A Study of ZN-c5 and Abemaciclib in Participants With Breast Cancer
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|ClinicalTrials.gov Identifier: NCT04514159|
Recruitment Status : Recruiting
First Posted : August 14, 2020
Last Update Posted : April 1, 2021
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Drug: ZN-c5 Drug: Abemaciclib||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||18 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||All participants will receive the same treatment but ZN-c5 will be given at different doses in this dose escalation study.|
|Masking:||None (Open Label)|
|Official Title:||A Phase 1b Study of ZN-c5 in Combination With Abemaciclib in Patients With Estrogen-Receptor Positive, Human Epidermal Growth Factor Receptor-2 Negative Advanced Breast Cancer|
|Actual Study Start Date :||November 12, 2020|
|Estimated Primary Completion Date :||April 2023|
|Estimated Study Completion Date :||December 2023|
Experimental: ZN-c5 + abemaciclib combination therapy
Participants will take abemaciclib (150mg) orally twice a day and ZN-c5 (dose escalation) orally once or twice a day to determine the safety, tolerability, and maximum tolerated dose (MTD) or recommended Phase 2 dose (RP2D).
ZN-c5 is the study drug.
Abemaciclib (VERZENIO®) is an approved drug.
Other Name: VERZENIO®
- Incidence and severity of adverse events from ZN-c5 in combination with abemaciclib [ Time Frame: Through study completion, anticipated to be 21 months ]Measured by the number of treatment-emergent adverse events and graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0
- Determine tumor responses to combination treatment [ Time Frame: Through study completion, anticipated to be 21 months ]Measured by radiographic responses as defined by revised Response Evaluation Criteria in Solid Tumor (RECIST) v1.1.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04514159
|Contact: Mieke Ptaszynski, MDemail@example.com|
|United States, Arizona|
|Gilbert, Arizona, United States, 85234|
|United States, New Jersey|
|Florham Park, New Jersey, United States, 07932|
|United States, South Carolina|
|Charleston, South Carolina, United States, 29414|
|Kraków, Poland, 30-348|
|Site 5||Not yet recruiting|
|Łódź, Poland, 93-513|
|Study Director:||Mieke Ptaszynski, MD||Zeno Alpha Inc.|