Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1/PHASE2
181 participants
INTERVENTIONAL
2018-11-30
2022-12-22
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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ZN-c5 monotherapy
Dose escalation cohorts are planned to determine maximum tolerated dose(MTD) or recommended phase 2 dose (RP2D) of ZN-c5 as well as expansion cohorts and a Phase 2 cohort.
ZN-c5
ZN-c5 is a study drug
ZN-c5 + palbociclib combination therapy
Dose escalation cohorts are planned to determine maximum tolerated dose(MTD) or recommended phase 2 dose (RP2D) of ZN-c5 in combination with palbociclib as well as a Phase 2 cohort.
ZN-c5
ZN-c5 is a study drug
Palbociclib
Palbociclib (IBRANCE®) is an approved drug
Interventions
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ZN-c5
ZN-c5 is a study drug
Palbociclib
Palbociclib (IBRANCE®) is an approved drug
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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)
18 Years
ALL
No
Sponsors
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Zeno Alpha Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Zeno Alpha, Inc.
Role: STUDY_DIRECTOR
Zeno Alpha Inc.
Locations
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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
Site 52
Omsk, , Russia
Site 41
Pyatigorsk, , Russia
Site 39
Saint Petersburg, , Russia
Site 42
Yekaterinburg, , Russia
Site 18
Belgrade, , Serbia
Site 19
Belgrade, , Serbia
Site 21
Niš, , Serbia
Site 20
Novi Sad, , Serbia
Site 25
Cherkasy, , Ukraine
Site 27
Kharkiv, , Ukraine
Site 24
Kropyvnytskyi, , Ukraine
Site 26
Kryvyi Rih, , Ukraine
Site 23
Kyiv, , Ukraine
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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ZN-c5-001
Identifier Type: -
Identifier Source: org_study_id
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