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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Geron Corporation
ClinicalTrials.gov Identifier:
NCT01256762
First received: December 2, 2010
Last updated: January 27, 2013
Last verified: January 2013
  Purpose

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.


Condition Intervention Phase
Locally Recurrent or Metastatic Breast Cancer
Drug: Imetelstat sodium
Drug: Bevacizumab
Drug: Paclitaxel
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Geron Corporation:

Primary Outcome Measures:
  • Progression-free survival [ Time Frame: Occurring post randomization through end of study period (9 mos. after the last participant is randomized) ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Objective response [ Time Frame: Occurring post randomization through end of study period (9 mos. after the last participant is randomized) ] [ Designated as safety issue: No ]
    Objective response as determined by the investigator according to RECIST for patients with measurable disease at baseline.

  • Clinical benefit rate [ Time Frame: Occurring post randomization through end of study period (9 mos. after the last participant is randomized) ] [ Designated as safety issue: No ]
    Clinical response rate includes patients with objective response and stable disease lasting at least 6 months.


Enrollment: 166
Study Start Date: November 2010
Study Completion Date: December 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: GRN163L
Drug: Bevacizumab
Bevacizumab is administered at 15 mg/kg on day one of a 21 day cycle
Other Name: Avastin
Drug: Paclitaxel
Paclitaxel is administered at 90 mg/m2 on days one and eight of a 21 day cycle
Other Name: 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 Name: Avastin
Drug: Paclitaxel
Paclitaxel is administered at 90 mg/m2 on days one and eight of a 21 day cycle
Other Name: Taxol

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01256762

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

Publications:
Responsible Party: Geron Corporation
ClinicalTrials.gov Identifier: NCT01256762     History of Changes
Other Study ID Numbers: CP14B014
Study First Received: December 2, 2010
Last Updated: January 27, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Geron Corporation:
imetelstat
imetelstat sodium
GRN163L
telomerase inhibitor
telomerase inhibition
metastatic breast cancer
locally recurrent breast cancer
Bevacizumab
Paclitaxel
Avastin
Taxol
HER-2-negative
First-Line Chemotherapy
Second-Line Chemotherapy

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Paclitaxel
Bevacizumab
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors

ClinicalTrials.gov processed this record on September 15, 2014