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A Study of ZN-c5 in Participants With Breast Cancer

Sponsor
Zeno Alpha Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT04176757
Collaborator
(none)
35
Enrollment
10
Locations
1
Arm
16.7
Actual Duration (Months)
3.5
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
35 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Jan 3, 2020
Actual Primary Completion Date :
Apr 27, 2021
Actual Study Completion Date :
May 25, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: ZN-c5

Drug: ZN-c5
ZN-c5 study drug to be administered orally daily

Outcome Measures

Primary Outcome Measures

  1. Corroborate the single agent Recommended Phase 2 Dose [Throughout the study, an average of 15 months]

Secondary Outcome Measures

  1. Dose-biomarker relationship [Throughout the study, an average of 15 months]

    Percentage positive of Immunohistochemistry (IHC) staining Estrogen Receptor (ER) as compare to baseline

  2. Dose-biomarker relationship [Throughout the study, an average of 15 months]

    Percentage positive of IHC staining Progesterone Receptor (PR) as compare to baseline

  3. Dose-biomarker relationship [Throughout the study, an average of 15 months]

    Percentage positive of IHC staining Ki-67 as compare to baseline

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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:

  4. Age ≥ 60 years;

  5. 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;

  6. Documented bilateral oophorectomy

  7. Histologically or cytologically confirmed diagnosis of adenocarcinoma of the breast

  8. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1

  9. Adequate organ function defined as follows:

  10. 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)

  11. Hepatic: Aspartate aminotransferase (AST) / Alanine aminotransferase (ALT)

≤ 2.5 × upper limit of normal (ULN); Total or conjugated bilirubin ≤ 1.5 × ULN

  1. 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Site 3 Tucson Arizona United States 85719
2 Site 2 New York New York United States 10032
3 Site 4 Nashville Tennessee United States 37240
4 Site 1 Houston Texas United States 77030
5 Site 5 Seattle Washington United States 98109
6 Site 11 Liverpool New South Wales Australia 2170
7 Site 9 Sydney New South Wales Australia 2109
8 Site 10 Cairns Queensland Australia 4870
9 Site 8 Richmond Victoria Australia 3121
10 Site 7 Banja Luka Bosnia and Herzegovina 78000

Sponsors and Collaborators

  • Zeno Alpha Inc.

Investigators

  • Study Director: Mieke Ptaszynski, MD, Zeno Alpha Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Zeno Alpha Inc.
ClinicalTrials.gov Identifier:
NCT04176757
Other Study ID Numbers:
  • ZN-c5-002
First Posted:
Nov 25, 2019
Last Update Posted:
Aug 1, 2022
Last Verified:
Apr 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Breast Neoplasms

Study Results

No Results Posted as of Aug 1, 2022