Clinical trial NCT04176757: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Breast Cancer
Lead sponsor: Zeno Alpha Inc.
Sponsor class: INDUSTRY
First posted: 2019-11-25
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


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

Primary outcomes:
measure: Corroborate the single agent Recommended Phase 2 Dose
timeFrame: Throughout the study, an average of 15 months
Secondary outcomes:
measure: Dose-biomarker relationship
timeFrame: Throughout the study, an average of 15 months
measure: Dose-biomarker relationship
timeFrame: Throughout the study, an average of 15 months
measure: Dose-biomarker relationship
timeFrame: Throughout the study, an average of 15 months
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Site 3
state: Arizona
city: New York
country: United States
facility: Site 2
state: New York
city: Nashville
country: United States
facility: Site 4
state: Tennessee
city: Houston
country: United States
facility: Site 1
state: Texas
city: Seattle
country: United States
facility: Site 5
state: Washington
city: Liverpool
country: Australia
facility: Site 11
state: New South Wales
city: Sydney
country: Australia
facility: Site 9
state: New South Wales
city: Cairns
country: Australia
facility: Site 10
state: Queensland
city: Richmond
country: Australia
facility: Site 8
state: Victoria
city: Banja Luka
country: Bosnia and Herzegovina
facility: Site 7
Study officials:
affiliation: Zeno Alpha Inc.
name: Mieke Ptaszynski, MD
role: STUDY_DIRECTOR
References: