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Sponsored by: |
Eisai Limited |
Information provided by: | Eisai Medical Research Inc. |
ClinicalTrials.gov Identifier: | NCT00165867 |
The overall purpose of this study is to determine the efficacy, safety and tolerability of indisulam in combination with irinotecan as a treatment for patients with metastatic colorectalcancer previously treated with 5-fluorouracil/leucovorin and oxaliplatin (FOLFOX).
Condition | Intervention | Phase |
Colorectal Cancer |
Drug: E7070 |
Phase II |
MedlinePlus related topics: | Cancer Colorectal Cancer |
Drug Information available for: | Leucovorin Calcium Citrovorum factor Folinic acid calcium salt pentahydrate Leucovorin Irinotecan Irinotecan hydrochloride Fluorouracil Oxaliplatin |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Efficacy Study |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion criteria:
Exclusion criteria:
Patients with the following characteristics will not be included in the study:
Any of the following laboratory parameters:
France | |||||
Centre Antoine Lacassagne | |||||
Nice, France, F-06189 | |||||
Hôpitaux Civils de Colmar | |||||
Colmar, France, F- 68024 | |||||
CRLC Val d'Aurelle | |||||
Montpellier, France, F-34298 | |||||
United Kingdom | |||||
Beatson Oncology Centre | |||||
Glasgow, United Kingdom, G11 6NT | |||||
Aberdeen Royal Infirmary | |||||
Aberdeen, United Kingdom, AB25 2ZN | |||||
Leicester Royal Infirmary | |||||
Leicester, United Kingdom, LE1 5WW | |||||
Cookridge Hospital | |||||
Leeds, United Kingdom, LS16 6QB |
Eisai Limited |
Study Director: | Jantien Wanders | Eisai Limited |
Study ID Numbers: | E7070-E044-214 |
First Received: | September 13, 2005 |
Last Updated: | October 6, 2006 |
ClinicalTrials.gov Identifier: | NCT00165867 |
Health Authority: | United Kingdom: Medicines and Healthcare Products Regulatory Agency; France: Agence Francaise de Securite Sanitaire des Produits de Sante (AFSSAPS) |
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