Breast CancerPhase 1NCT04176757
A Study of ZN-c5 in Participants With Breast Cancer
A Phase 1 study testing ZN-c5 in people with Breast Cancer, run by Zeno Alpha Inc. at 10 sites in 3 countries.
Trial summary
This is a Phase 1 open-label, multicenter study to evaluate biomarkers for ZN-c5 in subjects with breast cancer Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer
- What is being tested?
- ZN-c5
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 10 sitesin 3 countries
- Study dates
- 3 Jan 2020to 25 May 2021
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 13Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
10 sites in 3 countries.
10 sites in 3 countries
United States5 sites
Site 1
Houston, Texas, 77030
Site 4
Nashville, Tennessee, 37240
Site 2
New York, New York, 10032
Site 5
Seattle, Washington, 98109
Site 3
Tucson, Arizona, 85719
Australia4 sites
Site 10
Cairns, Queensland, 4870
Site 11
Liverpool, New South Wales, 2170
Site 8
Richmond, Victoria, 3121
Site 9
Sydney, New South Wales, 2109
About this study
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
This is a Phase 1 open-label, multicenter study to evaluate biomarkers for ZN-c5 in subjects with breast cancer
- Conditions
- Breast Cancer
- Being tested
- ZN-c5
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZN-c5Drug
ZN-c5 study drug to be administered orally daily
| Study group | Role | What they receive |
|---|---|---|
| ZN-c5 | Experimental | Not described Receives: Drug: ZN-c5 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Corroborate the single agent Recommended Phase 2 Dose
Measured: Throughout the study, an average of 15 months
Secondary outcomes (3)
Dose-biomarker relationship
Percentage positive of Immunohistochemistry (IHC) staining Estrogen Receptor (ER) as compare to baseline
Measured: Throughout the study, an average of 15 months
Dose-biomarker relationship
Percentage positive of IHC staining Progesterone Receptor (PR) as compare to baseline
Measured: Throughout the study, an average of 15 months
Dose-biomarker relationship
Percentage positive of IHC staining Ki-67 as compare to baseline
Measured: Throughout the study, an average of 15 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2019
- Study start3 Jan 2020
- Primary completion27 Apr 2021
- Study completion25 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zeno Alpha Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mieke Ptaszynski, MD, Study director, Zeno Alpha Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04176757
- Sponsor's protocol ID
- ZN-c5-002
- Status last verified
- Apr 2022
- First submitted
- 15 Nov 2019
- Last updated
- 1 Aug 2022
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04176757
- Acronym / sponsor ID
- ZN-c5-002
- Conditions
- Breast Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Zeno Alpha Inc.Industry (pharma, biotech, devices)
- Study start
- 3 Jan 2020 (actual)
- Primary completion
- 27 Apr 2021 (actual)
- Study completion
- 25 May 2021 (actual)
- First posted
- 25 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a Phase 1 open-label, multicenter study to evaluate biomarkers for ZN-c5 in subjects with breast cancer
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ZN-c5 | Experimental | Drug: ZN-c5 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Signed and dated ICF
- Age ≥ 18 years of age, either gender
- Females must be postmenopausal as defined by at least one of the following:
- Histologically or cytologically confirmed diagnosis of adenocarcinoma of the breast
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ZN-c5ZN-c5 study drug to be administered orally daily | Drug | ZN-c5 |
Primary outcome
Corroborate the single agent Recommended Phase 2 Dose
Time frame: Throughout the study, an average of 15 months
3 secondary outcomes
Dose-biomarker relationship
Time frame: Throughout the study, an average of 15 months
Dose-biomarker relationship
Time frame: Throughout the study, an average of 15 months
Dose-biomarker relationship
Time frame: Throughout the study, an average of 15 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mieke Ptaszynski, MD study director
Zeno Alpha Inc.
10 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ZN-c5 in people with Breast Cancer, run by Zeno Alpha Inc. at 10 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States, Australia, Bosnia and Herzegovina. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Corroborate the single agent Recommended Phase 2 Dose (time frame: Throughout the study, an average of 15 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2022.