A Phase 1a/b, Multicenter, Open Label, Dose-Finding Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of the Dual DNA-PK and TOR Kinase Inhibitor, CC-115, Administered Orally to Subjects With Advanced Solid Tumors, and Hematologic Malignancies.
Minimum age limit is 18 years however subjects with Ewing's sarcoma may be 12 years or
older. Prostate cancer subjects have to be 'castration-' or 'hormone-' resistant.
Interventional
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Dose-Limiting Toxicity
Continuously for 28 days after starting treatment
Yes
Kristen Hege, MD
Study Director
Celgene Corporation
United States: Federal Government
CC-115-ST-001
NCT01353625
April 2011
April 2015
Name | Location |
---|---|
Memorial Sloan-Kettering Cancer Center | New York, New York 10021 |
Cedars-Sinai Medical Center | Los Angeles, California 90048 |
Henry Ford Health System | Detroit, Michigan 48202 |
University of California at San Francisco | San Francisco, California 94115 |
The University of Texas, MD Anderson Cancer Center | Houston, Texas 77030 |
Moffitt Cancer Center & Research Institute | Tampa, Florida 33612-9497 |
Karmanos Cancer Center | Detroit, Michigan 48201 |
NYU Clinical Cancer Center | New York, New York 10016 |
University of Michigan, Comprehensive Cancer Center | Ann Arbor, Michigan 48109 |
Mary Crowley Cancer Research Centers | Dallas, Texas 75201 |
UCLA Neuro-Oncology Program | Los Angeles, California 90095-1769 |
Sarah Cannon Research Institute (SCRI) Drug Development Unit | Nashville, Tennessee 37203 |