Phase 1 Study of E7090 in Subjects With Solid Tumor

• Status: Completed
• Trial end date: 2021-09-03
• Target enrollment: 0
• Participant gender: All

Summary

This is a Phase 1 study of E7090 in subjects with advanced solid tumors. This study will be conducted in 2 parts:

1. Part 1 will be the dose escalation portion of this study to determine the maximum tolerated dose in subjects with solid tumors, and

2. Part 2 will comprise cohort expansions to further characterize the safety and tolerability of E7090 and to assess preliminary efficacy of E7090 in subjects with solid tumors characterized by genetic abnormalities in FGF/FGFR pathway.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eisai Co., Ltd.

Criteria

Inclusion Criteria: Part 1and Part 2

1. Provide written informed consent

2. Male or female subjects age >= 20 years at the time of informed consent

3. Subjects with a histological and/or cytological diagnosis of solid tumor

4. Subjects who failed standard therapies, or for which no appropriate treatment is available.

5. Subjects with Performance Status (PS) score of 0-1 established by Eastern Cooperative Oncology Group (ECOG)

6. Subjects who are expected to survive for 3 months or longer after starting administration of the investigational drug.

Inclusion Criteria: Part 2 only

7. Subjects with tumor expressing genetic abnormality in FGF/FGFR (fibroblast growth factor/ fibroblast growth factor receptor)pathway.

Exclusion criteria

1. Patients with brain metastasis who have clinical symptoms or requiring treatment.

2. Medical history of clinically significant cardiovascular impairment

3. Concomitant systemic infection requiring medical treatment

4. Effusion requiring drainage

5. Known intolerance to the study drug (or any of excipients)

6. Subjects whose toxicity of previous treatment has not recovered to Grade 1 or lower (except for alopecia).

7. Inability to take oral medication, or malabsorption syndrome, or any other uncontrolled gastrointestinal condition (e.g., nausea, diarrhea, or vomiting) that might impair the bioavailability of E7090.

8. Psychiatric disorder (e.g., alcohol or drug dependency) judged to be ineligible for study entry by the investigator or subinvestigator

9. Females who are pregnant or breastfeeding

10. Any subjects who are judged by the principal investigator or the other investigators to be inappropriate as subjects in this clinical study.