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词条 ONT-380
释义

  1. Clinical trials

  2. References

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ONT-380 is a small molecule[1] HER2-selective tyrosine kinase inhibitor. It is an investigational drug for HER2-positive breast cancer.[2][3] Cascadian Therapeutics[4] has an exclusive license from Array BioPharma to manufacture, develop and commercialize ONT-380.

Clinical trials

Two early stage clinical trials have reported encouraging results; both of these studies had options to enroll patients with central nervous system (CNS) metastases.[2][5][6][7]

  • A Phase 1b, Open-label Study to Assess the Safety and Tolerability of ONT-380 Combined with Capecitabine and Trastuzumab, Alone and in Combination in HER2+ Metastatic Breast Cancer ([https://clinicaltrials.gov/ct2/show/NCT02025192 NCT02025192])[8]
  • A Phase 1b, Open-label Study to Assess the Safety and Tolerability of ONT-380 Combined With Ado-trastuzumab Emtansine (Trastuzumab Emtansine;T-DM1) ([https://clinicaltrials.gov/ct2/show/NCT01983501 NCT01983501])[9]

The HER2CLIMB study is currently open for enrollment. This clinical trial is a Phase 2 randomized, double-blinded, placebo-controlled study of ONT-380 in combination with Herceptin and Xeloda in patients with pretreated, unresectable locally advanced or metastatic HER2-positive breast cancer ([https://clinicaltrials.gov/ct2/show/NCT02614794 NCT02614794]).

References

1. ^[https://www.sciencedaily.com/releases/2015/05/150529131505.htm ONT-380 has stage IV HER2+ breast cancer patient 'worrying about normal stuff again'. May 2015]
2. ^ONT-380 Active Against CNS Mets in HER2-Positive Breast Cancer. Dec 2015
3. ^{{Cite journal|title=Emerging Therapeutic Options for HER2-Positive Breast Cancer|url=http://meetinglibrary.asco.org/content/159167-176|journal=Journal of Clinical Oncology|issn=0732-183X}}
4. ^{{Cite web|url=http://www.cascadianrx.com/|title=Cascadian Therapeutics|website=www.cascadianrx.com|access-date=2016-06-10}}
5. ^Oncothyreon Inc. (ONTY) Announces Data For ONT-380 In HER2-Positive Breast Cancer Patients With And Without Brain Metastases At The San Antonio Breast Cancer Symposium. Dec 2015 has detailed results
6. ^{{Cite web|url=http://abstracts.asco.org/176/AbstView_176_170543.html|title=Efficacy results of a phase 1b study of ont-380, a CNS-penetrant TKI, in combination with T-DM1 in HER2+ metastatic breast cancer (MBC), including patients (pts) with brain metastases. {{!}} 2016 ASCO Annual Meeting Abstracts|last=TN|first=Virginia F. Borges, Cristiano Ferrario, Nathalie Aucoin, Carla Isadora Falkson, Qamar J. Khan, Ian E. Krop, Stephen Welch, Philippe L. Bedard, Alison Katherine Conlin, Jorge Chaves, Luke N. Walker, Erika Paige Hamilton; University of Colorado Cancer Center, Aurora, CO; Segal Cancer Centre, Jewish General Hospital, Montreal, QC, Canada; Hôpital Cité de la Santé de Laval, Laval, QC, Canada; University of Alabama Comprehensive Cancer Center, Birmingham, AL; University of Kansas Medical Center, Kansas City, KS; Dana-Farber Cancer Institute, Boston, MA; London Regional Cancer Program, London, ON, Canada; Princess Margaret Cancer Centre Univ Health Network, Toronto, ON, Canada; Providence Cancer Center Oncology and Hematology Care Clinic, Portland, OR; Northwest Medical Specialties, Tacoma, WA; Oncothyreon, Seattle, WA; Sarah Cannon Research Institute/Tennessee Oncology, Brentwood,|website=Meeting Abstracts|access-date=2016-06-10}}
7. ^{{Cite web|url=http://www.coloradocancerblogs.org/ont-380-san-antonio/|title=SABCS15: Promising phase 1 results lead to phase 2 for ONT-380 in HER2+ breast cancer - Colorado Cancer Blogs|website=www.coloradocancerblogs.org|access-date=2016-06-10}}
8. ^{{Cite web|url=https://clinicaltrials.gov/ct2/show/NCT02025192|title=A Phase 1b Study of ONT-380 Combined With Capecitabine and/or Trastuzumab in Patients With HER2+ Metastatic Breast Cancer - Full Text View - ClinicalTrials.gov|website=clinicaltrials.gov|access-date=2016-06-10}}
9. ^{{Cite journal|title=Efficacy results of a phase 1b study of ont-380, a CNS-penetrant TKI, in combination with T-DM1 in HER2+ metastatic breast cancer (MBC), including patients (pts) with brain metastases.|url=http://meetinglibrary.asco.org/content/170543-176|journal=Journal of Clinical Oncology|issn=0732-183X}}
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3 : Cancer treatments|Tyrosine kinase inhibitors|Experimental drugs

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