A Study of ZN-c5 in Participants With Breast Cancer

Completed · Phase 1

Conditions studied: Breast Cancer

In brief

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

Key facts

Study ID

NCT04176757

Run by

Zeno Alpha Inc.

People needed

35

Starts

2020-01-03

Expected to finish

2021-05-25

Last updated by the study team

2022-08-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Signed and dated ICF
• Age ≥ 18 years of age, either gender
• Females must be postmenopausal as defined by at least one of the following:
• Age ≥ 60 years;
• 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;
• Documented bilateral oophorectomy
• Histologically or cytologically confirmed diagnosis of adenocarcinoma of the breast
• Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
• Adequate organ function defined as follows:
• 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)
• Hepatic: Aspartate aminotransferase (AST) / Alanine aminotransferase (ALT)
• ≤ 2.5 × upper limit of normal (ULN); Total or conjugated bilirubin ≤ 1.5 × ULN
• Renal: Serum creatinine ≤ 1.5 × ULN or creatinine clearance (CrCl) ≥ 60 mL/min

You may not qualify if…

• 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
• Treatment with another investigational drug or other intervention within 28 days before the first administration of study drug
• 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
• 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
• Uncontrolled inter-current illness
• 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

Where it is running

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

Full record on ClinicalTrials.gov

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