Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04176757




Registration number
NCT04176757
Ethics application status
Date submitted
15/11/2019
Date registered
25/11/2019
Date last updated
1/08/2022

Titles & IDs
Public title
A Study of ZN-c5 in Participants With Breast Cancer
Scientific 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
Secondary ID [1] 0 0
ZN-c5-002
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Breast Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Breast

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - ZN-c5

Experimental: ZN-c5 -


Treatment: Drugs: ZN-c5
ZN-c5 study drug to be administered orally daily
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Corroborate the single agent Recommended Phase 2 Dose
Assessment method [1] 0 0
Timepoint [1] 0 0
Throughout the study, an average of 15 months
Secondary outcome [1] 0 0
Dose-biomarker relationship
Assessment method [1] 0 0
Percentage positive of Immunohistochemistry (IHC) staining Estrogen Receptor (ER) as compare to baseline
Timepoint [1] 0 0
Throughout the study, an average of 15 months
Secondary outcome [2] 0 0
Dose-biomarker relationship
Assessment method [2] 0 0
Percentage positive of IHC staining Progesterone Receptor (PR) as compare to baseline
Timepoint [2] 0 0
Throughout the study, an average of 15 months
Secondary outcome [3] 0 0
Dose-biomarker relationship
Assessment method [3] 0 0
Percentage positive of IHC staining Ki-67 as compare to baseline
Timepoint [3] 0 0
Throughout the study, an average of 15 months

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
3/01/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
25/05/2021
Sample size
Target
Accrual to date
Final
35
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 0 0
Site 11 - Liverpool
Recruitment hospital [2] 0 0
Site 9 - Sydney
Recruitment hospital [3] 0 0
Site 10 - Cairns
Recruitment hospital [4] 0 0
Site 8 - Richmond
Recruitment postcode(s) [1] 0 0
2170 - Liverpool
Recruitment postcode(s) [2] 0 0
2109 - Sydney
Recruitment postcode(s) [3] 0 0
4870 - Cairns
Recruitment postcode(s) [4] 0 0
3121 - Richmond
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
New York
Country [3] 0 0
United States of America
State/province [3] 0 0
Tennessee
Country [4] 0 0
United States of America
State/province [4] 0 0
Texas
Country [5] 0 0
United States of America
State/province [5] 0 0
Washington
Country [6] 0 0
Bosnia and Herzegovina
State/province [6] 0 0
Banja Luka

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Zeno Alpha Inc.
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Public notes

Contacts
Principal investigator
Name 0 0
Mieke Ptaszynski, MD
Address 0 0
Zeno Alpha Inc.
Country 0 0
Phone 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT04176757