A Study of E7050 Administered Orally to Patients With Advanced Solid Tumors
NCT ID: NCT00921869
Last Updated: 2017-12-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
16 participants
INTERVENTIONAL
2009-10-31
2011-06-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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1
E7050
The starting dose of E7050 will be 50 mg given orally, twice-daily, in patients with advanced tumors that have progressed following effective therapy.
Interventions
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E7050
The starting dose of E7050 will be 50 mg given orally, twice-daily, in patients with advanced tumors that have progressed following effective therapy.
Eligibility Criteria
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Inclusion Criteria
2. Subjects who have progressed after treatment with approved therapies or for whom there are no standard effective therapies available.
3. Subjects with adequate organ function.
4. Patients who have no carryover of effect from prior therapy or no adverse drug reactions (excluding alopecia) that may affect the safety evaluation of the investigational drug.
5. Subjects with Performance Status (PS) 0-1 established by Eastern Cooperative Oncology Group (ECOG).
Exclusion Criteria
2. Subjects with the serious complications or disease history.
3. Subjects who cannot take oral medication.
4. Subjects who need continuous use of drugs or foods that strongly inhibit or induce CYP3A4/5 or CYP2D6 during the study period.
5. Female subjects who are pregnant or breast-feeding.
20 Years
74 Years
ALL
No
Sponsors
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Eisai Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Takashi Sawada
Role: STUDY_DIRECTOR
Oncology Clinical Development Section. JAC PCU. Eisai Co., Ltd.
Locations
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Kashiwa-shi, Chiba, Japan
Countries
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Other Identifiers
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E7050-J081-102
Identifier Type: -
Identifier Source: org_study_id