Breast Cancer Clinical Trial

A Study of ZN-c5 in Subjects With Breast Cancer

Summary

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®).

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

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 FSH level within the laboratory's reference range for postmenopausal females;
Documented bilateral oophorectomy;
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 (SD, PR, or CR 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.

Exclusion Criteria:

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)

Study is for people with:

Breast Cancer

Phase:

Phase 1

Estimated Enrollment:

181

Study ID:

NCT03560531

Recruitment Status:

Active, not recruiting

Sponsor:

Zeno Alpha Inc.

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There are 37 Locations for this study

See Locations Near You

Site 3
Tucson Arizona, 85719, United States
Site 5
Los Angeles California, 91010, United States
Site 48
Bethesda Maryland, 20817, United States
Site 47
Saint Louis Missouri, 63110, United States
Site 7
New York New York, 10029, United States
Site 2
New York New York, 10032, United States
Site 50
Charleston South Carolina, 29414, United States
Site 4
Nashville Tennessee, 37240, United States
Site 1
Houston Texas, 77030, United States
Site 8
Houston Texas, 77030, United States
Site 6
Seattle Washington, 98195, United States
Site 46
Minsk , 22304, Belarus
Site 45
Vitebsk , 21060, Belarus
Site 10
Banja Luka , 78000, Bosnia and Herzegovina
Site 9
Sarajevo , 71000, Bosnia and Herzegovina
Site 11
Tuzla , 75000, Bosnia and Herzegovina
Site 29
Brno , 65653, Czechia
Site 28
Olomouc , 77900, Czechia
Site 30
Praha 5 , 15006, Czechia
Site 51
Budapest , H-106, Hungary
Site 35
Kecskemét , H-600, Hungary
Site 37
Pécs , H-762, Hungary
Site 17
Kaunas , 50161, Lithuania
Site 16
Vilnius , 08660, Lithuania
Site 42
Ekaterinburg , 62003, Russian Federation
Site 40
Nizhniy Novgorod , 60308, Russian Federation
Site 52
Omsk , 64401, Russian Federation
Site 41
Pyatigorsk , 35750, Russian Federation
Site 39
Saint Petersburg , 19702, Russian Federation
Site 18
Belgrade , 11000, Serbia
Site 19
Belgrade , 11080, Serbia
Site 21
Niš , 18000, Serbia
Site 20
Novi Sad , 21204, Serbia
Site 25
Cherkasy , 18009, Ukraine
Site 27
Kharkiv , 61070, Ukraine
Site 24
Kropyvnytskyi , 25006, Ukraine
Site 26
Kryvyi Rih , 50048, Ukraine
Site 23
Kyiv , 03115, Ukraine

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Phase:

Phase 1

Estimated Enrollment:

181

Study ID:

NCT03560531

Recruitment Status:

Active, not recruiting

Sponsor:


Zeno Alpha Inc.

How clear is this clinincal trial information?

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