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A Phase I Study of MK0752, a Notch Inhibitor, in Patients With Metastatic or Locally Advanced Breast Cancer and Other Solid Tumors

Phase 1
18 Years
Not Enrolling
Advanced Breast Cancer, Other Solid Tumors

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Trial Information

A Phase I Study of MK0752, a Notch Inhibitor, in Patients With Metastatic or Locally Advanced Breast Cancer and Other Solid Tumors

Inclusion Criteria:

- Women or men greater than or equal to 18 years of age

- ECOG status less than or equal to 2 (a measurement to determine your ability to
perform daily activities)

- In Parts I, III, and IV, patient must have a histologically confirmed, metastatic or
locally advanced solid tumor that has failed to respond to standard therapy,
progressed despite standard therapy, or for which standard therapy does not exist.
There is no limit on the number of prior treatment regimens

- In Part II, only breast cancer patients are eligible

- In Part V, only patients with Numb negative breast cancer (i.e., tumor shows Numb
immunoreactivity in less than 10% of the neoplastic cells assessed) are eligible

- Patient has recovered from and is at least 2 weeks from previous antineoplastic
therapy, including chemotherapy, biological therapy (including Herceptin), hormonal
therapy, radiotherapy, or surgery

Exclusion Criteria:

- Patient has had an investigational treatment in the preceding 21 days

- Uncontrolled congestive heart failure or myocardial infarction (heart attack) within
3 months of study start

- History of hepatitis B or C or HIV

- Patient has the presence of clinically apparent central nervous system metastases or
carcinomatous meningitis. Patients with CNS metastases who have completed a course
of radiotherapy and are clinically stable in the judgment of the investigator are

- Patients with "currently active" second malignancy, other than non-melanoma skin
cancer, should not be enrolled. Patients are not considered to have a "currently
active" malignancy if they have completed therapy for prior malignancy and are
considered by their physician to be at <30% risk of relapse

Type of Study:


Study Design:

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

Outcome Measure:

Safety and tolerability; MTD will be established

Outcome Time Frame:

Day 1 to Day 28

Safety Issue:


Principal Investigator

Medical Monitor

Investigator Role:

Study Director

Investigator Affiliation:



United States: Food and Drug Administration

Study ID:




Start Date:

April 2005

Completion Date:

August 2011

Related Keywords:

  • Advanced Breast Cancer
  • Other Solid Tumors
  • Advanced Breast Cancer
  • Solid Tumors
  • Advanced Solid Tumors
  • Breast Neoplasms
  • Neoplasms