An Open-label, Randomized, Phase II Study of the Efficacy and Safety of Indisulam (E7070) in Combination With Capecitabine
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|ClinicalTrials.gov Identifier: NCT00165880|
Recruitment Status : Terminated (This study was stopped prematurely due to lack of efficacy.)
First Posted : September 14, 2005
Last Update Posted : July 1, 2014
|Condition or disease||Intervention/treatment||Phase|
|Metastatic Breast Cancer||Drug: E7070||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||62 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||December 2004|
|Actual Study Completion Date :||September 2007|
- Tumor measurements to be done by CT/MRI or photography in accordance with the RECIST criteria and radiography protocol provided. Six month and median overall survival, pain and analgesia score.
- Clinical examination, adverse events, laboratory screens and electrocardiograms. Also, independent radiological review using RECIST criteria.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00165880
|Study Director:||Jantien Wanders||Eisai Limited|