Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ONO-4578 + letrozole + palbociclib | Experimental |
| |
| ONO-4578 + letrozole + abemaciclib | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ONO-4578 | Drug | Specified dose on specified days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events | Through study completion, an average of 4 year | |
| Serious adverse events | Through study completion, an average of 4 year | |
| Dose-limiting toxicity (Tolerability Confirmation part only) | 28 days | |
| Laboratory abnormality profile of Drugs as measured by incidence and severity of clinical laboratory abnormalities | Through study completion, an average of 4 year | |
| Body temperature | Through study completion, an average of 4 year | |
| Pulse rate | Through study completion, an average of 4 year | |
| Systolic/diastolic blood pressure | Through study completion, an average of 4 year | |
| Saturation of Percutaneous Oxygen (SpO2) | Through study completion, an average of 4 year | |
| Weight | Through study completion, an average of 4 year | |
| Eastern Cooperative Oncology Group Performance Status | Through study completion, an average of 4 year | |
| Chest X-ray |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Project Leader | Ono Pharmaceutical Co., Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aichi Cancer Center Hospital | Nagoya | Aichi-ken | Japan | |||
| Nagoya University Hospital |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| letrozole | Drug | Specified dose on specified days |
|
| Palbociclib | Drug | Specified dose on specified days |
|
| abemaciclib | Drug | Specified dose on specified days |
|
| Through study completion, an average of 4 year |
| CT scan | Through study completion, an average of 4 year |
| 12-lead electrocardiography (Heart rate) | Through study completion, an average of 4 year |
| 12-lead electrocardiography (PR interval) | Through study completion, an average of 4 year |
| 12-lead electrocardiography (RR interval) | Through study completion, an average of 4 year |
| 12-lead electrocardiography (QRS width) | Through study completion, an average of 4 year |
| 12-lead electrocardiography (QT interval) | Through study completion, an average of 4 year |
| 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 |
| Best overall response (BOR) | 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 |
| Nagoya |
| Aichi-ken |
| Japan |
| Chiba Cancer Center | Chiba | Chiba | Japan |
| National Cancer Center Hospital East | Kashiwa-shi | Chiba | Japan |
| St. Marianna University Hospital | Kawasaki-shi | Kanagawa | Japan |
| Kanagawa Cancer Center | Yokohama | Kanagawa | Japan |
| University Hospital Kyoto Prefectural University of Medicine | Kyoto | Kyoto | Japan |
| Tohoku University Hospital | Sendai | Miyagi | Japan |
| Osaka International Cancer Institute | Osaka | Osaka | Japan |
| Saitama Cancer Center | Shinden | Saitama | Japan |
| National Cancer Center Hospital | Chuo-ku | Tokyo | Japan |
| The Cancer Institute Hospital Of JFCR | Koto-ku | Tokyo | Japan |
| Tokyo Medical University Hospital | Shinjuku-ku | Tokyo | Japan |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D009362 | Neoplasm Metastasis |
| D012008 | Recurrence |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D020969 | Disease Attributes |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077289 | Letrozole |
| C500026 | palbociclib |
| C000590451 | abemaciclib |
| ID | Term |
|---|---|
| D009570 | Nitriles |
| D009930 | Organic Chemicals |
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided