MedPath

Tucatinib

Generic Name
Tucatinib
Brand Names
Tukysa
Drug Type
Small Molecule
Chemical Formula
C26H24N8O2
CAS Number
937263-43-9
Unique Ingredient Identifier
234248D0HH
Background

Tucatinib is a kinase inhibitor drug used with trastuzumab and capecitabine in the treatment of unresectable or metastatic HER-2 positive breast cancer. It was developed by Seattle Genetics and approved by the FDA on April 17, 2020. Tucatinib is a promising new treatment for patients with metastatic breast cancer who have not responded adequately to other chemotherapy regimens.

Indication

本品与曲妥珠单抗和卡培他滨联用治疗人类表皮生长因子受体2(HER2)阳性且已出现转移(如脑转移)或无法进行乳房切除术的乳腺癌成人患者,患者应接受过一种或多种抗HER2乳腺癌药物治疗。

Associated Conditions
Breast Cancer, Unresectable Breast Cancer, Wild-type RAS Metastatic Colorectal Cancer, Unresectable RAS Wild Type Colorectal Cancer

Tucatinib, Palbociclib and Letrozole in Metastatic Hormone Receptor Positive and HER2-positive Breast Cancer

Phase 1
Completed
Conditions
Breast Cancer
Interventions
First Posted Date
2017-02-15
Last Posted Date
2023-11-13
Lead Sponsor
University of Colorado, Denver
Target Recruit Count
42
Registration Number
NCT03054363
Locations
🇺🇸

University of Texas Health Science Center San Antonio, San Antonio, Texas, United States

🇺🇸

University of Arizona, Tucson, Arizona, United States

🇺🇸

University of Colorado Denver, Aurora, Colorado, United States

and more 3 locations

Tucatinib Plus Trastuzumab in Patients With HER2+ Colorectal Cancer

Phase 2
Completed
Conditions
Metastatic Colorectal Adenocarcinoma
Interventions
First Posted Date
2017-02-06
Last Posted Date
2024-11-26
Lead Sponsor
Seagen Inc.
Target Recruit Count
117
Registration Number
NCT03043313
Locations
🇺🇸

Texas Oncology - Beaumont, Beaumont, Texas, United States

🇺🇸

Lombardi Cancer Center / Georgetown University Medical Center, Washington, District of Columbia, United States

🇪🇸

Hospital General Universitario Gregorio Maranon, Madrid, Other, Spain

and more 53 locations

Trial of ZW25 (Zanidatamab) in Patients With Advanced HER2-expressing Cancers

Phase 1
Completed
Conditions
HER2-expressing Cancers
Interventions
First Posted Date
2016-09-08
Last Posted Date
2024-11-27
Lead Sponsor
Jazz Pharmaceuticals
Target Recruit Count
279
Registration Number
NCT02892123
Locations
🇺🇸

Hoag Family Cancer Institute, Newport Beach, California, United States

🇺🇸

MD Anderson Cancer Center, Houston, Texas, United States

🇺🇸

Rush University Medical Center, Chicago, Illinois, United States

and more 14 locations

TAPUR: Testing the Use of Food and Drug Administration (FDA) Approved Drugs That Target a Specific Abnormality in a Tumor Gene in People With Advanced Stage Cancer

First Posted Date
2016-02-26
Last Posted Date
2025-05-06
Lead Sponsor
American Society of Clinical Oncology
Target Recruit Count
4200
Registration Number
NCT02693535
Locations
🇺🇸

University of Alabama at Birmingham Comprehensive Cancer Center, Birmingham, Alabama, United States

🇺🇸

Cancer Treatment Centers of America-Phoenix, Phoenix, Arizona, United States

🇺🇸

Sutter Auburn, Auburn, California, United States

and more 129 locations

A Study of Tucatinib vs. Placebo in Combination With Capecitabine & Trastuzumab in Patients With Advanced HER2+ Breast Cancer

Phase 2
Completed
Conditions
HER2 Positive Breast Cancer
Interventions
First Posted Date
2015-11-25
Last Posted Date
2023-08-14
Lead Sponsor
Seagen Inc.
Target Recruit Count
612
Registration Number
NCT02614794
Locations
🇺🇸

Carle Cancer Center, Urbana, Illinois, United States

🇺🇸

University of Kansas Cancer Center, Westwood, Kansas, United States

🇺🇸

Paris Regional Medical Center / US Oncology, Paris, Texas, United States

and more 173 locations

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

Phase 1
Completed
Conditions
HER2 Positive Metastatic Breast Cancers
Interventions
First Posted Date
2013-12-31
Last Posted Date
2020-06-04
Lead Sponsor
Seagen Inc.
Target Recruit Count
60
Registration Number
NCT02025192
Locations
🇺🇸

University of Colorado, Aurora, Colorado, United States

🇺🇸

Northwest Medical Specialties, Tacoma, Washington, United States

🇺🇸

Providence Cancer Center, Portland, Oregon, United States

and more 2 locations

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

Phase 1
Completed
Conditions
HER2 Positive Breast Cancers
Interventions
First Posted Date
2013-11-14
Last Posted Date
2020-09-21
Lead Sponsor
Seagen Inc.
Target Recruit Count
57
Registration Number
NCT01983501
Locations
🇨🇦

Princess Margaret Cancer Centre, Toronto, Ontario, Canada

🇨🇦

Hospital de la Cite-de-la-Sante, Laval, Quebec, Canada

🇺🇸

Sarah Cannon Research Institute, Nashville, Tennessee, United States

and more 8 locations

I-SPY TRIAL: Neoadjuvant and Personalized Adaptive Novel Agents to Treat Breast Cancer

Phase 2
Recruiting
Conditions
HER2-negative Breast Cancer
Hormone Receptor Positive Tumor
Angiosarcoma
TNBC - Triple-Negative Breast Cancer
Breast Neoplasms
Breast Tumors
HER2-positive Breast Cancer
Hormone Receptor Negative Tumor
Breast Cancer
Early-stage Breast Cancer
Interventions
First Posted Date
2010-01-05
Last Posted Date
2024-10-22
Lead Sponsor
QuantumLeap Healthcare Collaborative
Target Recruit Count
5000
Registration Number
NCT01042379
Locations
🇺🇸

Rutgers Cancer Institute of New Jersey, New Brunswick, New Jersey, United States

🇺🇸

University of Texas, Southwestern Medical Center, Dallas, Texas, United States

🇺🇸

University of Kansas, Westwood, Kansas, United States

and more 33 locations
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