NCT00098397

Brief Summary

This phase II trial is studying how well FR901228 works in treating patients with metastatic breast cancer. Drugs used in chemotherapy, such as FR901228, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. FR901228 may also stop the growth of tumor cells by blocking some of the enzymes needed for cell growth

Trial Health

80
On Track

Trial Health Score

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

Enrollment
37

participants targeted

Target at P25-P50 for phase_2

Geographic Reach
1 country

1 active site

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

First Submitted

Initial submission to the registry

December 7, 2004

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 8, 2004

Completed
2 months until next milestone

Study Start

First participant enrolled

February 1, 2005

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2005

Completed
Last Updated

January 24, 2013

Status Verified

January 1, 2013

Enrollment Period

7 months

First QC Date

December 7, 2004

Last Update Submit

January 23, 2013

Conditions

Male Breast CancerRecurrent Breast CancerStage IV Breast Cancer

Outcome Measures

Primary Outcomes (2)

  • Efficacy (complete and partial response) according to RECIST

    Up to 14 months

  • Progression-free survival

    From the first day of treatment to the first observation of disease progression or death due to any cause, assessed up to 14 months

Secondary Outcomes (1)

  • Toxicity as measured by the standard WHO grading system

    Up to 14 months after completion of study treatment

Study Arms (1)

Treatment (romidepsin)

EXPERIMENTAL

Patients receive FR901228 (depsipeptide) IV over 4 hours on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Drug: romidepsinOther: laboratory biomarker analysis

Interventions

romidepsinDRUG

Given IV

Also known as: FK228, FR901228, Istodax
Treatment (romidepsin)
laboratory biomarker analysisOTHER

Optional correlative studies

Treatment (romidepsin)

Eligibility Criteria

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

You may qualify if:

  • Histologically or cytologically confirmed breast cancer
  • Metastatic disease
  • Measurable disease
  • At least 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan
  • The following are not considered measurable disease:
  • Bone disease only
  • Pleural effusion
  • Peritoneal effusion
  • Must have received prior anthracycline (doxorubicin or epirubicin) and/or taxane (paclitaxel or docetaxel) as adjuvant therapy or for advanced disease
  • Therapy with high-dose regimens or bone marrow transplantation is considered 1 prior regimen
  • No known brain metastases
  • Hormone receptor status:
  • Not specified
  • Male or female
  • Performance status - ECOG 0-1
  • +39 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Breast Neoplasms, MaleBreast Neoplasms

Interventions

romidepsin

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Massimo Cristofanilli

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 7, 2004

First Posted

December 8, 2004

Study Start

February 1, 2005

Primary Completion

September 1, 2005

Last Updated

January 24, 2013

Record last verified: 2013-01

Locations

US(1)