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EPO906 Therapy in Patients With Advanced Breast Cancer

This study has suspended participant recruitment.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00035126
First received: May 2, 2002
Last updated: September 23, 2011
Last verified: September 2011
  Purpose

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 Intervention Phase
Breast Neoplasms
Drug: epothilone b
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to progression [ Time Frame: until disease progression, death or date of last follow-up ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: date of death or last date patient was known to be alive ] [ Designated as safety issue: No ]
  • Duration of overall response [ Time Frame: every 8 weeks as clinically needed ] [ Designated as safety issue: No ]
  • Safety of study drug [ Time Frame: weekly for the first 8 weeks, then every other week ] [ Designated as safety issue: Yes ]
  • pharmacokinectics of study drug [ Time Frame: every 8 weeks ] [ Designated as safety issue: No ]

Enrollment: 46
Study Start Date: January 2002
Primary Completion Date: November 2003 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: EPO906 Drug: epothilone b

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00035126

Locations
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
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT00035126     History of Changes
Other Study ID Numbers: CEPO906A2205
Study First Received: May 2, 2002
Last Updated: September 23, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Novartis:
breast
cancer
tumor
tumour
intravenous
epothilone
taxane
anthracycline

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

ClinicalTrials.gov processed this record on November 20, 2014