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A Phase Ib/IIa Study of AV-951 in Combination with Paclitaxel in Patients with Advanced or Metastatic Breast Cancer

[Protocol 08-136]

Full Title :
A PHASE 1B/2A, OPEN-LABEL, MULTI-CENTER STUDY OF AV-951 IN COMBINATION WITH PACLITAXEL IN SUBJECTS WITH ADVANCED OR METASTATIC BREAST CANCER
Purpose :

The purpose of this study is to evaluate this safety and effectiveness of an investigational drug called AV-951 when given in combination with paclitaxel (Taxol®) in women with advanced breast cancer. AV-951 is designed to fight cancer by cutting off the blood supply to tumors. Without blood, the cancer cannot get the nutrients it needs to grow.

Researchers will first determine the highest dose of AV-951 that can be given safely with paclitaxel. They will then determine the ability of this drug combination to slow the growth of advanced or metastatic breast cancer.

Eligibility :

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients in the phase Ib portion of the study must have a confirmed diagnosis of progressive breast cancer and may have had up to 4 prior chemotherapy regimens (including only 1 previous taxane-based treatment for metastatic disease).
  • Patients in the phase IIa portion of the study must have a confirmed diagnosis of metastatic breast cancer and no prior chemotherapy or biological therapy for metastatic disease.
  • Patients must not have had previous treatment with sunitinib, sorafenib, AZ2171, AG013736, GW786034, ZD6474 AMG706, PTK/ZK and other similar agents that target VEGF. Prior bevacizumab treatment is permitted as long as 4 or more weeks have passed between the completion of treatment and entry into the study.
  • At least 3 weeks must have passed since completion of other forms of treatment (with the exception of hormonal therapy) and entry into the study.
  • Patients must not be confined to a bed or chair for more than half of their normal waking hours.
  • Patients must be age 18 or older.

For more information and to inquire about eligibility for this study, please contact Dr. Maura Dickler at 646-888-5456.

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