Breast Cancer
Conditions
Brief summary
This is a Phase 1 open-label, multicenter study to evaluate biomarkers for ZN-c5 in subjects with breast cancer
Interventions
DRUGZN-c5
ZN-c5 study drug to be administered orally daily
Sponsors
Zeno Alpha Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Corroborate the single agent Recommended Phase 2 Dose | Throughout the study, an average of 15 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Dose-biomarker relationship | Throughout the study, an average of 15 months | Percentage positive of Immunohistochemistry (IHC) staining Estrogen Receptor (ER) as compare to baseline |
Countries
Australia, Bosnia and Herzegovina, United States
Outcome results
None listed