A Study of ZN-c5 in Subjects With Breast Cancer
Completed · Phase 1/Phase 2
Conditions studied: Breast Cancer
In brief
This is a Phase 1/2, open-label, multicenter, dose-escalation and expansion study to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of ZN-c5 administered orally in subjects with advanced estrogen receptor positive, human epidermal growth factor receptor 2 negative (ER+/HER2-) breast cancer. ZN-c5 will be evaluated both as monotherapy and in combination with palbociclib (IBRANCE®).
Key facts
- Study ID
- NCT03560531
- Run by
- Zeno Alpha Inc.
- People needed
- 181
- Starts
- 2018-11-30
- Expected to finish
- 2022-12-22
- Last updated by the study team
- 2024-08-09
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Age ≥ 18 years of age
- Women can 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 level within the laboratory's reference range for postmenopausal females;
- Documented bilateral oophorectomy; or can be peri- or premenopausal, however, they must receive a gonadotrophin-releasing hormone agonist beginning at least 4 weeks prior to the first dose of study medication.
- Histologically or cytologically confirmed diagnosis of advanced (metastatic or locoregionally recurrent) adenocarcinoma of the breast, not amenable to any potential curative intervention
- Estrogen Receptor (ER) positive disease
- Human Epidermal Growth Factor Receptor 2 (HER2) negative disease
- Documented prior response to endocrine therapy for metastatic disease (stable disease, partial response, or complete response by RECIST v1.1 criteria) lasting > 6 months
- Evaluable or measurable disease by RECIST v1.1. Tumor lesions previously irradiated or subjected to other locoregional therapy will only be deemed measurable if progression at the treated site after completion of therapy is clearly documented.
You may not qualify if…
- Prior anticancer or investigational drugs for the treatment of ER+/HER2 negative advanced breast cancer within the following windows:
- Tamoxifen, aromatase inhibitor, fulvestrant, or other anti-cancer endocrine therapy < 14 days before first dose of study treatment
- Any chemotherapy < 28 days before first dose of study, except for Phase 2 monotherapy which requires no prior chemotherapy treatment.
- Any investigational drug therapy < 28 days or 5 half-lives (whichever is shorter) prior to first dose of study treatment
- Unexplained symptomatic endometrial disorders (including, but not limited to endometrial hyperplasia, dysfunctional uterine bleeding, or cysts)
Where it is running
- Site 3 — Tucson, Arizona, United States
- Site 5 — Los Angeles, California, United States
- Site 48 — Bethesda, Maryland, United States
- Site 47 — St Louis, Missouri, United States
- Site 7 — New York, New York, United States
- Site 2 — New York, New York, United States
- Site 50 — Charleston, South Carolina, United States
- Site 4 — Nashville, Tennessee, United States
- Site 1 — Houston, Texas, United States
- Site 8 — Houston, Texas, United States
- Site 6 — Seattle, Washington, United States
- Site 46 — Minsk, Belarus
- Site 45 — Vitebsk, Belarus
- Site 10 — Banja Luka, Bosnia and Herzegovina
- Site 9 — Sarajevo, Bosnia and Herzegovina
- Site 11 — Tuzla, Bosnia and Herzegovina
- Site 29 — Brno, Czechia
- Site 28 — Olomouc, Czechia
- Site 30 — Prague, Czechia
- Site 51 — Budapest, Hungary
- Site 35 — Kecskemét, Hungary
- Site 37 — Pécs, Hungary
- Site 17 — Kaunas, Lithuania
- Site 16 — Vilnius, Lithuania
- Site 40 — Nizhny Novgorod, Russia
Full record on ClinicalTrials.gov
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