A Study of ZN-c5 in Participants With Breast Cancer

NCT ID: NCT04176757

Last Updated: 2022-08-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-01-03
• Study Completion Date: 2021-05-25

Brief Summary

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

Conditions

Breast Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

ZN-c5

Group Type: EXPERIMENTAL

ZN-c5

Intervention Type: DRUG

ZN-c5 study drug to be administered orally daily

Interventions

ZN-c5

ZN-c5 study drug to be administered orally daily

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zeno Alpha Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mieke Ptaszynski, MD

Role: STUDY_DIRECTOR

Zeno Alpha Inc.

Locations

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

Countries

United States; Australia; Bosnia and Herzegovina

Other Identifiers

ZN-c5-002

Identifier Type: -

Identifier Source: org_study_id