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| Sponsor: | Eisai Limited |
|---|---|
| Information provided by: | Eisai Inc. |
| ClinicalTrials.gov Identifier: | NCT00165880 |
Purpose
The overall purpose of this study is to compare the efficacy, safety and tolerability of indisulam in combination with capecitabine (IC) versus capecitabine (C) monotherapy in patients with metastatic breast cancer who have previously been treated with an anthracycline and a taxane.
| Condition | Intervention | Phase |
|---|---|---|
|
Metastatic Breast Cancer |
Drug: E7070 |
Phase II |
| Study Type: | Interventional |
| Study Design: | Diagnostic, Randomized, Open Label, Active Control, Single Group Assignment, Efficacy Study |
| Official Title: | An Open-Label, Randomized, Phase II Study of the Efficacy and Safety of Indisulam (E7070) in Combination With Capecitabine Versus Capecitabine Monotherapy for the Treatment of Metastatic Breast Cancer Patients Following Prior Anthracycline and Taxane Therapy |
| Enrollment: | 62 |
| Study Start Date: | December 2004 |
| Study Completion Date: | September 2007 |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| 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:
Contacts and Locations| Germany | |
| Charite Universitatsmedizin Berlin | |
| Berlin, Germany, D-12200 | |
| Stadt Kliniken Frankfurt-Hochst | |
| Frankfurt, Germany, D-65929 | |
| Medizinische Klinik und Poliklinik | |
| Mainz, Germany, D-55101 | |
| Zentrum fur Innere Medizin Hamatologie / Onkologie | |
| Stuttgart, Germany, D-70376 | |
| IORC Gmbh | |
| Hamburg, Germany, D-22081 | |
| Italy | |
| Ospedale Morgagni-Pierantoni | |
| Forli, Italy, I-47100 | |
| Ospedale San Filippo Neri | |
| Roma, Italy, I-00135 | |
| Palilinico Universitano | |
| Palermo, Italy, I-90127 | |
| A.O. Arciospedate S. Maria Nuova | |
| Reggio Emilia, Italy, I-42100 | |
| Ospedale S. Maria Annunzialata | |
| Firenze, Italy, I-50011 | |
| Ospedali Ruiniti | |
| Bergamo, Italy, I-24128 | |
| Azienda Ospedaliera Pisana | |
| Pisa, Italy, I-56126 | |
| IST Istituto nazionale per la Ricerca | |
| Genova, Italy, I-16132 | |
| Russian Federation | |
| Semashko Central Clinical Hospital | |
| Moscow, Russian Federation, 129128 | |
| Hertzen Research Institute of Oncology | |
| Moscow, Russian Federation, 125284 | |
| Rostov Oncology Research Institute | |
| Rostov-on-Don, Russian Federation, 344037 | |
| Arkhangelsk Regional Clinical Oncology Center | |
| Arkhangelsk, Russian Federation, 163045 | |
| Petrov Research Institute of Oncology | |
| St. Petersburg, Russian Federation, 197758 | |
| Chelyabinsk Regional Oncology Center | |
| Chelyabinsk, Russian Federation, 454087 | |
| Krasnodar City Oncology Center | |
| Krasnodar, Russian Federation, 350040 | |
| Leningrad Regional Oncology Center | |
| Kuzmolovo, Russian Federation, 188663 | |
| Spain | |
| Hospital Universiatio de Guadalajara | |
| Guadalajara, Spain, I-19002 | |
| Centro Oncologico Regional de Galicia | |
| La Coruna, Spain, E-15009 | |
| Hospital Unicersaitario de La Princesa | |
| Madrid, Spain, E-28006 | |
| Hospital Clinico U. Virgen de la Victoria | |
| Malaga, Spain, E-29010 | |
| Hospital Clinico Universitario Lozano Blesa | |
| Zaragoza, Spain, I-19002 | |
| Hospital Clinico Universitario Lozano Blesa | |
| Zaragoza, Spain, E-50009 | |
| Centro Oncologico Anderson Internacional | |
| Madrid, Spain, E-28033 | |
| United Kingdom | |
| South West Wales Cancer Institute | |
| Swansea, United Kingdom, SA2 8QA | |
| Christie Hospital NHS Trust | |
| Manchester, United Kingdom, M20 4GJ | |
| Cookridge Hospital | |
| Leeds, United Kingdom, LS16 6QB | |
| Mount Vernon Cancer Centre | |
| Northwood, United Kingdom, HA1 2RN | |
| St Bartholomew's Hospital | |
| London, United Kingdom, EC1A 7BE | |
| Study Director: | Jantien Wanders | Eisai Limited |
More Information
| Study ID Numbers: | E7070-E044-213 |
| Study First Received: | September 13, 2005 |
| Last Updated: | March 4, 2008 |
| ClinicalTrials.gov Identifier: | NCT00165880 History of Changes |
| Health Authority: | Russia: Pharmacological Committee, Ministry of Health; United Kingdom: Medicines and Healthcare Products Regulatory Agency; Germany: Federal Institute for Drugs and Medical Devices; Spain: Spanish Agency of Medicines; Italy: Servizio Sanitario Regionale Emilia-Romagna Azienda Unita Sanitaria Locale di Forli (Emilio Romagna Regional Healthcare Service Forli) |
|
Antimetabolites Capecitabine Neoplasms Antimetabolites, Antineoplastic Neoplasms by Site Molecular Mechanisms of Pharmacological Action |
Skin Diseases Antineoplastic Agents Therapeutic Uses Breast Neoplasms Pharmacologic Actions Breast Diseases |