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This is a Phase 1 open-label, multicenter study to evaluate biomarkers for ZN-c5 in subjects with breast cancer
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ZN-c5 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ZN-c5 | Drug | ZN-c5 study drug to be administered orally daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Corroborate the single agent Recommended Phase 2 Dose | Throughout the study, an average of 15 months |
| Measure | Description | Time Frame |
|---|---|---|
| Dose-biomarker relationship | Percentage positive of Immunohistochemistry (IHC) staining Estrogen Receptor (ER) as compare to baseline | Throughout the study, an average of 15 months |
| Dose-biomarker relationship |
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Inclusion Criteria:
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
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
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mieke Ptaszynski, MD | Zeno Alpha Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site 3 | Tucson | Arizona | 85719 | United States | ||
| Site 2 |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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Percentage positive of IHC staining Progesterone Receptor (PR) as compare to baseline
| Throughout the study, an average of 15 months |
| Dose-biomarker relationship | Percentage positive of IHC staining Ki-67 as compare to baseline | Throughout the study, an average of 15 months |
| New York |
| New York |
| 10032 |
| United States |
| Site 4 | Nashville | Tennessee | 37240 | United States |
| Site 1 | Houston | Texas | 77030 | United States |
| Site 5 | Seattle | Washington | 98109 | United States |
| Site 11 | Liverpool | New South Wales | 2170 | Australia |
| Site 9 | Sydney | New South Wales | 2109 | Australia |
| Site 10 | Cairns | Queensland | 4870 | Australia |
| Site 8 | Richmond | Victoria | 3121 | Australia |
| Site 7 | Banja Luka | 78000 | Bosnia and Herzegovina |
| D017437 |
| Skin and Connective Tissue Diseases |