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Phase I/II Trial of MK-0752 Followed by Docetaxel in Locally Advanced or Metastatic Breast Cancer: A Study by the Stem Cell Clinical Consortium


Phase 1/Phase 2
18 Years
N/A
Not Enrolling
Both
Metastatic Breast Cancer

Thank you

Trial Information

Phase I/II Trial of MK-0752 Followed by Docetaxel in Locally Advanced or Metastatic Breast Cancer: A Study by the Stem Cell Clinical Consortium


Inclusion Criteria:



- Men or women with metastatic (Stage IV) breast cancer, or with locally advanced
breast cancer (Stages IIIA > 10 cm, or Stages IIIB and IIIC) that did not respond to
first-line anthracycline-based chemotherapy, for whom docetaxel is a recommended
therapy

- Presence of measurable or evaluable disease

- Adequate organ function

- Ability to swallow intact study drug capsules

- Zubrod Performance Status of 0-1 with at least a 3 month life expectancy

- Appropriate time must have elapsed since prior anti-neoplastic therapy with
resolution of acute toxicity.

Exclusion Criteria:

- Concurrent treatment with hormonal therapy intended to treat cancer

- Radiotherapy within 7 days prior to first dose

- Symptomatic CNS, and/or epidural metastases or symptomatic carcinomatous meningitis
or with radiation treatment completed within the past 8 weeks

- Serious comorbid illness which will limit the ability of the patient to safely
receive anticancer treatment

- Patients who are pregnant or nursing

- Confounding factors present to provide misinterpretation of data (i.e., concurrent
malignancy)

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

dose limiting toxicity (DLT)

Outcome Time Frame:

first 21 days

Safety Issue:

Yes

Principal Investigator

Anne Schott, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

The University of Michigan Comprehensive Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

UMCC 2006.119

NCT ID:

NCT00645333

Start Date:

March 2008

Completion Date:

October 2012

Related Keywords:

  • Metastatic Breast Cancer
  • Women or men with locally advanced or metastatic breast cancer that did not respond to first-line anthracycline-based therapy
  • Breast Neoplasms

Name

Location
Baylor College of Medicine Houston, Texas  77030
University of Michigan Cancer Center Ann Arbor, Michigan  48109
Dana Farber Cancer Institute Boston, Massachusetts  02115