NCT00717340

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: AVEO Pharmaceuticals, Inc. · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Metastatic Breast Cancer

Interventions

Type	Name	Description
DRUG	tivozanib (AV-951) + paclitaxel	Tivozanib (AV-951): Subjects in the Phase 1b study will receive 1 dose of tivozanib (AV-951) on Day -5 (± 2 days) for PK sampling prior to Cycle 1 only. Thereafter in the Phase 1b and 2a study, subjects will receive tivozanib (AV-951) once daily for 3 weeks beginning on Day 1, followed by 1 week off treatment (1 cycle = 4 weeks). On days when paclitaxel and tivozanib (AV-951) are co-administered, AV-951 will be administered immediately following the end of the paclitaxel infusion. Paclitaxel: Phase 1b study and Phase 2a study: All subjects will receive IV paclitaxel 90 mg/m2, administered over 1 hour once a week for 3 weeks, followed by 1 week off (1 cycle = 4 weeks).

Timeline

• Start date: 2009-02-01
• Primary completion: 2011-01-01
• Completion: 2011-02-01
• First posted: 2008-07-17
• Last updated: 2012-06-28

Locations

3 sites across 2 countries: United States, Germany