At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 181 enrolled
Drug / intervention
ZN-c5 +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 2 clinical trial evaluating ZN-c5 and Palbociclib for Breast Cancer. Completed, enrolled 181 participants across 38 sites in 9 countries.
Detailed 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®).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBreast Cancer
CountriesBelarus, Bosnia and Herzegovina, Czechia, Hungary, Lithuania, Russia, Serbia, Ukraine, United States
Collaborators--
Timeline
Phase 2CompletedFinished
20192020202120222023202420252026
First PostedJun 2018
Enrollment StartNov 2018
Primary CompletionApr 2022
Study CompletionDec 2022
TodayJul 2026
First PostedJun 18, 2018
Enrollment StartNov 30, 2018
Primary CompletionApr 26, 2022
Study CompletionDec 22, 2022
TodayJul 2, 2026
Enrollment to primary: 3.4 yearsPosted 8.0 years ago
Interventions
ZN-c5drug
ZN-c5 is a study drug
Palbociclibdrug
Palbociclib (IBRANCE®) is an approved drug