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A Phase II Study Of Intravenous Edotecarin (PHA-782615) In Patients With Anthracycline- And Taxane Resistant Metastatic Breast Cancer


Phase 2
18 Years
N/A
Not Enrolling
Female
Breast Neoplasms, Neoplasm Metastasis

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Trial Information

A Phase II Study Of Intravenous Edotecarin (PHA-782615) In Patients With Anthracycline- And Taxane Resistant Metastatic Breast Cancer


Inclusion Criteria:



- Locally advanced or metastatic breast cancer not amenable to surgery or radiation
with curative intent

- Must have received any chemotherapy regimen in the past

- Evidence of tumor resistance to last chemotherapy defined as progression after 6
months of previous chemotherapy for advanced disease

- Must have measurable (by imaging techniques) disease

- Adequate bone marrow, liver and renal function

- Must provide evidence of informed consent and willingness and ability to comply with
scheduled visits, treatment plan and study procedures.

Exclusion Criteria:

- Received more than 2 prior chemotherapy regimens for metastatic disease

- Received in the past another drug of the same class as the investigational drug, i.e.
topoisomerase I inhibitor

- Enrolled in another clinical intervention study

- Pregnancy, breast feeding, fertile women refusing to use reliable contraceptive
methods

- Cardiac or thrombotic event in the last 12 months

- Brain metastases

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To assess the anti-tumor activity of single-agent Edotecarin by determining the objective response rate

Principal Investigator

Pfizer CT.gov Call Center

Investigator Role:

Study Director

Investigator Affiliation:

Pfizer

Authority:

United States: Food and Drug Administration

Study ID:

EDOABC-4439-001

NCT ID:

NCT00067314

Start Date:

June 2003

Completion Date:

June 2007

Related Keywords:

  • Breast Neoplasms
  • Neoplasm Metastasis
  • Breast Neoplasms
  • Neoplasms
  • Neoplasm Metastasis

Name

Location

Pfizer Investigational SiteCincinnait, Ohio  45236
Pfizer Investigational SiteBronx, New York  10461
Pfizer Investigational SiteBristol, Tennessee  37620