A Phase II, Open-Label, Multi-Center Study of ANG1005 in Breast Cancer Patients With Recurrent Brain Metastases
Description
Brief Summary
This is a Phase 2 study to see if an investigational drug, ANG1005, can shrink tumor cells in
breast cancer patients with recurrent brain metastases.
Phase
Phase 2 - takes the treatment one step further, assessing the activity of a particular therapy in a disease, often building upon leads from the Phase I trial. While patients are generally required to be previously untreated, participation in a Phase II trial doesn't usually preclude the patient from getting the standard treatment after they've received the investigational agent. At best they are allowed to get a new drug they wouldn't be able to get otherwise that may turn out to be better for their disease.Inclusion and Exclusion Criteria
- ≥ 18 years old
- Breast cancer
- Recurrent brain metastases from breast cancer
- At least one radiologically-confirmed and measurable metastatic brain lesion ( ≥ 0.5 cm)
- Neurologically stable
- Karnofsky Performance Status (KPS) score ≥ 70
- Adequate hematology and serum chemistry laboratory test results
- Expected survival of ≥ 3 months
- Prior treatment with ANG1005/GRN1005
- Evidence of symptomatic intracranial hemorrhage
- Pregnancy or lactation
- Inadequate bone marrow reserve
- Any evidence of severe or uncontrolled diseases
- Patients with the presence of an infection including abscess or fistulae, or known infection with hepatitis B or C or HIV
- History of interstitial lung disease or evidence of clinically significant interstitial lung disease
- Severe cardiac conduction disturbance
- Central nervous system (CNS) disease requiring immediate neurosurgery intervention
- Known severe hypersensitivity or allergy to paclitaxel or any of its components
Sites
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California
- University of California - LAC Medical Center, Los Angeles, California, 90033
- University of Southern California - Norris Comprehensive Cancer Center, Los Angeles, California, 90033
-
Texas
- Univeristy of Texas Health Science Center in San Antonio, San Antonio, Texas, 78229
-
Illinois
- Northwestern University, Chicago, Illinois, 60611
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Michigan
- Cancer & Hematology Centers of Western Michigan, Grand Rapids, Michigan, 49503