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A Study of ZN-c5 in Participants With Breast Cancer

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 evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04176757
Recruitment Status : Recruiting
First Posted : November 25, 2019
Last Update Posted : July 16, 2020
Sponsor:
Information provided by (Responsible Party):
Zeno Alpha Inc.

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
Breast Cancer Drug: ZN-c5 Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 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 : January 3, 2020
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : April 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Experimental: ZN-c5 Drug: ZN-c5
ZN-c5 study drug to be administered orally daily




Primary Outcome Measures :
  1. Corroborate the single agent Recommended Phase 2 Dose [ Time Frame: Throughout the study, an average of 15 months ]

Secondary Outcome Measures :
  1. Dose-biomarker relationship [ Time Frame: 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 [ Time Frame: Throughout the study, an average of 15 months ]
    Percentage positive of IHC staining Progesterone Receptor (PR) as compare to baseline

  3. Dose-biomarker relationship [ Time Frame: Throughout the study, an average of 15 months ]
    Percentage positive of IHC staining Ki-67 as compare to baseline



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04176757


Contacts
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Contact: Mieke Ptaszynski, MD 8582634333 info@zenopharma.com

Locations
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United States, Arizona
Site 3 Recruiting
Tucson, Arizona, United States, 85719
United States, New York
Site 2 Recruiting
New York, New York, United States, 10032
United States, Tennessee
Site 4 Recruiting
Nashville, Tennessee, United States, 37240
United States, Texas
Site 1 Recruiting
Houston, Texas, United States, 77030
United States, Washington
Site 5 Recruiting
Seattle, Washington, United States, 98109
Bosnia and Herzegovina
Univ. Clinical Centre of the Republic of Srpska Clinic of Oncology Not yet recruiting
Banja Luka, Bosnia and Herzegovina
Contact: Zivko Vranjes, MD         
Clinical Centre University of Sarajevo Oncolgy Clinic Not yet recruiting
Sarajevo, Bosnia and Herzegovina
Contact: Semir Beslija, MD         
Sponsors and Collaborators
Zeno Alpha Inc.
Investigators
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Study Director: Mieke Ptaszynski, MD Zeno Alpha Inc.
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Responsible Party: Zeno Alpha Inc.
ClinicalTrials.gov Identifier: NCT04176757    
Other Study ID Numbers: ZN-c5-002
First Posted: November 25, 2019    Key Record Dates
Last Update Posted: July 16, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases