EPO906 Therapy in Patients With Advanced Ovarian, Primary Fallopian, or Primary Peritoneal Cancer - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

May 2, 2002

Last Updated Date

December 9, 2008

Start Date ^†

Current Primary Outcome Measures ^†

Maximum tolerated dose

Original Primary Outcome Measures ^†

Response

Change History

Complete list of historical versions of study NCT00035100 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

Time to progression
Overall survival

Original Secondary Outcome Measures ^†

Time to progression
Overall survival

Descriptive Information

Brief Title ^†

EPO906 Therapy in Patients With Advanced Ovarian, Primary Fallopian, or Primary Peritoneal Cancer

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

Brief Summary

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.

Detailed Description

Study Phase

Phase II

Study Type ^†

Interventional

Study Design ^†

Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study

Condition ^†

Ovarian Neoplasms
Peritoneal Neoplasms
Fallopian Tube Neoplasms

Intervention ^†

Drug: epothilone b

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Completed

Enrollment ^†

Completion Date

Primary Completion Date

Eligibility Criteria ^†

Inclusion Criteria

The following patients may be eligible for the study:

Histologically or cytologically documented evidence of ovarian, primary Fallopian or primary peritoneal cancer with at least one measurable lesion (if previous radiation treatment, the target lesion must have demonstrated progression since the radiation)
Must have a life expectancy of greater than three (3) months
Prior failure to respond following front-line treatment with a taxane and platinum (or a combination therapy) may be eligible.

Exclusion Criteria

The following patients are not eligible for the study:

Patients with radiation therapy or chemotherapy within the last four weeks
Patients who have had any chemotherapy not containing a taxane and platinum for their disease
Patients with borderline ovarian and macropapillary tumors
Patients with unresolved bowel obstruction
Patients with symptomatic CNS metastases or leptomeningeal involvement
Patients with any peripheral neuropathy or unresolved diarrhea greater than Grade 1
Patients with severe cardiac insufficiency
Patients taking Coumadin or other warfarin-containing agents with the exception of low dose Coumadin (1 mg or less) for the maintenance of in-dwelling lines or ports
History of another malignancy within 5 years prior to study entry except curatively treated non-melanoma skin cancer or cervical cancer in situ
Patients with active or suspected acute or chronic uncontrolled infection including abcesses or fistulae
HIV+ patients
Pregnant or lactating females.

Gender

Female

Ages

18 Years to 85 Years

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

United States

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00035100

Responsible Party

External Affairs, Novartis

Secondary IDs ^††

Study Sponsor ^†

Novartis

Collaborators ^††

Investigators ^†

Study Chair:

Novartis

Information Provided By

Novartis

Verification Date

December 2008

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.