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
Patients will be randomized in a 1:1 ratio to imetelstat + paclitaxel (with or without
bevacizumab) versus paclitaxel (with or without bevacizumab) alone.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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)
No
Ted Shih, PharmD
Study Director
Geron Corporation
United States: Food and Drug Administration
CP14B014
NCT01256762
November 2010
December 2012
Name | Location |
---|---|
Ingalls Memorial Hospital | Harvey, Illinois 60426 |
Michigan State University | East Lansing, Michigan 48824 |
Hematology Oncology Associates | Atlantis, Florida 33462 |
Northeast Georgia Medical Center | Gainesville, Georgia 30501 |
Florida Oncology Associates | Orange Park, Florida 32073 |
Cancer Care Associates | Tulsa, Oklahoma 74136 |
Northern Utah Associates | Ogden, Utah 84403 |
Kootenai Medical Center | Coeur d'Alene, Idaho 83814 |
H. Lee Moffitt Cancer Center | Tampa, Florida 33612 |
Emory University | Atlanta, Georgia 30322 |
Cancer Care Associates | Fresno, California 93720 |
Redwood Regional Medical Group | Santa Rosa, California 95403 |
The West Clinic | Memphis, Tennessee 38120 |
Northwest Medical Specialties | Tacoma, Washington 98405 |
Peninsula Cancer Institute | Newport News, Virginia 23601 |
Indiana University | Indianapolis, Indiana 46202 |
The Jones Clinic | Germantown, Tennessee 38138 |
Cancer Center of Kansas | Wichita, Kansas 67214 |
New Mexico Cancer Center | Albuquerque, New Mexico 87109 |
Southbay Oncology Hematology Partners | Campbell, California 95008 |
Horizon Oncology Center | Lafayette, Indiana 47905 |
Northeast Georgia Cancer Care | Athens, Georgia 30607 |
Summit Cancer Care | Savannah, Georgia 31405 |
Rush University | Chicago, Illinois 60612 |
Mercy Physicians of Oklahoma | Tulsa, Oklahoma 74136 |
Clearview Cancer Center | Huntsville, Alabama 35801 |
Central Georgia Cancer Care | Macon, Georgia 31201 |
St. Joseph Hospital | Orange, California 92868 |
Connecticut Oncology & Hematology | Torrington, Connecticut 06790 |
Alta Bates Summit Medical Center | Berkeley, California 94704 |
Kaiser Northwest | Portland, Oregon 97227 |
Medical Oncology Associates | Spokane, Washington 99208 |
UC San Diego | La Jolla, California 92093 |
Memorial Miller Hospital | Long Beach, California 90806 |
Desert Regional Comprehensive Cancer Center | Palm Springs, California 92262 |
Univ. Colorado at Denver | Aurora, Colorado 80045 |
Medical Oncology Hematology | Waterbury, Connecticut 06708 |
Peachtree Hematology Oncology | Atlanta, Georgia 30318 |
Mid Illinois Hematology & Oncology | Normal, Illinois 61761 |
Cancer Treatment Centers of America | Zion, Illinois 60099 |
Community Hospitals of Indiana | Indianapolis, Indiana 46268 |
Montgomery Cancer Care | Mount Sterling, Kentucky 40353 |
Prohealth Associates | Lake Success, New York 11402 |
Stony Brook University | Stony Brook, New York 11794 |
Carolinas Hematology/Oncology | Charlotte, North Carolina 28203 |
Moses Cone Medical System | Greensboro, North Carolina 27403 |
Case Western Reserve Univ. | Cleveland, Ohio 44106 |
Pinnacle Health | Harrisburg, Pennsylvania 17110 |
Penn. State Univ. | Hershey, Pennsylvania 17033 |
Scott & White Healthcare | Temple, Texas 76508 |