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| Sponsor: | Novartis Pharmaceuticals |
|---|---|
| Information provided by (Responsible Party): | Novartis ( Novartis Pharmaceuticals ) |
| ClinicalTrials.gov Identifier: | NCT00035126 |
Purpose
This study will examine whether the investigational drug EPO906, given by intravenous infusion (IV directly into the vein), is effective in shrinking tumors and preventing the growth of cells that cause breast cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Breast Neoplasms |
Drug: epothilone b |
Phase II |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | An Open-Label Phase IIa Trial Evaluating the Safety and Efficacy of EPO906 as Therapy in Patients With Advanced Breast Cancer |
| Enrollment: | 46 |
| Study Start Date: | January 2002 |
| Primary Completion Date: | November 2003 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: EPO906 | Drug: epothilone b |
Eligibility| Ages Eligible for Study: | 18 Years to 85 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
The following patients may be eligible for this study:
Exclusion Criteria:
The following patients are not eligible for this study:
Contacts and Locations| United States, New Hampshire | |
| Dartmouth Hitchcock Medical Center | |
| Lebanon, New Hampshire, United States, 03756 | |
| United States, New Jersey | |
| Cancer Institute of New Jersey (CINJ) | |
| New Brunswick, New Jersey, United States, 08901 | |
| Study Director: | Novartis Pharmaceuticals | Novartis Pharmaceuticals |
More Information
| Responsible Party: | Novartis ( Novartis Pharmaceuticals ) |
| ClinicalTrials.gov Identifier: | NCT00035126 History of Changes |
| Other Study ID Numbers: | CEPO906A2205 |
| Study First Received: | May 2, 2002 |
| Last Updated: | September 23, 2011 |
| Health Authority: | United States: Food and Drug Administration |
|
breast cancer tumor tumour |
intravenous epothilone taxane anthracycline |
|
Breast Neoplasms Neoplasms Neoplasms by Site Breast Diseases Skin Diseases Epothilone B Epothilones |
Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents Therapeutic Uses |