NCT04176757

Brief Summary

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

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at P25-P50 for phase_1 breast-cancer

Timeline
Completed

Started Jan 2020

Shorter than P25 for phase_1 breast-cancer

Geographic Reach
3 countries

10 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 15, 2019

Completed
10 days until next milestone

First Posted

Study publicly available on registry

November 25, 2019

Completed
1 month until next milestone

Study Start

First participant enrolled

January 3, 2020

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 27, 2021

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 25, 2021

Completed
Last Updated

August 1, 2022

Status Verified

April 1, 2022

Enrollment Period

1.3 years

First QC Date

November 15, 2019

Last Update Submit

July 28, 2022

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

  • Corroborate the single agent Recommended Phase 2 Dose

    Throughout the study, an average of 15 months

Secondary Outcomes (3)

  • Dose-biomarker relationship

    Throughout the study, an average of 15 months

  • Dose-biomarker relationship

    Throughout the study, an average of 15 months

  • Dose-biomarker relationship

    Throughout the study, an average of 15 months

Study Arms (1)

ZN-c5

EXPERIMENTAL
Drug: ZN-c5

Interventions

ZN-c5DRUG

ZN-c5 study drug to be administered orally daily

ZN-c5

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Site 3

Tucson, Arizona, 85719, United States

Location

Site 2

New York, New York, 10032, United States

Location

Site 4

Nashville, Tennessee, 37240, United States

Location

Site 1

Houston, Texas, 77030, United States

Location

Site 5

Seattle, Washington, 98109, United States

Location

Site 11

Liverpool, New South Wales, 2170, Australia

Location

Site 9

Sydney, New South Wales, 2109, Australia

Location

Site 10

Cairns, Queensland, 4870, Australia

Location

Site 8

Richmond, Victoria, 3121, Australia

Location

Site 7

Banja Luka, 78000, Bosnia and Herzegovina

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Mieke Ptaszynski, MD

    Zeno Alpha Inc.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 15, 2019

First Posted

November 25, 2019

Study Start

January 3, 2020

Primary Completion

April 27, 2021

Study Completion

May 25, 2021

Last Updated

August 1, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share

Locations

US(5)AU(4)BO(1)