Clinical Trials /

A Study of ZN-c5 in Participants With Breast Cancer

NCT04176757

Description:

This is a Phase 1 open-label, multicenter study to evaluate biomarkers for ZN-c5 in subjects with breast cancer

Related Conditions:
  • Breast Adenocarcinoma
Recruiting Status:

Recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • 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

Clinical Trial IDs

  • ORG STUDY ID: ZN-c5-002
  • NCT ID: NCT04176757

Conditions

  • Breast Cancer

Interventions

DrugSynonymsArms
ZN-c5ZN-c5

Purpose

This is a Phase 1 open-label, multicenter study to evaluate biomarkers for ZN-c5 in subjects with breast cancer

Trial Arms

NameTypeDescriptionInterventions
ZN-c5Experimental
  • ZN-c5

Eligibility 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
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Corroborate the single agent Recommended Phase 2 Dose
Time Frame:Throughout the study, an average of 15 months
Safety Issue:
Description:

Secondary Outcome Measures

Measure:Dose-biomarker relationship
Time Frame:Throughout the study, an average of 15 months
Safety Issue:
Description:Percentage positive of Immunohistochemistry (IHC) staining Estrogen Receptor (ER) as compare to baseline
Measure:Dose-biomarker relationship
Time Frame:Throughout the study, an average of 15 months
Safety Issue:
Description:Percentage positive of IHC staining Progesterone Receptor (PR) as compare to baseline
Measure:Dose-biomarker relationship
Time Frame:Throughout the study, an average of 15 months
Safety Issue:
Description:Percentage positive of IHC staining Ki-67 as compare to baseline

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Not yet recruiting
Lead Sponsor:Zeno Alpha Inc.

Last Updated

November 25, 2019