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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 : July 16, 2020
Sponsor:
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 July 16, 2020
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
 (submitted: November 21, 2019)
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
 (submitted: November 25, 2019)
  • Dose-biomarker relationship [ Time Frame: Throughout the study, an average of 15 months ]
    Percentage positive of Immunohistochemistry (IHC) staining Estrogen Receptor (ER) as compare to baseline
  • Dose-biomarker relationship [ Time Frame: Throughout the study, an average of 15 months ]
    Percentage positive of IHC staining Progesterone Receptor (PR) as compare to baseline
  • Dose-biomarker relationship [ Time Frame: Throughout the study, an average of 15 months ]
    Percentage positive of IHC staining Ki-67 as compare to baseline
Original Secondary Outcome Measures  ICMJE
 (submitted: November 21, 2019)
Dose-biomarker relationship [ Time Frame: Throughout the study, an average of 15 months ]
  • Percentage positive of Immunohistochemistry (IHC) staining Estrogen Receptor (ER) as compare to baseline
  • Percentage positive of IHC staining Progesterone Receptor (PR) as compare to baseline
  • Percentage positive of IHC staining Ki-67 as compare to baseline
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
 (submitted: November 21, 2019)
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:

  1. Signed and dated ICF
  2. Age ≥ 18 years of age, either gender
  3. Females must be postmenopausal as defined by at least one of the following:

    1. Age ≥ 60 years;
    2. 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 levels within the local laboratory's normal reference range for postmenopausal females;
    3. Documented bilateral oophorectomy
  4. Histologically or cytologically confirmed diagnosis of adenocarcinoma of the breast
  5. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
  6. Adequate organ function defined as follows:

    1. Hematologic: Platelets ≥ 100 × 109/L; Hemoglobin ≥ 9.0 g/dL; Absolute neutrophil count ≥ 1.5 × 109/L (without platelet transfusion or any hematopoietic growth factors within previous 7 days of the hematologic laboratory values obtained at the Screening Visit)
    2. Hepatic: Aspartate aminotransferase (AST) / Alanine aminotransferase (ALT)

      ≤ 2.5 × upper limit of normal (ULN); Total or conjugated bilirubin ≤ 1.5 × ULN

    3. Renal: Serum creatinine ≤ 1.5 × ULN or creatinine clearance (CrCl) ≥ 60 mL/min

Exclusion Criteria:

  1. Major surgery, defined as any surgical procedure that involves general anesthesia and a significant incision (i.e., larger than what is required for placement of central venous access, percutaneous feeding tube, or biopsy) within 28 days of the first administration of study drug
  2. Treatment with another investigational drug or other intervention within 28 days before the first administration of study drug
  3. Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of oral medication, including any unresolved nausea, vomiting, or diarrhea that is CTCAE v.5.0 Grade > 1
  4. Myocardial infarction, symptomatic congestive heart failure (New York Heart Association Classification > Class II), unstable angina, or serious uncontrolled cardiac arrhythmia within the last 6 months of study Day 1
  5. Uncontrolled inter-current illness
  6. History or evidence of clinically significant disorder, condition, or disease that, in the opinion of the Investigator would pose a risk to subject safety or interfere with the study evaluations, procedures, or completion
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: Mieke Ptaszynski, MD 8582634333 info@zenopharma.com
Listed Location Countries  ICMJE Bosnia and Herzegovina,   United States
Removed Location Countries  
 
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
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Zeno Alpha Inc.
Study Sponsor  ICMJE Zeno Alpha Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Mieke Ptaszynski, MD Zeno Alpha Inc.
PRS Account Zeno Alpha Inc.
Verification Date July 2020

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