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1B-14-2: A Phase II, Open-Label, Multi-Center Study of ANG1005 in Breast Cancer Patients with Recurrent Brain Metastases

Description

See above.

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

  • Prior treatment with ANG1005/GRN1005
  • 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
  • CNS disease requiring immediate neurosurgery intervention (e.g., resection, shunt placement, etc.)
  • Known allergy to paclitaxel or any of its components

Sites

  • California

    • University of Southern California - Norris Comprehensive Cancer Center, Los Angeles, California, 90033
    • University of California - LAC Medical 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
  • Michigan

    • Cancer & Hematology Centers of Western Michigan, Grand Rapids, Michigan, 49503
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