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

Conditions

• Locally Recurrent or Metastatic Breast Cancer

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

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

Study Details

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.

Key Dates

First listed

Dec 9, 2010

Start date

Nov 30, 2010

Status verified

Dec 2015

Primary completion

Oct 31, 2012

Completion

Dec 31, 2012

Study Design

Enrollment

166 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Imetelstat + Paclitaxel (with or without bevacizumab)
• Experimental: Paclitaxel (with or without bevacizumab) alone

Primary Outcome Measure

Progression-free survival [ Time Frame: Occurring post randomization through end of study period (9 mos. after the last participant is randomized) ]

Locations (50)

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