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Sponsored by: |
Eisai Limited |
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Information provided by: | Eisai Medical Research Inc. |
ClinicalTrials.gov Identifier: | NCT00326950 |
To investigate primary object (dose limiting toxicity an maximum tolerated dose) and secondary objects (pharmacokinetics, safety, estimated of recommended dose, and anti-tumor effect in evaluable cases) of E7389 in patients with solid tumors by intravenously administering on Days 1 and 8 of a 21 day cycle.
Condition | Intervention | Phase |
---|---|---|
Cancer |
Drug: E7389 |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study |
Official Title: | Phase I Clinical Study of E7389 in Patients With Solid Tumors |
Estimated Enrollment: | 24 |
Study Start Date: | May 2006 |
Estimated Study Completion Date: | March 2008 |
Arms | Assigned Interventions |
---|---|
1: Active Comparator |
Drug: E7389
E7389 intravenously administered on day 1 and 8 of a 21-day cycle.
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2: Active Comparator |
Drug: E7389
E7389 intravenously administered on day 1 and 8 of a 21-day cycle.
|
3: Active Comparator |
Drug: E7389
E7389 intravenously administered on day 1 and 8 of a 21-day cycle.
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4: Active Comparator |
Drug: E7389
E7389 intravenously administered on day 1 and 8 of a 21-day cycle.
|
Ages Eligible for Study: | 20 Years to 74 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion criteria:
(1) Neutrophil count 1,500/mm3 (2) Platelet count 100,000/mm3 (3) Hemoglobin 9.0 g/dL (4) Aspartate aminotransferase [AST] 2.5 times the upper limits of normal in institute, unlessrelated to liver involvement by tumor, in which case
5.0 times ULN (6) Total bilirubin 1.5 times the upper limits of normal in institute (7) Serum creatinine 1.5 times the upper limits of normal in institute (8) SpO2 90%
7) Patients with no adverse drug reactions (excluding alopecia, etc.) that were caused by the prior therapy or could influence the safety evaluation of the study drug.
The withdrawal periods required from the completion of the prior therapy to the start of the study drug therapy are as follows:
8) Patients who give written informed consent
9) Patients with an expected survival of longer than 3 months from the start of the study drug therapy
Exclusion criteria:
Women who are pregnant or breastfeeding, or premenopausal women of childbearing potential.
Post-menopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential. Premenopausal women of childbearing potential with either a positive pregnancy test at screening or no pregnancy test, or have not agreed to use adequate measures of contraception.
Responsible Party: | Eisai Company Limited ( Tomio Nakamura, Study Director ) |
Study ID Numbers: | E7389-J081-105 |
Study First Received: | May 16, 2006 |
Last Updated: | December 5, 2007 |
ClinicalTrials.gov Identifier: | NCT00326950 History of Changes |
Health Authority: | Japan: Ministry of Health, Labor and Welfare |
Cancer Tumors Phase I E7389 |