ONO-4578-06: Phase I , Open-label, Non-blind, First-line Endocrine Therapy With ONO-4578 and Standard Treatment Letrozole and CDK4/6 Inhibitors (Palbociclib or Abemaciclib) in Patients With Metastatic or Recurrent Postmenopausal Hormone Receptor-positive HER2-negative Breast Cancer
Overview
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Ono Pharmaceutical Co. Ltd
- Enrollment
- 46
- Locations
- 13
- Primary Endpoint
- Dose-limiting toxicity (Tolerability Confirmation part only)
Overview
Brief Summary
This is a multicenter, open-label, non-controlled, phase I study to investigate the tolerability and safety of ONO-4578 used in combination with standard-of-care letrozole and a CDK4/6 inhibitor (palbociclib or Abemaciclib) as first-line endocrine therapy in postmenopausal patients with metastatic or recurrent hormone receptor-positive, HER2-negative breast cancer.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 20 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients with postmenopausal metastatic or recurrent breast cancer
- •Patients with ECOG Performance Status 0 to 1
- •ER-positive, PgR-positive and HER2-negative patients
Exclusion Criteria
- •Patients are unable to swallow oral medications
- •Patients with severe complication
Arms & Interventions
ONO-4578 + letrozole + palbociclib
Intervention: ONO-4578 (Drug)
ONO-4578 + letrozole + palbociclib
Intervention: letrozole (Drug)
ONO-4578 + letrozole + palbociclib
Intervention: Palbociclib (Drug)
ONO-4578 + letrozole + abemaciclib
Intervention: ONO-4578 (Drug)
ONO-4578 + letrozole + abemaciclib
Intervention: letrozole (Drug)
ONO-4578 + letrozole + abemaciclib
Intervention: abemaciclib (Drug)
Outcomes
Primary Outcomes
Dose-limiting toxicity (Tolerability Confirmation part only)
Time Frame: 28 days
Systolic/diastolic blood pressure
Time Frame: Through study completion, an average of 4 year
Saturation of Percutaneous Oxygen (SpO2)
Time Frame: Through study completion, an average of 4 year
Serious adverse events
Time Frame: Through study completion, an average of 4 year
Pulse rate
Time Frame: Through study completion, an average of 4 year
Weight
Time Frame: Through study completion, an average of 4 year
Adverse events
Time Frame: Through study completion, an average of 4 year
Laboratory abnormality profile of Drugs as measured by incidence and severity of clinical laboratory abnormalities
Time Frame: Through study completion, an average of 4 year
Body temperature
Time Frame: Through study completion, an average of 4 year
Eastern Cooperative Oncology Group Performance Status
Time Frame: Through study completion, an average of 4 year
Chest X-ray
Time Frame: Through study completion, an average of 4 year
CT scan
Time Frame: Through study completion, an average of 4 year
12-lead electrocardiography (RR interval)
Time Frame: Through study completion, an average of 4 year
12-lead electrocardiography (PR interval)
Time Frame: Through study completion, an average of 4 year
12-lead electrocardiography (Heart rate)
Time Frame: Through study completion, an average of 4 year
12-lead electrocardiography (QRS width)
Time Frame: Through study completion, an average of 4 year
12-lead electrocardiography (QT interval)
Time Frame: Through study completion, an average of 4 year
Secondary Outcomes
- Best overall response (BOR)(Through study completion, an average of 4 year)
- Overall response rate (ORR)(Through study completion, an average of 4 year)
- Disease control rate (DCR)(Through study completion, an average of 4 year)
- Clinical benefit rate (CBR)(Through study completion, an average of 4 year)
- Overall survival (OS)(Through study completion, an average of 4 year)
- Progression-free survival (PFS)(Through study completion, an average of 4 year)
- Duration of response (DOR)(Through study completion, an average of 4 year)
- Time to response (TTR)(Through study completion, an average of 4 year)
- Percent change in the sum of diameters of target lesions(Through study completion, an average of 4 year)
- Maximum percent change in the sum of diameters of target lesions(Through study completion, an average of 4 year)
- Changes in tumor markers(Through study completion, an average of 4 year)
- Plasma ONO-4578 concentration(Through study completion, an average of 4 year)