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Sponsored by: |
Eisai Limited |
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Information provided by: | Eisai Medical Research Inc. |
ClinicalTrials.gov Identifier: | NCT00869895 |
The purpose of this study is to determine the maximum tolerated dose (MTD) of E7050 given orally in patients with advanced solid tumors.
Condition | Intervention | Phase |
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Cancer |
Drug: E7050 |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study |
Official Title: | A Phase I Dose-Finding Study of E7050 Administered Orally to Patients With Advanced Solid Tumors |
Estimated Enrollment: | 60 |
Study Start Date: | March 2009 |
Estimated Primary Completion Date: | August 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental |
Drug: E7050
Oral dosing starting at 100 mg once daily. After the MTD of once daily dosing has been determined, subsequent cohorts will be treated with a divided dosing schedule either twice or three times daily. The starting dose for this schedule will be an appropriate level below the MTD for once daily dosing.
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Be willing and able to comply with the study protocol, and can give written informed consent.
Additional inclusion criterion for the additional 15 patients recruited to the expanded MTD cohort only:
Exclusion Criteria:
Pregnancy or lactation. Female patients of childbearing potential must have a negative pregnancy test before inclusion into the study, and must agree to use medically acceptable methods of contraception (e.g. abstinence, or a double-barrier method [e.g. condom + spermicide, condom + diaphragm with spermicide], or IUD, or have a vasectomised partner) starting at Screening and throughout the entire study period and for 2 months after the last dose of study drug. Those female patients using hormonal contraceptives must also be using an additional approved method of contraception (as described previously) starting at Cycle 1 Day 1, and continuing throughout the entire study period and for 2 months after the last dose of study drug.
Perimenopausal women must have been amenorrheic for at least 12 months; otherwise a pregnancy test is required.
Male patients must agree to use contraceptive methods (e.g., abstinence, or a double-barrier method [e.g., condom + spermicide, condom + partner diaphragm with spermicide]).
Additional exclusion criterion for the additional 15 patients recruited to the expanded MTD cohort only:
Contact: Eisai Limited | +44 (0)20 8600 1400 |
United Kingdom | |
Christie Hospital | Recruiting |
Manchester, United Kingdom, M20 4BX | |
Royal Marsden Hospital | Recruiting |
Surrey, United Kingdom, SM2 5PT |
Study Director: | Wouter Hanekom | Eisai Limited |
Responsible Party: | Eisai Limited ( Dr. Wouter Hanekom, Study Director ) |
Study ID Numbers: | E7050-E044-101 |
Study First Received: | March 25, 2009 |
Last Updated: | April 20, 2009 |
ClinicalTrials.gov Identifier: | NCT00869895 History of Changes |
Health Authority: | European Union: European Medicines Agency |
Advanced solid tumors |
Signs and Symptoms |