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

December 22, 2015 updated by: Geron Corporation

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

166

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Kitchener, Ontario, Canada, N2G 1G3
        • Grand River Regional Cancer Centre
      • Newmarket, Ontario, Canada, L3Y 2P9
        • Stronach Regional cancer Centre at Southlake
      • Ottawa, Ontario, Canada, K1H 8L6
        • The Ottawa Hospital Cancer Centre
      • Toronto, Ontario, Canada, M4N 3M5
        • Sunnybrook Health Services Centre
    • Quebec
      • Montreal, Quebec, Canada, H2W 1S6
        • McGill University
  • United States
    • Alabama
      • Huntsville, Alabama, United States, 35805
        • Clearview Cancer Center
    • California
      • Berkeley, California, United States, 94704
        • Alta Bates Summit Medical Center
      • Campbell, California, United States, 95008
        • Southbay Oncology Hematology Partners
      • Fresno, California, United States, 93720
        • Cancer Care Associates
      • Long Beach, California, United States, 90806
        • Memorial Miller Hospital
      • Orange, California, United States, 92868
        • St. Joseph Hospital
      • Palm Springs, California, United States, 92262
        • Desert Regional Comprehensive Cancer Center
      • San Diego, California, United States, 92093
        • UC San Diego
      • Santa Rosa, California, United States, 95403
        • Redwood Regional Medical Group
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Univ. Colorado at Denver
    • Connecticut
      • Torrington, Connecticut, United States, 06790
        • Connecticut Oncology & Hematology
      • Waterbury, Connecticut, United States, 06708
        • Medical Oncology Hematology
    • Florida
      • Jacksonville, Florida, United States, 32256
        • Florida Oncology Associates
      • Port St. Lucie, Florida, United States, 34952
        • Hematology Oncology Associates
      • Tampa, Florida, United States, 33612
        • H. Lee Moffitt Cancer Center
    • Georgia
      • Athens, Georgia, United States, 30607
        • Northeast Georgia Cancer Care
      • Atlanta, Georgia, United States, 30322
        • Emory University
      • Atlanta, Georgia, United States, 30318
        • Peachtree Hematology Oncology
      • Gainesville, Georgia, United States, 30501
        • Northeast Georgia Medical Center
      • Macon, Georgia, United States, 31201
        • Central Georgia Cancer Care
      • Savannah, Georgia, United States, 31405
        • Summit Cancer Care
    • Idaho
      • Post Falls, Idaho, United States, 83854
        • Kootenai Medical Center
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Rush University
      • Chicago, Illinois, United States, 60426
        • Ingalls Memorial Hospital
      • Normal, Illinois, United States, 61761
        • Mid Illinois Hematology & Oncology
      • Zion, Illinois, United States, 60099
        • Cancer Treatment Centers of America
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Indiana University
      • Indianapolis, Indiana, United States, 46268
        • Community Hospitals of Indiana
      • Lafayette, Indiana, United States, 47905
        • Horizon Oncology Center
    • Kansas
      • Wichita, Kansas, United States, 67214
        • Cancer Center of Kansas
    • Kentucky
      • Mount Sterling, Kentucky, United States, 40353
        • Montgomery Cancer Care
    • Michigan
      • East Lansing, Michigan, United States, 48823
        • Michigan State University
    • New Mexico
      • Albuquerque, New Mexico, United States, 87109
        • New Mexico Cancer Center
    • New York
      • Lake Success, New York, United States, 11402
        • Prohealth Associates
      • Stony Brook, New York, United States, 11794
        • Stony Brook University
    • North Carolina
      • Charlotte, North Carolina, United States, 28203
        • Carolinas Hematology/Oncology
      • Greensboro, North Carolina, United States, 27403
        • Moses Cone Medical System
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • Case Western Reserve Univ.
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73120
        • Mercy Physicians Of Oklahoma
      • Tulsa, Oklahoma, United States, 74136
        • Cancer Care Associates
    • Oregon
      • Portland, Oregon, United States, 97232
        • Kaiser Northwest
    • Pennsylvania
      • Harrisburg, Pennsylvania, United States, 17110
        • Pinnacle Health
      • Hershey, Pennsylvania, United States, 17033
        • Penn. State Univ.
    • Tennessee
      • Germantown, Tennessee, United States, 38138
        • The Jones Clinic
      • Memphis, Tennessee, United States, 38120
        • The West Clinic
    • Texas
      • Temple, Texas, United States, 76508
        • Scott & White Healthcare
    • Utah
      • Ogden, Utah, United States, 84403
        • Northern Utah Associates
    • Virginia
      • Newport News, Virginia, United States, 23601
        • Peninsula Cancer Institute
    • Washington
      • Spokane, Washington, United States, 99208
        • Medical Oncology Associates
      • Tacoma, Washington, United States, 98405
        • Northwest Medical Specialties

