A Study of ZN-c5 in Participants With Breast Cancer

Breast Cancer Clinical Trial

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 Details — Status: Completed

Administrative data

• NCT number: NCT04176757
• Other study ID #: ZN-c5-002
• Status: Completed
• Phase: Phase 1
• Start date: January 3, 2020
• Est. completion date: May 25, 2021

Study information

• Verified date: April 2022
• Source: Zeno Alpha Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: May 25, 2021
• Est. primary completion date: April 27, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• ZN-c5
ZN-c5 study drug to be administered orally daily

Locations

Country	Name	City	State
Australia	Site 10	Cairns	Queensland
Australia	Site 11	Liverpool	New South Wales
Australia	Site 8	Richmond	Victoria
Australia	Site 9	Sydney	New South Wales
Bosnia and Herzegovina	Site 7	Banja Luka
United States	Site 1	Houston	Texas
United States	Site 4	Nashville	Tennessee
United States	Site 2	New York	New York
United States	Site 5	Seattle	Washington
United States	Site 3	Tucson	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Zeno Alpha Inc.

Countries where clinical trial is conducted

United States,  Australia,  Bosnia and Herzegovina, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Corroborate the single agent Recommended Phase 2 Dose		Throughout the study, an average of 15 months
Secondary	Dose-biomarker relationship	Percentage positive of Immunohistochemistry (IHC) staining Estrogen Receptor (ER) as compare to baseline	Throughout the study, an average of 15 months
Secondary	Dose-biomarker relationship	Percentage positive of IHC staining Progesterone Receptor (PR) as compare to baseline	Throughout the study, an average of 15 months
Secondary	Dose-biomarker relationship	Percentage positive of IHC staining Ki-67 as compare to baseline	Throughout the study, an average of 15 months