EPO906 Therapy in Patients With Advanced Breast Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00035126
Recruitment Status : Completed
First Posted : May 3, 2002
Last Update Posted : February 8, 2017
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

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.

Condition or disease Intervention/treatment Phase
Breast Neoplasms Drug: epothilone b Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 46 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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 Breast Cancer
Actual Study Start Date : January 2002
Actual Primary Completion Date : November 2003
Actual Study Completion Date : November 2003

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
U.S. FDA Resources

Arm Intervention/treatment
Experimental: EPO906 Drug: epothilone b

Primary Outcome Measures :
  1. Tumor response as assessed by radiologic techniques and/or physical examination based on Response Evaluation Criteria in Solid Tumors (RECIST) [ Time Frame: Every 8 weeks ]

Secondary Outcome Measures :
  1. Time to progression [ Time Frame: until disease progression, death or date of last follow-up ]
  2. Overall survival [ Time Frame: date of death or last date patient was known to be alive ]
  3. Duration of overall response [ Time Frame: every 8 weeks as clinically needed ]
  4. Safety of study drug [ Time Frame: weekly for the first 8 weeks, then every other week ]
  5. pharmacokinectics of study drug [ Time Frame: every 8 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00035126

United States, New Hampshire
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756
United States, New Jersey
Cancer Institute of New Jersey (CINJ)
New Brunswick, New Jersey, United States, 08901
Sponsors and Collaborators
Novartis Pharmaceuticals
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals

Responsible Party: Novartis Pharmaceuticals Identifier: NCT00035126     History of Changes
Other Study ID Numbers: CEPO906A2205
First Posted: May 3, 2002    Key Record Dates
Last Update Posted: February 8, 2017
Last Verified: February 2017

Keywords provided by Novartis ( Novartis Pharmaceuticals ):

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Epothilone B
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents