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

NCT01256762 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 166

Last updated 2016-01-26

No results posted yet for this study

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.

Conditions

  • Locally Recurrent or Metastatic Breast Cancer

Interventions

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

Sponsors & Collaborators

  • Geron Corporation

    lead INDUSTRY

Principal Investigators

  • Ted Shih, PharmD · Geron Corporation

  • Kathy Miller, MD · Indiana University School of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-11-30
Primary Completion
2012-10-31
Completion
2012-12-31

Countries

  • United States
  • Canada

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01256762 on ClinicalTrials.gov