-Wessels, MD, PhD
Seagen Inc.
STUDY DIRECTOR

Enrollment

57 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 1
Allocation: NA
Masking: NONE
Purpose: TREATMENT
Intervention Model: SINGLE GROUP
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

October 28, 2013

First Posted

November 14, 2013

Study Start

February 28, 2014

Actual (reported)

You may not qualify if:

Medical, social, or psychosocial factors that, in the opinion of the Investigator, could impact safety or compliance with study procedures.
Patient is breastfeeding.
Patient was treated with any experimental agent within 14 days or five half-lives of study treatment, whichever is greater.
Patient was treated with trastuzumab or other antibody based therapy within three weeks of starting study treatment or with chemotherapy or hormonal cancer therapy within two weeks of starting study treatment.
Patient had prior exposure to a cumulative dose of doxorubicin that exceeded 360 mg/m2 or its equivalent.
Previous treatment with T-DM1 at any time; or previous treatment with any small molecule HER2 inhibitors including (but not limited to) lapatinib, neratinib, or afatinib within the last 4 weeks prior to initiation of study therapy.
CNS disease:
Patients with leptomeningeal disease are excluded
Dose escalation and MTD/RP2D expansion cohort: Patients with symptomatic CNS metastases are excluded. Patients with treated CNS metastases or untreated asymptomatic CNS metastases not requiring immediate local therapy may be eligible. Enrollment of patients with metastases must be approved by the study medical monitor.
Optional CNS disease expansion cohort: Patients with asymptomatic untreated CNS metastases not needing immediate local therapy or patients with progressive CNS disease following local therapy may be eligible with medical monitor approval.
History of allergic reactions to compounds of similar chemical or biological composition to T-DM1 or tucatinib (ONT-380), except for a history of Grade 1 or Grade 2 Infusion Related Reaction to trastuzumab which has been successfully managed.
Patients with uncorrectable electrolyte abnormalities.
Known to be HIV positive. HIV testing is not required for those patients who are not known to be positive.
Known carrier of Hepatitis B and / or Hepatitis C (whether active disease or not).
Known liver disease, autoimmune hepatitis, or sclerosing cholangitis.
+6 more criteria

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (8)

Study Arms (1)

Tucatinib (ONT-380) in combination with T-DM1

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (11)

Related Publications (2)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (8)

Study Arms (1)

Tucatinib (ONT-380) in combination with T-DM1

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (11)

Related Publications (2)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations