An Open-Label Randomized, Phase 2A, Dose-ranging Study (Part 1) of Sotatercept (ACE-011) for Chemotherapy-Induced Anemia in Subjects With Advanced or Metastatic Solid Tumors Treated With Platinum-Based Chemotherapeutic Regimens Followed by a Phase 2B/3, Double-blind, Randomized, Placebo-controlled Study (Part 2) of Sotatercept (Ace-011) for Chemotherapy-Induced Anemia in Subjects With Metastatic Non-small Cell Lung Cancer Treated With First-line Platinum-based Chemotherapeutic Regimens
Part 1: Metastatic non-small and small cell lung cancer, metastatic bladder, head and neck,
and cervical cancer: Modified to expand eligible tumor types to include advanced or
metastatic solid tumors treated with first-line platinum-based chemotherapy, excluding those
solid tumors treated with curative intent, in Part 1 of the study.
Part 2 metastatic non small cell lung cancer; Modified to confirm only metastatic NSCLC
subjects are eligible for Part 2 of the study
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Supportive Care
Hematopoietic response
Hematopoietic response in ~70% of subjects (defined as an increase in hemoglobin of > 1.0g/dL, above the study baseline for 4 consecutive weeks, in absence of red blood cell transfusion and/or Erythropoiesis-stimulating agents (ESAs).
Up to Day 43
No
Abderrahmane Laadem, MD
Study Director
Celgene Corporation
United States: Food and Drug Administration
ACE-011-NSCL-001
NCT01284348
January 2011
April 2013
Name | Location |
---|---|
University of Texas Medical Branch | Galveston, Texas 77555-1329 |
Cancer Centers of the Carolinas | Greenville, South Carolina 29605 |
Vanderbilt University Medical Center | Nashville, Tennessee 37232-2516 |
Comprehensive Blood and Cancer Center | Bakersfield, California 93309 |
Loma Linda University Cancer Institute | Loma Linda, California 92354 |
Mary Crowley Medical Research Center | Dallas, Texas 75246 |
University of California Los Angeles | Los Angeles, California 90095-6951 |
Duke University Medical Center | Durham, North Carolina 27710 |
Medical Oncology Care Associates | Orange, California 92668 |
Henry Ford Health System | Detroit, Michigan 48202 |
Dartmouth Hitchcock Medical Center | Lebanon, New Hampshire 03756 |
Lahey Clinic | Burlington, Massachusetts 01805 |
Gabrail Cancer Center | Canton, Ohio 44718 |
Cancer Care Associates Medical Group, Inc. | Torrance, California 90505 |
Allison Cancer Center | Midland, Texas 79701 |
The West Clinic | Memphis, Tennessee 38120 |
Compassionate Cancer Care Medical Group, Inc | Fountain Valley, California 92708 |
Joliet Oncology-Hematology Associates, Ltd. | Flossmoor, Illinois 60422 |
Piedmont Hematology Oncology Associates, PLLC | Winston-Salem, North Carolina |
Billings Clinic | Billings, Montana 59107-7000 |
North Valley Hematology Oncology Medical Group | Mission Hills, California 91343 |
Comprehensive Cancer Centers of Nevada (TORI) | Las Vegas, Nevada 89109 |
Ocala Oncology Center PL | Ocala, Florida 34474 |
Willamette Valley Cancer Institute and Research Center | Springfield, Oregon 97477 |
Quincy Medical Group | Quincy, Illinois 62301 |
Purchase Cancer Group | Paducah, Kentucky 42002 |
Iowa Blood & Cancer Care | Cedar Rapids, Iowa 52402 |
Texas Oncology - Bedford | Bedford, Texas 76022 |
Hematology Oncology Associates, PC | Stamford, Connecticut 06902 |
Arizona Oncology Associates, P.C., | Phoenix, Arizona 85016 |
Pacific Cancer Medical Inc. | Anaheim, California 92801 |
Saint Jude Heritage Medical Center | Fullerton, California 92835 |
Central Coast Medical Oncology Group | Santa Maria, California 93454 |
Stockton Hematology Oncology Medical Group, Inc | Stockton, California 95204 |
Saint Mary Regional Cancer Center | Grand Junction, Colorado 81501 |
Minnesota Oncology Associates, PC | Minneapolis, Minnesota 55404 |
Monter Cancer Center, North Shore LIJ Health Systems | Lake Success, New York 11042 |
University of Cincinnati Physician's Inc. | Cincinnati, Ohio 45267 |
Saint Charles Medical Center | Bend, Oregon 97701 |
Oncology & Hematology Associates of Southwest Virginia, Inc | Salem, Virginia 24073 |
Northwestern Medical Specialists, PLLC | Tacoma, Washington 98405 |