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History of Changes for Study: NCT04176757
A Study of ZN-c5 in Participants With Breast Cancer
Latest version (submitted July 28, 2022) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 November 21, 2019 None (earliest Version on record)
2 November 25, 2019 Outcome Measures and Study Status
3 December 28, 2019 Study Status
4 January 6, 2020 Recruitment Status, Study Status and Contacts/Locations
5 January 20, 2020 Contacts/Locations and Study Status
6 June 15, 2020 Contacts/Locations and Study Status
7 July 15, 2020 Study Status and Contacts/Locations
8 August 14, 2020 Contacts/Locations and Study Status
9 October 7, 2020 Contacts/Locations and Study Status
10 October 28, 2020 Contacts/Locations and Study Status
11 January 18, 2021 Contacts/Locations and Study Status
12 July 28, 2022 Recruitment Status, Study Status, Contacts/Locations and Study Design
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Study NCT04176757
Submitted Date:  November 21, 2019 (v1)

Open or close this module Study Identification
Unique Protocol ID: ZN-c5-002
Brief Title: A Study of ZN-c5 in Participants With Breast Cancer
Official Title: 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
Secondary IDs:
Open or close this module Study Status
Record Verification: November 2019
Overall Status: Not yet recruiting
Study Start: December 2019
Primary Completion: December 2021 [Anticipated]
Study Completion: April 2022 [Anticipated]
First Submitted: November 15, 2019
First Submitted that
Met QC Criteria:
November 21, 2019
First Posted: November 25, 2019 [Actual]
Last Update Submitted that
Met QC Criteria:
November 21, 2019
Last Update Posted: November 25, 2019 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: Zeno Alpha Inc.
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug: Yes
U.S. FDA-regulated Device: No
Data Monitoring:
Open or close this module Study Description
Brief Summary: This is a Phase 1 open-label, multicenter study to evaluate biomarkers for ZN-c5 in subjects with breast cancer
Detailed Description:
Open or close this module Conditions
Conditions: Breast Cancer
Keywords:
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 1
Interventional Study Model: Single Group Assignment
Number of Arms: 1
Masking: None (Open Label)
Allocation: N/A
Enrollment: 36 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: ZN-c5 Drug: ZN-c5
ZN-c5 study drug to be administered orally daily
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Corroborate the single agent Recommended Phase 2 Dose
[ Time Frame: Throughout the study, an average of 15 months ]

Secondary Outcome Measures:
1. 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
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

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
Open or close this module Contacts/Locations
Central Contact Person: Mieke Ptaszynski, MD
Telephone: 8582634333
Email: info@zenopharma.com
Study Officials: Mieke Ptaszynski, MD
Study Director
Zeno Alpha Inc.
Locations: United States, Arizona
Site 3
Tucson, Arizona, United States, 85719
United States, New York
Site 2
New York, New York, United States, 10032
United States, Tennessee
Site 4
Nashville, Tennessee, United States, 37240
United States, Texas
Site 1
Houston, Texas, United States, 77030
United States, Washington
Site 5
Seattle, Washington, United States, 98109
Open or close this module IPDSharing
Plan to Share IPD: No
Open or close this module References
Citations:
Links:
Available IPD/Information:

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