Imetelstat in Combination With Paclitaxel (With or Without Bevacizumab) in Patients With Locally Recurrent or Metastatic Breast Cancer
- Conditions
- Locally Recurrent or Metastatic Breast Cancer
- Interventions
- Registration Number
- NCT01256762
- Lead Sponsor
- Geron Corporation
- 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 166
Not provided
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Imetelstat + Paclitaxel (with or without bevacizumab) Imetelstat sodium - Imetelstat + Paclitaxel (with or without bevacizumab) Bevacizumab - Paclitaxel (with or without bevacizumab) alone Bevacizumab - Paclitaxel (with or without bevacizumab) alone Paclitaxel - Imetelstat + Paclitaxel (with or without bevacizumab) Paclitaxel -
- Primary Outcome Measures
Name Time Method Progression-free survival 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.
- Secondary Outcome Measures
Name Time Method Clinical benefit rate 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.
Objective response 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.
Trial Locations
- Locations (54)
Clearview Cancer Center
🇺🇸Huntsville, Alabama, United States
Medical Oncology Hematology
🇺🇸Waterbury, Connecticut, United States
Mid Illinois Hematology & Oncology
🇺🇸Normal, Illinois, United States
Kootenai Medical Center
🇺🇸Post Falls, Idaho, United States
Ingalls Memorial Hospital
🇺🇸Chicago, Illinois, United States
Rush University
🇺🇸Chicago, Illinois, United States
Case Western Reserve Univ.
🇺🇸Cleveland, Ohio, United States
UC San Diego
🇺🇸San Diego, California, United States
Alta Bates Summit Medical Center
🇺🇸Berkeley, California, United States
Desert Regional Comprehensive Cancer Center
🇺🇸Palm Springs, California, United States
Emory University
🇺🇸Atlanta, Georgia, United States
Redwood Regional Medical Group
🇺🇸Santa Rosa, California, United States
Northeast Georgia Cancer Care
🇺🇸Athens, Georgia, United States
Northeast Georgia Medical Center
🇺🇸Gainesville, Georgia, United States
Horizon Oncology Center
🇺🇸Lafayette, Indiana, United States
Montgomery Cancer Care
🇺🇸Mount Sterling, Kentucky, United States
Cancer Treatment Centers of America
🇺🇸Zion, Illinois, United States
Central Georgia Cancer Care
🇺🇸Macon, Georgia, United States
Summit Cancer Care
🇺🇸Savannah, Georgia, United States
New Mexico Cancer Center
🇺🇸Albuquerque, New Mexico, United States
Prohealth Associates
🇺🇸Lake Success, New York, United States
Carolinas Hematology/Oncology
🇺🇸Charlotte, North Carolina, United States
Medical Oncology Associates
🇺🇸Spokane, Washington, United States
Stony Brook University
🇺🇸Stony Brook, New York, United States
Moses Cone Medical System
🇺🇸Greensboro, North Carolina, United States
Mercy Physicians of Oklahoma
🇺🇸Oklahoma City, Oklahoma, United States
Scott & White Healthcare
🇺🇸Temple, Texas, United States
Peninsula Cancer Institute
🇺🇸Newport News, Virginia, United States
Northwest Medical Specialties
🇺🇸Tacoma, Washington, United States
Univ. Colorado at Denver
🇺🇸Aurora, Colorado, United States
Cancer Center of Kansas
🇺🇸Wichita, Kansas, United States
Florida Oncology Associates
🇺🇸Jacksonville, Florida, United States
H. Lee Moffitt Cancer Center
🇺🇸Tampa, Florida, United States
Peachtree Hematology Oncology
🇺🇸Atlanta, Georgia, United States
Cancer Care Associates
🇺🇸Tulsa, Oklahoma, United States
Southbay Oncology Hematology Partners
🇺🇸Campbell, California, United States
St. Joseph Hospital
🇺🇸Orange, California, United States
Memorial Miller Hospital
🇺🇸Long Beach, California, United States
Indiana University
🇺🇸Indianapolis, Indiana, United States
Community Hospitals of Indiana
🇺🇸Indianapolis, Indiana, United States
Penn. State Univ.
🇺🇸Hershey, Pennsylvania, United States
Pinnacle Health
🇺🇸Harrisburg, Pennsylvania, United States
Stronach Regional Cancer Centre at Southlake
🇨🇦Newmarket, Ontario, Canada
Hematology Oncology Associates
🇺🇸Port St. Lucie, Florida, United States
Michigan State University
🇺🇸East Lansing, Michigan, United States
Connecticut Oncology & Hematology
🇺🇸Torrington, Connecticut, United States
Northern Utah Associates
🇺🇸Ogden, Utah, United States
The Jones Clinic
🇺🇸Germantown, Tennessee, United States
Grand River Regional Cancer Centre
🇨🇦Kitchener, Ontario, Canada
The Ottawa Hospital Cancer Centre
🇨🇦Ottawa, Ontario, Canada
Kaiser Northwest
🇺🇸Portland, Oregon, United States
The West Clinic
🇺🇸Memphis, Tennessee, United States
Sunnybrook Health Services Centre
🇨🇦Toronto, Ontario, Canada
McGill University
🇨🇦Montreal, Quebec, Canada