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
1 other identifier
interventional
166
2 countries
55
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Nov 2010
55 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2010
CompletedFirst Submitted
Initial submission to the registry
December 2, 2010
CompletedFirst Posted
Study publicly available on registry
December 9, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2012
CompletedJanuary 26, 2016
December 1, 2015
1.9 years
December 2, 2010
December 22, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Progression-free survival
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 Outcomes (2)
Objective response
Occurring post randomization through end of study period (9 mos. after the last participant is randomized)
Clinical benefit rate
Occurring post randomization through end of study period (9 mos. after the last participant is randomized)
Study Arms (2)
Imetelstat + Paclitaxel (with or without bevacizumab)
EXPERIMENTALPaclitaxel (with or without bevacizumab) alone
EXPERIMENTALInterventions
Imetelstat is administered at a dose of 300 mg/m2 on day one of a 21 day cycle.
Bevacizumab is administered at 15 mg/kg on day one of a 21 day cycle
Paclitaxel is administered at 90 mg/m2 on days one and eight of a 21 day cycle
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (55)
Clearview Cancer Center
Huntsville, Alabama, 35805, United States
Alta Bates Summit Medical Center
Berkeley, California, 94704, United States
Southbay Oncology Hematology Partners
Campbell, California, 95008, United States
Cancer Care Associates
Fresno, California, 93720, United States
Memorial Miller Hospital
Long Beach, California, 90806, United States
St. Joseph Hospital
Orange, California, 92868, United States
Desert Regional Comprehensive Cancer Center
Palm Springs, California, 92262, United States
UC San Diego
San Diego, California, 92093, United States
Redwood Regional Medical Group
Santa Rosa, California, 95403, United States
Univ. Colorado at Denver
Aurora, Colorado, 80045, United States
Connecticut Oncology & Hematology
Torrington, Connecticut, 06790, United States
Medical Oncology Hematology
Waterbury, Connecticut, 06708, United States
Florida Oncology Associates
Jacksonville, Florida, 32256, United States
Hematology Oncology Associates
Port Saint Lucie, Florida, 34952, United States
H. Lee Moffitt Cancer Center
Tampa, Florida, 33612, United States
Northeast Georgia Cancer Care
Athens, Georgia, 30607, United States
Peachtree Hematology Oncology
Atlanta, Georgia, 30318, United States
Emory University
Atlanta, Georgia, 30322, United States
Northeast Georgia Medical Center
Gainesville, Georgia, 30501, United States
Central Georgia Cancer Care
Macon, Georgia, 31201, United States
Summit Cancer Care
Savannah, Georgia, 31405, United States
Kootenai Medical Center
Post Falls, Idaho, 83854, United States
Ingalls Memorial Hospital
Chicago, Illinois, 60426, United States
Rush University
Chicago, Illinois, 60612, United States
Mid Illinois Hematology & Oncology
Normal, Illinois, 61761, United States
Cancer Treatment Centers of America
Zion, Illinois, 60099, United States
Indiana University
Indianapolis, Indiana, 46202, United States
Community Hospitals of Indiana
Indianapolis, Indiana, 46268, United States
Horizon Oncology Center
Lafayette, Indiana, 47905, United States
Cancer Center of Kansas
Wichita, Kansas, 67214, United States
Montgomery Cancer Care
Mount Sterling, Kentucky, 40353, United States
Michigan State University
East Lansing, Michigan, 48823, United States
New Mexico Cancer Center
Albuquerque, New Mexico, 87109, United States
Prohealth Associates
Lake Success, New York, 11402, United States
Stony Brook University
Stony Brook, New York, 11794, United States
Carolinas Hematology/Oncology
Charlotte, North Carolina, 28203, United States
Moses Cone Medical System
Greensboro, North Carolina, 27403, United States
Case Western Reserve Univ.
Cleveland, Ohio, 44106, United States
Mercy Physicians of Oklahoma
Oklahoma City, Oklahoma, 73120, United States
Cancer Care Associates
Tulsa, Oklahoma, 74136, United States
Kaiser Northwest
Portland, Oregon, 97232, United States
Pinnacle Health
Harrisburg, Pennsylvania, 17110, United States
Penn. State Univ.
Hershey, Pennsylvania, 17033, United States
The Jones Clinic
Germantown, Tennessee, 38138, United States
The West Clinic
Memphis, Tennessee, 38120, United States
Scott & White Healthcare
Temple, Texas, 76508, United States
Northern Utah Associates
Ogden, Utah, 84403, United States
Peninsula Cancer Institute
Newport News, Virginia, 23601, United States
Medical Oncology Associates
Spokane, Washington, 99208, United States
Northwest Medical Specialties
Tacoma, Washington, 98405, United States
Grand River Regional Cancer Centre
Kitchener, Ontario, N2G 1G3, Canada
Stronach Regional Cancer Centre at Southlake
Newmarket, Ontario, L3Y 2P9, Canada
The Ottawa Hospital Cancer Centre
Ottawa, Ontario, K1H 8L6, Canada
Sunnybrook Health Services Centre
Toronto, Ontario, M4N 3M5, Canada
McGill University
Montreal, Quebec, H2W 1S6, Canada
Related Publications (3)
Hochreiter AE, Xiao H, Goldblatt EM, Gryaznov SM, Miller KD, Badve S, Sledge GW, Herbert BS. Telomerase template antagonist GRN163L disrupts telomere maintenance, tumor growth, and metastasis of breast cancer. Clin Cancer Res. 2006 May 15;12(10):3184-92. doi: 10.1158/1078-0432.CCR-05-2760.
PMID: 16707619BACKGROUNDGoldblatt EM, Gentry ER, Fox MJ, Gryaznov SM, Shen C, Herbert BS. The telomerase template antagonist GRN163L alters MDA-MB-231 breast cancer cell morphology, inhibits growth, and augments the effects of paclitaxel. Mol Cancer Ther. 2009 Jul;8(7):2027-35. doi: 10.1158/1535-7163.MCT-08-1188. Epub 2009 Jun 9.
PMID: 19509275BACKGROUNDHerbert BS, Wright WE, Shay JW. Telomerase and breast cancer. Breast Cancer Res. 2001;3(3):146-9. doi: 10.1186/bcr288. Epub 2001 Feb 22.
PMID: 11305948BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Ted Shih, PharmD
Geron Corporation
- PRINCIPAL INVESTIGATOR
Kathy Miller, MD
Indiana University School of Medicine
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 2, 2010
First Posted
December 9, 2010
Study Start
November 1, 2010
Primary Completion
October 1, 2012
Study Completion
December 1, 2012
Last Updated
January 26, 2016
Record last verified: 2015-12