Spots Global Cancer Trial Database for A Phase 1b/2a, Open-Label, Multi-Center Study of Tivozanib (AV-951) in Combination With Paclitaxel in Subjects With Advanced or Metastatic Breast Cancer
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Trial Identification
Brief Title: A Phase 1b/2a, Open-Label, Multi-Center Study of Tivozanib (AV-951) in Combination With Paclitaxel in Subjects With Advanced or Metastatic Breast Cancer
Official Title: A Phase 1b/2a, Open-Label, Multi-Center Study of Tivozanib (AV-951) in Combination With Paclitaxel in Subjects With Advanced or Metastatic Breast Cancer
Study ID: NCT00717340
Conditions
Interventions
Study Description
Brief Summary: This is a standard Phase 1b and 2a, multi-center, study design that will examine the safety, tolerability, maximum tolerated dose, and overall response rate of tivozanib (AV-951) and paclitaxel in a breast cancer.
Detailed Description: This is a standard Phase 1b and 2a, multi-center, study design that will examine the safety, tolerability, maximum tolerated dose, and overall response rate of tivozanib (AV-951) and paclitaxel in a breast cancer. In the Phase 1b study, only the doses of tivozanib (AV-951) will be escalated from 0.5 mg/day to 1.5 mg /day. All subjects will receive doses of weekly paclitaxel chemotherapy. The Phase 2a study portion of the study was not conducted.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
Dana Farber Cancer Institute, Inc., Boston, Massachusetts, United States
Memorial Sloan-Kettering Cancer Center, New York, New York, United States
Universitaetsklinikum Essen, Essen, , Germany
Contact Details
Name: Joshua Zhang, M.D.
Affiliation: AVEO Pharmaceuticals, Inc.
Role: STUDY_DIRECTOR
Name: Erica Mayer, M.D.
Affiliation: Dana Farber Cancer Institute, Inc.
Role: PRINCIPAL_INVESTIGATOR
Name: Max E. Scheulen, M.D.
Affiliation: Universitaetsklinikum Essen, Germany
Role: PRINCIPAL_INVESTIGATOR
Name: Maura Dickler, M.D.
Affiliation: Memorial Sloan Kettering Cancer Center
Role: PRINCIPAL_INVESTIGATOR
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