EPO906 Therapy in Patients With Advanced Breast Cancer

NCT ID: NCT00035126

Last Updated: 2017-02-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 46 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-01-31
• Study Completion Date: 2003-11-30

Brief Summary

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.

Conditions

Breast Neoplasms

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

EPO906

Group Type: EXPERIMENTAL

epothilone b

Intervention Type: DRUG

Interventions

epothilone b

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

The following patients may be eligible for this study:

• Histologically or cytologically documented evidence of disease with at least one measurable lesion;
• Life expectancy of greater than three (3) months;
• Patients who have had only one prior therapy for metastatic disease;
• Patients who have received prior treatment with hormonal agents or who have had prior treatment regimens of radiotherapy in addition to one or no previous chemotherapy regimens are eligible;
• Patients who have had no prior therapy for metastatic disease, but who have received a taxane and an anthracycline (single or combination therapy) as adjuvant treatment, are eligible. For patients who have had previous radiation therapy to the target lesion(s), the lesion(s) must since have demonstrated progression.

Exclusion Criteria

The following patients are not eligible for this study:

• Bone-only disease;
• Symptomatic pleural effusions;
• Symptomatic CNS metastases or leptomeningeal involvement;
• Any peripheral neuropathy or unresolved diarrhea greater than Grade 1;
• 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 ckin cancer or cervical cancer in situ;
• Active or suspected acute or chronic uncontrolled infection including abcesses or fistulae;
• HIV+ patients;
• Pregnant or lactating females;
• Patients who have had radiation, chemotherapy, or hormonal therapy within the last four (4) weeks excluding palliative radiotherapy to isolated peripheral bone metastases not being used as markers for efficacy;
• Patients taking Herceptin less than three (3) weeks prior to study start.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Novartis Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

Dartmouth Hitchcock Medical Center

Lebanon, New Hampshire, United States

Cancer Institute of New Jersey (CINJ)

New Brunswick, New Jersey, United States

Countries

United States

Other Identifiers

CEPO906A2205

Identifier Type: -

Identifier Source: org_study_id