EPO906 Therapy in Patients With Advanced Breast Cancer

Breast Neoplasms Clinical Trial

Official title:

An Open-Label Phase IIa Trial Evaluating the Safety and Efficacy of EPO906 as Therapy in Patients With Advanced Breast Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00035126
• Other study ID #: CEPO906A2205
• Status: Completed
• Phase: Phase 2
• First received: May 2, 2002
• Last updated: February 7, 2017
• Start date: January 2002
• Est. completion date: November 2003

Study information

• Verified date: February 2017
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: November 2003
• Est. primary completion date: November 2003
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Breast Neoplasms

Intervention

Drug:
• epothilone b

Locations

Country	Name	City	State
United States	Dartmouth Hitchcock Medical Center	Lebanon	New Hampshire
United States	Cancer Institute of New Jersey (CINJ)	New Brunswick	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tumor response as assessed by radiologic techniques and/or physical examination based on Response Evaluation Criteria in Solid Tumors (RECIST)		Every 8 weeks
Secondary	Time to progression		until disease progression, death or date of last follow-up
Secondary	Overall survival		date of death or last date patient was known to be alive
Secondary	Duration of overall response		every 8 weeks as clinically needed
Secondary	Safety of study drug		weekly for the first 8 weeks, then every other week
Secondary	pharmacokinectics of study drug		every 8 weeks