A Study of ZN-c5 in Subjects With Breast Cancer

Breast Cancer Clinical Trial

Official title:

A Phase 1/2 Open Label, Multicenter Study to Assess the Safety, Tolerability, Pharmacokinetics, and Anti-Tumor Activity of ZN-c5 Alone and in Combination With Palbociclib in Subjects With Estrogen-Receptor Positive, Human Epidermal Growth Factor Receptor-2 Negative Advanced Breast Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03560531
• Other study ID #: ZN-c5-001
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: December 8, 2018
• Est. completion date: December 22, 2022

Study information

• Verified date: February 2023
• Source: Zeno Alpha Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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®).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 181
• Est. completion date: December 22, 2022
• Est. primary completion date: April 26, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• ZN-c5
ZN-c5 is a study drug
• Palbociclib
Palbociclib (IBRANCE®) is an approved drug

Locations

Country	Name	City	State
Belarus	Site 46	Minsk
Belarus	Site 45	Vitebsk
Bosnia and Herzegovina	Site 10	Banja Luka
Bosnia and Herzegovina	Site 9	Sarajevo
Bosnia and Herzegovina	Site 11	Tuzla
Czechia	Site 29	Brno
Czechia	Site 28	Olomouc
Czechia	Site 30	Praha 5
Hungary	Site 51	Budapest
Hungary	Site 35	Kecskemét
Hungary	Site 37	Pécs
Lithuania	Site 17	Kaunas
Lithuania	Site 16	Vilnius
Russian Federation	Site 42	Ekaterinburg
Russian Federation	Site 40	Nizhniy Novgorod
Russian Federation	Site 52	Omsk
Russian Federation	Site 41	Pyatigorsk
Russian Federation	Site 39	Saint Petersburg
Serbia	Site 18	Belgrade
Serbia	Site 19	Belgrade
Serbia	Site 21	Niš
Serbia	Site 20	Novi Sad
Ukraine	Site 25	Cherkasy
Ukraine	Site 27	Kharkiv
Ukraine	Site 24	Kropyvnytskyi
Ukraine	Site 26	Kryvyi Rih
Ukraine	Site 23	Kyiv
United States	Site 48	Bethesda	Maryland
United States	Site 50	Charleston	South Carolina
United States	Site 1	Houston	Texas
United States	Site 8	Houston	Texas
United States	Site 5	Los Angeles	California
United States	Site 4	Nashville	Tennessee
United States	Site 2	New York	New York
United States	Site 7	New York	New York
United States	Site 47	Saint Louis	Missouri
United States	Site 6	Seattle	Washington
United States	Site 3	Tucson	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Zeno Alpha Inc.

Countries where clinical trial is conducted

United States,  Belarus,  Bosnia and Herzegovina,  Czechia,  Hungary,  Lithuania,  Russian Federation,  Serbia,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Phase 1 ESC: Determine a maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) for ZN-c5 as a monotherapy		9 months
Primary	Phase 1 ESC: Determine a maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) for ZN-c5 when administered in combination with palbociclib		9 months
Primary	Phase 1 EXP: Safety and tolerability of ZN-c5 as a monotherapy as measured by number of treatment-emergent adverse events	Measured by the number of treatment-emergent adverse events	9 months
Primary	Phase 2: Determine preliminary anti-tumor efficacy (Clinical Benefit Rate [CBR]) for ZN-c5 as a monotherapy		Through study completion (approximately 2 years)
Primary	Phase 2: Determine preliminary anti-tumor efficacy (CBR) for ZN-c5 when administered in combination with palbociclib		Through study completion (approximately 2 years)
Secondary	Safety and tolerability of ZN-c5 as a monotherapy as measured by number of treatment-emergent adverse events	Measured by the number of treatment-emergent adverse events	Through study completion (approximately 2 years)
Secondary	Safety and tolerability of ZN-c5 in combination with palbociclib as measured by number of treatment emergent adverse events	Measured by the number of treatment-emergent adverse events	Through study completion (approximately 2 years)