Phase 1 Study of E7090 in Subjects With Solid Tumor
Study Details
Study Description
Brief Summary
This is a Phase 1 study of E7090 in subjects with advanced solid tumors. This study will be conducted in 2 parts:
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Part 1 will be the dose escalation portion of this study to determine the maximum tolerated dose in subjects with solid tumors, and
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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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 1 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: E7090 Arm 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. |
Drug: E7090
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Outcome Measures
Primary Outcome Measures
- Safety and tolerability of E7090 as a measure of Adverse Events/ Serious Adverse Events [Upto 30 days after last administration of drug]
Secondary Outcome Measures
- Best Overall Response (BOR) in targeted population [From screening until the date of discontinuation, assessed up to 100 months.]
Tumor assessment (target lesion, non-target lesion, and presence or absence of new lesion) will be performed based on RECIST v1.1 (Response Evaluation Criteria In Solid Tumors). Tumor marker will also be measured. FDG-PET CT (fluorodeoxyglucose- Positron emission tomography computed tomography) will also be evaluated. Best overall response are complete response (CR), partial response (PR), stable disease (SD), progression of disease (PD), and not evaluable (NE), where SD have to be achieved at >= 7 weeks after first dose.
- Objective Response Rate (ORR) [From screening until the date of discontinuation, assessed up to 100 months.]
ORR is defined as a proportion of subjects with BOR of CR or PR.
- Disease Control Rate (DCR) [From screening until the date of discontinuation, assessed up to 100 months.]
DCR is defined as the proportion of subjects who with BOR of CR, PR or SD.
- Progression- Free Survival (PFS) [From the date of first dose until the first documented date of event (disease progression or death from any cause), assessed up to 100 months.]
PFS is defined as the time from the date of first dose to the first documented date of event (disease progression or death from any cause, whichever occurs first).
- Overall Survival (OS) [From the date of first dose until the date of death from any cause, assessed up to 100 months.]
OS is defined as the time from the date of first dose to the date of death from any cause.
- Maximum tolerated Dose (MTD) of E7090 (part 1) and Recommended Dose (RD) for future studies [On day 35]
- Plasma Cmax (maximum concentration) of E7090 [On day 36]
- Plasma tmax (Time of maximum concentration) of E7090 [On day 36]
- Plasma AUC (Area under the concentration vs time curve) of E7090 [On day 36]
- Pharmacokinetics (PK) of Urine (renal clearance) [On day 36]
Eligibility Criteria
Criteria
Inclusion Criteria: Part 1and Part 2
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Provide written informed consent
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Male or female subjects age >= 20 years at the time of informed consent
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Subjects with a histological and/or cytological diagnosis of solid tumor
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Subjects who failed standard therapies, or for which no appropriate treatment is available.
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Subjects with Performance Status (PS) score of 0-1 established by Eastern Cooperative Oncology Group (ECOG)
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Subjects who are expected to survive for 3 months or longer after starting administration of the investigational drug.
Inclusion Criteria: Part 2 only
- Subjects with tumor expressing genetic abnormality in FGF/FGFR (fibroblast growth factor/ fibroblast growth factor receptor)pathway.
Exclusion criteria
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Patients with brain metastasis who have clinical symptoms or requiring treatment.
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Medical history of clinically significant cardiovascular impairment
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Concomitant systemic infection requiring medical treatment
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Effusion requiring drainage
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Known intolerance to the study drug (or any of excipients)
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Subjects whose toxicity of previous treatment has not recovered to Grade 1 or lower (except for alopecia).
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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.
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Psychiatric disorder (e.g., alcohol or drug dependency) judged to be ineligible for study entry by the investigator or subinvestigator
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Females who are pregnant or breastfeeding
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Any subjects who are judged by the principal investigator or the other investigators to be inappropriate as subjects in this clinical study.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Eisai Trial Site #1 | Nagoya | Aichi | Japan | |
| 2 | Eisai Trial Site #1 | Kashiwa | Chiba | Japan | |
| 3 | Eisai Trial Site #1 | Matsuyama | Ehime | Japan | |
| 4 | Eisai Trial Site #1 | Sapporo | Hokkaido | Japan | |
| 5 | Eisai Trial Site #1 | Amagasaki | Hyogo | Japan | |
| 6 | Eisai Trial Site #1 | Tsukuba | Ibaraki | Japan | |
| 7 | Eisai Trial Site #1 | Kawasaki | Kanagawa | Japan | |
| 8 | Eisai Trial Site #1 | Yokohama | Kanagawa | Japan | |
| 9 | Eisai Trial Site #1 | Chuo-ku | Niigata | Japan | |
| 10 | Eisai Trial Site #1 | Kitaadachi | Saitama | Japan | |
| 11 | Eisai Trial Site #1 | Chuo-Ku | Tokyo | Japan | |
| 12 | Eisai Trial Site #1 | Koto-ku | Tokyo | Japan | |
| 13 | Eisai Trial Site #1 | Chiba | Japan | ||
| 14 | Eisai Trial Site #1 | Fukuoka | Japan | ||
| 15 | Eisai Trial Site #1 | Kyoto | Japan | ||
| 16 | Eisai Trial Site #1 | Osaka | Japan | ||
| 17 | Eisai Trial Site #2 | Osaka | Japan | ||
| 18 | Eisai Trial Site #3 | Osaka | Japan |
Sponsors and Collaborators
- Eisai Co., Ltd.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- E7090-J081-101