NCT00035126

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
46

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jan 2002

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2002

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

May 2, 2002

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 3, 2002

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2003

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2003

Completed
Last Updated

February 8, 2017

Status Verified

February 1, 2017

Enrollment Period

1.8 years

First QC Date

May 2, 2002

Last Update Submit

February 7, 2017

Conditions

Breast Neoplasms

Keywords

breastcancertumortumourintravenousepothilonetaxaneanthracycline

Outcome Measures

Primary Outcomes (1)

  • Tumor response as assessed by radiologic techniques and/or physical examination based on Response Evaluation Criteria in Solid Tumors (RECIST)

    Every 8 weeks

Secondary Outcomes (5)

  • 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

Study Arms (1)

EPO906

EXPERIMENTAL
Drug: epothilone b

Interventions

epothilone bDRUG
EPO906

Eligibility Criteria

Age18 Years - 85 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Dartmouth Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

Location

Cancer Institute of New Jersey (CINJ)

New Brunswick, New Jersey, 08901, United States

Location

MeSH Terms

Conditions

Breast NeoplasmsNeoplasms

Interventions

epothilone B

Condition Hierarchy (Ancestors)

Neoplasms by SiteBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Novartis Pharmaceuticals

    Novartis Pharmaceuticals

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 2, 2002

First Posted

May 3, 2002

Study Start

January 1, 2002

Primary Completion

November 1, 2003

Study Completion

November 1, 2003

Last Updated

February 8, 2017

Record last verified: 2017-02

Locations

US(2)