Imetelstat in Combination With Paclitaxel (With or Without Bevacizumab) in Patients With Locally Recurrent or Metastatic Breast Cancer
NCT ID: NCT01256762
Last Updated: 2016-01-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
166 participants
INTERVENTIONAL
2010-11-30
2012-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Imetelstat + Paclitaxel (with or without bevacizumab)
Imetelstat sodium
Imetelstat is administered at a dose of 300 mg/m2 on day one of a 21 day cycle.
Bevacizumab
Bevacizumab is administered at 15 mg/kg on day one of a 21 day cycle
Paclitaxel
Paclitaxel is administered at 90 mg/m2 on days one and eight of a 21 day cycle
Paclitaxel (with or without bevacizumab) alone
Bevacizumab
Bevacizumab is administered at 15 mg/kg on day one of a 21 day cycle
Paclitaxel
Paclitaxel is administered at 90 mg/m2 on days one and eight of a 21 day cycle
Interventions
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Imetelstat sodium
Imetelstat is administered at a dose of 300 mg/m2 on day one of a 21 day cycle.
Bevacizumab
Bevacizumab is administered at 15 mg/kg on day one of a 21 day cycle
Paclitaxel
Paclitaxel is administered at 90 mg/m2 on days one and eight of a 21 day cycle
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
18 Years
ALL
No
Sponsors
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Geron Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Ted Shih, PharmD
Role: STUDY_DIRECTOR
Geron Corporation
Kathy Miller, MD
Role: PRINCIPAL_INVESTIGATOR
Indiana University School of Medicine
Locations
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Clearview Cancer Center
Huntsville, Alabama, United States
Alta Bates Summit Medical Center
Berkeley, California, United States
Southbay Oncology Hematology Partners
Campbell, California, United States
Cancer Care Associates
Fresno, California, United States
Memorial Miller Hospital
Long Beach, California, United States
St. Joseph Hospital
Orange, California, United States
Desert Regional Comprehensive Cancer Center
Palm Springs, California, United States
UC San Diego
San Diego, California, United States
Redwood Regional Medical Group
Santa Rosa, California, United States
Univ. Colorado at Denver
Aurora, Colorado, United States
Connecticut Oncology & Hematology
Torrington, Connecticut, United States
Medical Oncology Hematology
Waterbury, Connecticut, United States
Florida Oncology Associates
Jacksonville, Florida, United States
Hematology Oncology Associates
Port Saint Lucie, Florida, United States
H. Lee Moffitt Cancer Center
Tampa, Florida, United States
Northeast Georgia Cancer Care
Athens, Georgia, United States
Peachtree Hematology Oncology
Atlanta, Georgia, United States
Emory University
Atlanta, Georgia, United States
Northeast Georgia Medical Center
Gainesville, Georgia, United States
Central Georgia Cancer Care
Macon, Georgia, United States
Summit Cancer Care
Savannah, Georgia, United States
Kootenai Medical Center
Post Falls, Idaho, United States
Ingalls Memorial Hospital
Chicago, Illinois, United States
Rush University
Chicago, Illinois, United States
Mid Illinois Hematology & Oncology
Normal, Illinois, United States
Cancer Treatment Centers of America
Zion, Illinois, United States
Indiana University
Indianapolis, Indiana, United States
Community Hospitals of Indiana
Indianapolis, Indiana, United States
Horizon Oncology Center
Lafayette, Indiana, United States
Cancer Center of Kansas
Wichita, Kansas, United States
Montgomery Cancer Care
Mount Sterling, Kentucky, United States
Michigan State University
East Lansing, Michigan, United States
New Mexico Cancer Center
Albuquerque, New Mexico, United States
Prohealth Associates
Lake Success, New York, United States
Stony Brook University
Stony Brook, New York, United States
Carolinas Hematology/Oncology
Charlotte, North Carolina, United States
Moses Cone Medical System
Greensboro, North Carolina, United States
Case Western Reserve Univ.
Cleveland, Ohio, United States
Mercy Physicians of Oklahoma
Oklahoma City, Oklahoma, United States
Cancer Care Associates
Tulsa, Oklahoma, United States
Kaiser Northwest
Portland, Oregon, United States
Pinnacle Health
Harrisburg, Pennsylvania, United States
Penn. State Univ.
Hershey, Pennsylvania, United States
The Jones Clinic
Germantown, Tennessee, United States
The West Clinic
Memphis, Tennessee, United States
Scott & White Healthcare
Temple, Texas, United States
Northern Utah Associates
Ogden, Utah, United States
Peninsula Cancer Institute
Newport News, Virginia, United States
Medical Oncology Associates
Spokane, Washington, United States
Northwest Medical Specialties
Tacoma, Washington, United States
Grand River Regional Cancer Centre
Kitchener, Ontario, Canada
Stronach Regional Cancer Centre at Southlake
Newmarket, Ontario, Canada
The Ottawa Hospital Cancer Centre
Ottawa, Ontario, Canada
Sunnybrook Health Services Centre
Toronto, Ontario, Canada
McGill University
Montreal, Quebec, Canada
Countries
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References
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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.
Goldblatt 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.
Herbert 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.
Other Identifiers
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CP14B014
Identifier Type: -
Identifier Source: org_study_id
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