Description:
This is a Phase 1 open-label, multicenter study to evaluate biomarkers for ZN-c5 in subjects
with breast cancer
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
Interventions
Drug | Synonyms | Arms |
---|
ZN-c5 | | ZN-c5 |
Purpose
This is a Phase 1 open-label, multicenter study to evaluate biomarkers for ZN-c5 in subjects
with breast cancer
Trial Arms
Name | Type | Description | Interventions |
---|
ZN-c5 | Experimental | | |
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: | Recruiting |
Lead Sponsor: | Zeno Alpha Inc. |
Last Updated
January 20, 2021