A Study of ZN-c5 in Participants With Breast Cancer

  • End date
    Apr 5, 2022
  • participants needed
  • sponsor
    Zeno Alpha Inc.
Updated on 5 November 2020
Zeno Pharmaceuticals
Primary Contact
Site 9 (1.3 mi away) Contact
+16 other location
breast adenocarcinoma


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

Treatment ZN-c5
Clinical Study IdentifierNCT04176757
SponsorZeno Alpha Inc.
Last Modified on5 November 2020

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Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have Breast Cancer?
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)
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

Exclusion Criteria

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
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Step 3 Enroll in the clinical study

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Step 4 Get your study results

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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