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Last Updated: June 29, 2022

CLINICAL TRIALS PROFILE FOR TUCATINIB


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All Clinical Trials for Tucatinib

Trial ID Title Status Sponsor Phase Start Date Summary
NCT01983501 ↗ A Study of Tucatinib (ONT-380) Combined With Ado-trastuzumab Emtansine (T-DM1) in Patients With HER2+ Breast Cancer Completed Cascadian Therapeutics Inc. Phase 1 2014-02-28 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.
NCT01983501 ↗ A Study of Tucatinib (ONT-380) Combined With Ado-trastuzumab Emtansine (T-DM1) in Patients With HER2+ Breast Cancer Completed Seagen Inc. Phase 1 2014-02-28 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.
NCT02025192 ↗ A Study of Tucatinib (ONT-380) Combined With Capecitabine and/or Trastuzumab in Patients With HER2+ Metastatic Breast Cancer Completed Cascadian Therapeutics Inc. Phase 1 2013-12-31 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.
NCT02025192 ↗ A Study of Tucatinib (ONT-380) Combined With Capecitabine and/or Trastuzumab in Patients With HER2+ Metastatic Breast Cancer Completed Seagen Inc. Phase 1 2013-12-31 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.
NCT02614794 ↗ A Study of Tucatinib vs. Placebo in Combination With Capecitabine & Trastuzumab in Patients With Advanced HER2+ Breast Cancer Active, not recruiting Cascadian Therapeutics Inc. Phase 2 2016-01-28 This study is being done to see if tucatinib works better than placebo to help patients who have a specific type of breast cancer called HER2 positive breast carcinoma. The breast cancer in this study is either metastatic (spread into other parts of the body) or cannot be removed completely with surgery. All patients in the study will get capecitabine and trastuzumab, two drugs that are often used to treat this cancer. There are two parts to this study. The first part of the study is already complete. Patients were randomly assigned to get either tucatinib or placebo (a pill with no medicine). Since this part was "blinded," neither patients nor their doctors knew whether a patient got tucatinib or placebo. The second part of the study is called the Unblinded Phase. In this part of the study, participants and their doctors know which drugs are being given. Participants who used to get or are currently getting placebo may be able to start taking tucatinib instead. Each treatment cycle lasts 21 days. Patients will swallow tucatinib pills two times every day. They will swallow capecitabine pills two times a day during the first two weeks of each cycle. Patients will get trastuzumab injections from the study site staff on the first day of every cycle.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Tucatinib

Condition Name

Condition Name for Tucatinib
Intervention Trials
Breast Cancer 7
HER2-positive Breast Cancer 5
Metastatic Breast Cancer 3
Healthy 3
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Condition MeSH

Condition MeSH for Tucatinib
Intervention Trials
Breast Neoplasms 24
Colorectal Neoplasms 6
Adenocarcinoma 6
Neoplasm Metastasis 4
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Clinical Trial Locations for Tucatinib

Trials by Country

Trials by Country for Tucatinib
Location Trials
United States 306
Canada 22
Japan 11
Korea, Republic of 7
Australia 7
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Trials by US State

Trials by US State for Tucatinib
Location Trials
Texas 18
California 17
Washington 14
Tennessee 13
Colorado 12
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Clinical Trial Progress for Tucatinib

Clinical Trial Phase

Clinical Trial Phase for Tucatinib
Clinical Trial Phase Trials
Phase 3 5
Phase 2/Phase 3 1
Phase 2 14
[disabled in preview] 19
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Clinical Trial Status

Clinical Trial Status for Tucatinib
Clinical Trial Phase Trials
Recruiting 14
Not yet recruiting 12
Completed 8
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Clinical Trial Sponsors for Tucatinib

Sponsor Name

Sponsor Name for Tucatinib
Sponsor Trials
Seagen Inc. 25
Seattle Genetics, Inc. 13
Cascadian Therapeutics Inc. 5
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Sponsor Type

Sponsor Type for Tucatinib
Sponsor Trials
Industry 61
Other 26
NIH 3
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