Phase 1 Study of E7090 in Subjects With Solid Tumor

Eisai

Status and phase: Completed; Phase 1

Conditions: Tumors

Treatments: Drug: E7090

Study type: Interventional

Funder types: Industry

Identifiers

NCT02275910

E7090-J081-101

Details and patient eligibility

About

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.

Enrollment: 40 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

E7090 Arm

Experimental group

Description:

Oral, starting dose 1 mg once a day, dose escalation in part 1. Cycle 0 is for 7 days. For Cycle 1 and onward, each cycle is 28 days long. The Cycle 0 is set up for PK analysis of a single dose of E7090. In the following Cycle 1, subjects will be administered E7090 QD, and the PK and safety will be assessed for 28 days. One or two doses may be selected from part 1 for Part 2. E7090 will be administered continuously once a daily. Subjects can continue treatment unless they meet discontinuation criteria.

Treatment:

Drug: E7090