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria

  • Histologically or cytologically confirmed adenocarcinoma of the breast that is either locally recurrent or metastatic. Locally recurrent disease must not be amenable to surgical resection or radiation with curative intent
  • Either have not received chemotherapy or may have had one prior non-taxane chemotherapy regimen for metastatic disease (there are no restrictions on prior hormonal therapy)
  • Prior use of bevacizumab is allowed provided that it was not administered in combination with a taxane
  • ECOG performance status 0-1

  • Adequate bone marrow reserve as indicated by:

    • ANC > 1500/uL (without use of growth factors within 7 days)
    • Platelet count > 100,000 (without transfusion in prior 7 days)
    • Hemoglobin > 9.0 g/dL

Exclusion Criteria:

  • Women who are pregnant or breast feeding
  • Locally recurrent disease amenable to resection with curative intent
  • HER-2-positive breast cancer
  • Active central nervous system (CNS) metastatic disease including those patients receiving radiotherapy and/or steroid treatment (within the last 3 months)
  • Prior adjuvant or neoadjuvant taxane chemotherapy within 12 months prior of first relapse
  • Investigational therapy within 4 weeks of first study drug administration
  • Prior radiation, cytotoxic, or hormonal therapy within 2 weeks of first study drug administration
  • Therapeutic anti-coagulation or regular use of anti-platelet therapy within 2 weeks prior to first study drug administration (low dose anti-coagulant therapy to maintain patency of a vascular access device is allowed)
  • Grade ≥ 2 neuropathy
  • Uncontrolled clinically significant atrial or ventricular arrhythmias (unless pacemaker in place)
  • Severe conduction disturbance including clinically significant QTC prolongation > 450 ms (unless pacemaker in place)
  • Active or chronically recurrent bleeding (e.g., active peptic ulcer disease)
  • Clinically relevant active infection
  • Known positive serology for human immunodeficiency virus (HIV)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Imetelstat + Paclitaxel (with or without bevacizumab)
Drug: Imetelstat sodium
Imetelstat is administered at a dose of 300 mg/m2 on day one of a 21 day cycle.
Other Names:
  • GRN163L
Drug: Bevacizumab
Bevacizumab is administered at 15 mg/kg on day one of a 21 day cycle
Other Names:
  • Avastin
Drug: Paclitaxel
Paclitaxel is administered at 90 mg/m2 on days one and eight of a 21 day cycle
Other Names:
  • Taxol
EXPERIMENTAL: Paclitaxel (with or without bevacizumab) alone
Drug: Bevacizumab
Bevacizumab is administered at 15 mg/kg on day one of a 21 day cycle
Other Names:
  • Avastin
Drug: Paclitaxel
Paclitaxel is administered at 90 mg/m2 on days one and eight of a 21 day cycle
Other Names:
  • Taxol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-free survival
Time Frame: Occurring post randomization through end of study period (9 mos. after the last participant is randomized)
Defined as the time from randomization to documented disease progression, as determined by the investigator's assessment according to RECIST, or death from any cause, whichever occurs first.
Occurring post randomization through end of study period (9 mos. after the last participant is randomized)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective response
Time Frame: Occurring post randomization through end of study period (9 mos. after the last participant is randomized)
Objective response as determined by the investigator according to RECIST for patients with measurable disease at baseline.
Occurring post randomization through end of study period (9 mos. after the last participant is randomized)
Clinical benefit rate
Time Frame: Occurring post randomization through end of study period (9 mos. after the last participant is randomized)
Clinical response rate includes patients with objective response and stable disease lasting at least 6 months.
Occurring post randomization through end of study period (9 mos. after the last participant is randomized)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Geron Corporation

Investigators

  • Study Director: Ted Shih, PharmD, Geron Corporation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2010

Primary Completion (ACTUAL)

October 1, 2012

Study Completion (ACTUAL)

December 1, 2012

Study Registration Dates

First Submitted

December 2, 2010

First Submitted That Met QC Criteria

December 7, 2010

First Posted (ESTIMATE)

December 9, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

January 26, 2016

Last Update Submitted That Met QC Criteria

December 22, 2015

Last Verified

December 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CP14B014

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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