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| Sponsor: | Novartis Pharmaceuticals |
|---|---|
| Information provided by: | Novartis |
| ClinicalTrials.gov Identifier: | NCT00035100 |
Purpose
This study will examine whether the new 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 ovarian, fallopian, or peritoneal cancers. Recruitment in the United States is complete but the study is still enrolling in other countries.
| Condition | Intervention | Phase |
|---|---|---|
|
Ovarian Neoplasms Peritoneal Neoplasms Fallopian Tube 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 Ovarian, Primary Fallopian, or Primary Peritoneal Cancer |
| Enrollment: | 112 |
| Study Start Date: | September 2001 |
| Primary Completion Date: | August 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: EPO906 |
Drug: epothilone b
Other Name: EPO906
|
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 the study:
Exclusion Criteria:
The following patients are not eligible for the study:
Contacts and Locations| United States, California | |
| California Pacific Medical Center | |
| San Francisco, California, United States, 94116 | |
| United States, Connecticut | |
| St. Francis Hospital | |
| Hartford, Connecticut, United States, 06105 | |
| United States, Maryland | |
| The Sidney Kimmel Comprehensive Cancer Center | |
| Baltimore, Maryland, United States, 21287 | |
| United States, Nevada | |
| Women's Cancer Center of Nevada | |
| Las Vegas, Nevada, United States, 89109 | |
| United States, Rhode Island | |
| Women and Infants Hospital | |
| Providence, Rhode Island, United States, 02905 | |
| United States, Tennessee | |
| Sarah Cannon Cancer Center | |
| Nashville, Tennessee, United States, 37203 | |
| United States, Utah | |
| Huntsman Cancer Institute, University of Utah | |
| Salt Lake City, Utah, United States, 84112 | |
| Study Director: | Novartis Pharmaceuticals | Novartis Pharmaceuticals |
More Information
| Responsible Party: | External Affairs, Novartis Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT00035100 History of Changes |
| Other Study ID Numbers: | CEPO906A2203 |
| Study First Received: | May 2, 2002 |
| Last Updated: | March 24, 2011 |
| Health Authority: | United States: Food and Drug Administration |
|
ovarian ovary peritoneal cancer fallopian cancer cancer tumor |
tumour neoplasm carcinoma intravenous epothilone |
|
Neoplasms Fallopian Tube Neoplasms Ovarian Neoplasms Peritoneal Neoplasms Genital Neoplasms, Female Urogenital Neoplasms Neoplasms by Site Fallopian Tube Diseases Adnexal Diseases Genital Diseases, Female Endocrine Gland Neoplasms Ovarian Diseases Endocrine System Diseases Gonadal Disorders |
Abdominal Neoplasms Digestive System Neoplasms Digestive System Diseases Peritoneal Diseases Epothilone B Epothilones Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents Therapeutic Uses |