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A Study of ZN-c5 and Abemaciclib 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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04514159
Recruitment Status : Active, not recruiting
First Posted : August 14, 2020
Last Update Posted : August 15, 2022
Sponsor:
Information provided by (Responsible Party):
Zeno Alpha Inc.

Tracking Information
First Submitted Date  ICMJE August 11, 2020
First Posted Date  ICMJE August 14, 2020
Last Update Posted Date August 15, 2022
Actual Study Start Date  ICMJE November 12, 2020
Estimated Primary Completion Date April 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 11, 2020)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 11, 2020)
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.
Original Secondary Outcome Measures  ICMJE Same as current
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 and Abemaciclib in Participants With Breast Cancer
Official Title  ICMJE 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
Brief Summary This is a Phase 1b, open-label, multicenter, dose-escalation study to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary efficacy of ZN-c5 administered orally in combination with abemaciclib (VERZENIO®) in participants with advanced estrogen-receptor positive, human epidermal growth factor receptor-2 negative (ER+/HER2-) 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
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)
Primary Purpose: Treatment
Condition  ICMJE Breast Cancer
Intervention  ICMJE
  • Drug: ZN-c5
    ZN-c5 is the study drug.
  • Drug: Abemaciclib
    Abemaciclib (VERZENIO®) is an approved drug.
    Other Name: VERZENIO®
Study Arms  ICMJE 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).
Interventions:
  • Drug: ZN-c5
  • Drug: Abemaciclib
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 Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: May 2, 2022)
14
Original Estimated Enrollment  ICMJE
 (submitted: August 11, 2020)
18
Estimated Study Completion Date  ICMJE December 2023
Estimated Primary Completion Date April 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Age ≥ 18 years of age
  • Women can be peri- or postmenopausal, as defined by at least one of the following:

    • Age ≥ 60 years;
    • Age < 60 years and cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause; and serum estradiol and follicle-stimulating hormone (FSH) level within the laboratory's reference range for postmenopausal females;
    • Documented bilateral oophorectomy;
    • Must receive a gonadotrophin-releasing hormone agonist beginning at least 4 weeks prior to the first dose of study medication
  • Histologically or cytologically confirmed diagnosis of advanced adenocarcinoma of the breast
  • Estrogen receptor positive disease
  • Human Epidermal Growth Factor Receptor 2 negative disease
  • Measurable disease per Response Evaluation Criteria in Solid Tumors v1.1

Exclusion Criteria:

  • Prior therapy within the following windows:

    • Tamoxifen, aromatase inhibitor, fulvestrant, or other anti-cancer endocrine therapy < 14 days;
    • Any investigational drug therapy < 28 days or 5 half-lives (whichever is shorter)
    • Any prior systemic chemotherapy regardless of the stop date, but the subject must have recovered to eligibility levels from prior toxicity
  • Prior treatment with CDK4/6 inhibitors
  • Unexplained symptomatic endometrial disorders (including, but not limited to, endometrial hyperplasia, dysfunctional uterine bleeding, or cysts)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
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 Poland,   United States
Removed Location Countries Bosnia and Herzegovina
 
Administrative Information
NCT Number  ICMJE NCT04514159
Other Study ID Numbers  ICMJE ZN-c5-003
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
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
Study Director: Andrew Henry Zeno Alpha Inc.
PRS Account Zeno Alpha Inc.
Verification Date August 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP