A Study of ZN-c5 in Participants With Breast Cancer
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT04176757 |
Recruitment Status :
Recruiting
First Posted : November 25, 2019
Last Update Posted : January 20, 2021
|
Sponsor:
Zeno Alpha Inc.
Information provided by (Responsible Party):
Zeno Alpha Inc.
Tracking Information | |||||
---|---|---|---|---|---|
First Submitted Date ICMJE | November 15, 2019 | ||||
First Posted Date ICMJE | November 25, 2019 | ||||
Last Update Posted Date | January 20, 2021 | ||||
Actual Study Start Date ICMJE | January 3, 2020 | ||||
Estimated Primary Completion Date | December 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 |
|
||||
Original Secondary Outcome Measures ICMJE |
Dose-biomarker relationship [ Time Frame: Throughout the study, an average of 15 months ]
|
||||
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 |
||||
Condition ICMJE | Breast Cancer | ||||
Intervention ICMJE | Drug: ZN-c5
ZN-c5 study drug to be administered orally daily
|
||||
Study Arms ICMJE | Experimental: ZN-c5
Intervention: Drug: ZN-c5
|
||||
Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||
Recruitment Information | |||||
Recruitment Status ICMJE | Recruiting | ||||
Estimated Enrollment ICMJE |
36 | ||||
Original Estimated Enrollment ICMJE | Same as current | ||||
Estimated Study Completion Date ICMJE | April 2022 | ||||
Estimated Primary Completion Date | December 2021 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
||||
Sex/Gender ICMJE |
|
||||
Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE |
|
||||
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 |
|
||||
IPD Sharing Statement ICMJE |
|
||||
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 |
|
||||
PRS Account | Zeno Alpha Inc. | ||||
Verification Date | January 2021 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |