EPO906 Therapy in Patients With Advanced Breast Cancer

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

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.

Study Overview

• Status: Completed
• Conditions: Breast Neoplasms
• Intervention / Treatment: Drug: epothilone b

• Study Type: Interventional
• Enrollment (Actual): 46
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • New Hampshire
    • Lebanon, New Hampshire, United States, 03756
      • Dartmouth Hitchcock Medical Center
  • New Jersey
    • New Brunswick, New Jersey, United States, 08901
      • Cancer Institute of New Jersey (CINJ)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: EPO906	Drug: epothilone b

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Tumor response as assessed by radiologic techniques and/or physical examination based on Response Evaluation Criteria in Solid Tumors (RECIST)	Every 8 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Time to progression	until disease progression, death or date of last follow-up
Overall survival	date of death or last date patient was known to be alive
Duration of overall response	every 8 weeks as clinically needed
Safety of study drug	weekly for the first 8 weeks, then every other week
pharmacokinectics of study drug	every 8 weeks

Collaborators and Investigators

• Sponsor: Novartis Pharmaceuticals

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2002
• Primary Completion (Actual): November 1, 2003
• Study Completion (Actual): November 1, 2003

Study Registration Dates

• First Submitted: May 2, 2002
• First Submitted That Met QC Criteria: May 2, 2002
• First Posted (Estimate): May 3, 2002

Study Record Updates

• Last Update Posted (Estimate): February 8, 2017
• Last Update Submitted That Met QC Criteria: February 7, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Keywords: cancer; tumour; breast; taxane; intravenous; tumor; epothilone; anthracycline
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Epothilones; Epothilone B
• Other Study ID Numbers: CEPO906A2205