ONO-4578-06:Phase I Study of ONO-4578 and Letrozole Plus CDK4 /6 Inhibitors in Breast Cancer

Phase 1

Active, not recruiting

• Conditions: Metastatic Breast Cancer; Hormone Receptor-positive Breast Cancer; HER2-negative Breast Cancer; Recurrent Breast Cancer
• Interventions: Drug: ONO-4578; Drug: letrozole; Drug: abemaciclib; Drug: Palbociclib

• Registration Number: NCT06570031
• Lead Sponsor: Ono Pharmaceutical Co. Ltd

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 ...

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2021-11-09
• Study First Submitted: 2024-07-31
• Status Verified: 2024-08
• Study First Submitted QC: 2024-08-21
• Last Update Submitted: 2024-08-21
• Study First Posted: 2024-08-26
• Last Update Posted: 2024-08-26
• Primary Completion: 2025-07-31
• Study Completion: 2025-07-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 46

Inclusion Criteria

1. Patients with postmenopausal metastatic or recurrent breast cancer
2. Patients with ECOG Performance Status 0 to 1
3. ER-positive, PgR-positive and HER2-negative patients

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Exclusion Criteria

1. Patients are unable to swallow oral medications
2. Patients with severe complication

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ONO-4578 + letrozole + palbociclib	letrozole	-
ONO-4578 + letrozole + abemaciclib	ONO-4578	-
ONO-4578 + letrozole + palbociclib	ONO-4578	-
ONO-4578 + letrozole + abemaciclib	abemaciclib	-
ONO-4578 + letrozole + abemaciclib	letrozole	-
ONO-4578 + letrozole + palbociclib	Palbociclib	-

Primary Outcome Measures

Name	Time	Method
Dose-limiting toxicity (Tolerability Confirmation part only)	28 days
Serious adverse events	Through study completion, an average of 4 year
Pulse rate	Through study completion, an average of 4 year
Adverse events	Through study completion, an average of 4 year
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
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	Through study completion, an average of 4 year
CT scan	Through study completion, an average of 4 year
12-lead electrocardiography (RR interval)	Through study completion, an average of 4 year
12-lead electrocardiography (PR interval)	Through study completion, an average of 4 year
12-lead electrocardiography (Heart rate)	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

Secondary Outcome Measures

Name	Time	Method
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
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

Trial Locations

Locations (13)

Saitama Cancer Center; 🇯🇵 Ina, Saitama, Japan

Tokyo Medical University Hospital; 🇯🇵 Shinjuku-ku, Tokyo, Japan

National Cancer Center Hospital East; 🇯🇵 Kashiwa-shi, Chiba, Japan

Kanagawa Cancer Center; 🇯🇵 Yokohama-shi, Kanagawa, Japan

University Hospital Kyoto Prefectural University of Medicine; 🇯🇵 Kyoto-shi, Kyoto, Japan

Aichi Cancer Center Hospital; 🇯🇵 Nagoya-shi, Aichi, Japan

Osaka International Cancer Institute; 🇯🇵 Osaka-shi, Osaka, Japan

Tohoku University Hospital; 🇯🇵 Sendai-shi, Miyagi, Japan

National Cancer Center Hospital; 🇯🇵 Chuo-ku, Tokyo, Japan

Nagoya University Hospital; 🇯🇵 Nagoya-shi, Aichi, Japan

Chiba Cancer Center; 🇯🇵 Chiba-shi, Chiba, Japan

St. Marianna University Hospital; 🇯🇵 Kawasaki-shi, Kanagawa, Japan

The Cancer Institute Hospital Of JFCR; 🇯🇵 Koto-ku, Tokyo, Japan