NCT01256762

Imetelstat in Combination With Paclitaxel (With or Without Bevacizumab) in Patients With Locally Recurrent or Metastatic Breast Cancer

A Randomized Phase II Study Of Imetelstat (GRN163L) In Combination With Paclitaxel (With Or Without Bevacizumab) in Patients With Locally Recurrent Or Metastatic Breast Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 166 (actual)
• Sponsor: Geron Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the efficacy and safety of treatment with imetelstat + paclitaxel (with or without bevacizumab) versus paclitaxel (with or without bevacizumab) alone for patients with locally recurrent or metastatic breast cancer who have not received chemotherapy or have received one non-taxane based chemotherapy for metastatic breast cancer.

Detailed description

Patients will be randomized in a 1:1 ratio to imetelstat + paclitaxel (with or without bevacizumab) versus paclitaxel (with or without bevacizumab) alone.

Conditions

• Locally Recurrent or Metastatic Breast Cancer

Interventions

Type	Name	Description
DRUG	Imetelstat sodium	Imetelstat is administered at a dose of 300 mg/m2 on day one of a 21 day cycle.
DRUG	Bevacizumab	Bevacizumab is administered at 15 mg/kg on day one of a 21 day cycle
DRUG	Paclitaxel	Paclitaxel is administered at 90 mg/m2 on days one and eight of a 21 day cycle

Timeline

• Start date: 2010-11-01
• Primary completion: 2012-10-01
• Completion: 2012-12-01
• First posted: 2010-12-09
• Last updated: 2016-01-26

Locations

55 sites across 2 countries: United States, Canada