Status:
COMPLETED
A Study of ZN-c5 and Abemaciclib in Participants With Breast Cancer
Lead Sponsor:
Zeno Alpha Inc.
Conditions:
Breast Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This is a Phase 1b, open-label, multicenter, dose-escalation study to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary efficacy of ZN-c5 administered orally in combination wit...
Eligibility Criteria
Inclusion
- Age ≥ 18 years of age
- Women can be peri- or 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 (FSH) level within the laboratory's reference range for postmenopausal females;
- Documented bilateral oophorectomy;
- 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 adenocarcinoma of the breast
- Estrogen receptor positive disease
- Human Epidermal Growth Factor Receptor 2 negative disease
- Measurable disease per Response Evaluation Criteria in Solid Tumors v1.1
Exclusion
- Prior therapy within the following windows:
- Tamoxifen, aromatase inhibitor, fulvestrant, or other anti-cancer endocrine therapy \< 14 days;
- Any investigational drug therapy \< 28 days or 5 half-lives (whichever is shorter)
- Any prior systemic chemotherapy regardless of the stop date, but the subject must have recovered to eligibility levels from prior toxicity
- Prior treatment with CDK4/6 inhibitors
- Unexplained symptomatic endometrial disorders (including, but not limited to, endometrial hyperplasia, dysfunctional uterine bleeding, or cysts)
Key Trial Info
Start Date :
November 12 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 24 2022
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT04514159
Start Date
November 12 2020
End Date
October 24 2022
Last Update
February 1 2023
Active Locations (5)
Enter a location and click search to find clinical trials sorted by distance.
1
Site 2
Gilbert, Arizona, United States, 85234
2
Site 1
Charleston, South Carolina, United States, 29414
3
Site 6
Grudziądz, Poland, 86-300
4
Site 4
Krakow, Poland, 30-348