A Study of ZN-c5 in Participants With Breast Cancer
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ClinicalTrials.gov Identifier: NCT04176757 |
Recruitment Status :
Completed
First Posted : November 25, 2019
Last Update Posted : August 1, 2022
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Sponsor:
Zeno Alpha Inc.
Information provided by (Responsible Party):
Zeno Alpha Inc.
Tracking Information | |||||
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First Submitted Date ICMJE | November 15, 2019 | ||||
First Posted Date ICMJE | November 25, 2019 | ||||
Last Update Posted Date | August 1, 2022 | ||||
Actual Study Start Date ICMJE | January 3, 2020 | ||||
Actual Primary Completion Date | April 27, 2021 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
Corroborate the single agent Recommended Phase 2 Dose [ Time Frame: Throughout the study, an average of 15 months ] | ||||
Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | |||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
Dose-biomarker relationship [ Time Frame: Throughout the study, an average of 15 months ]
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Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | A Study of ZN-c5 in Participants With Breast Cancer | ||||
Official Title ICMJE | A Phase 1 Open-Label, Multicenter Study to Evaluate Biomarkers for ZN-c5 in Subjects With Estrogen Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative Breast Cancer | ||||
Brief Summary | This is a Phase 1 open-label, multicenter study to evaluate biomarkers for ZN-c5 in subjects with breast cancer | ||||
Detailed Description | Not Provided | ||||
Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 1 | ||||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Breast Cancer | ||||
Intervention ICMJE | Drug: ZN-c5
ZN-c5 study drug to be administered orally daily
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Study Arms ICMJE | Experimental: ZN-c5
Intervention: Drug: ZN-c5
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Completed | ||||
Actual Enrollment ICMJE |
35 | ||||
Original Estimated Enrollment ICMJE |
36 | ||||
Actual Study Completion Date ICMJE | May 25, 2021 | ||||
Actual Primary Completion Date | April 27, 2021 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | Australia, Bosnia and Herzegovina, United States | ||||
Removed Location Countries | Bulgaria, Hong Kong, Serbia | ||||
Administrative Information | |||||
NCT Number ICMJE | NCT04176757 | ||||
Other Study ID Numbers ICMJE | ZN-c5-002 | ||||
Has Data Monitoring Committee | Not Provided | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Current Responsible Party | Zeno Alpha Inc. | ||||
Original Responsible Party | Same as current | ||||
Current Study Sponsor ICMJE | Zeno Alpha Inc. | ||||
Original Study Sponsor ICMJE | Same as current | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE |
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PRS Account | Zeno Alpha Inc. | ||||
Verification Date | April 2022 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |