76
Participants
Start Date
May 1, 2012
Primary Completion Date
December 11, 2014
Study Completion Date
December 11, 2014
CC-223, erlotinib
"Dose escalation: Combination doses start with 15 mg CC-223 and 100 mg erlotinib, or 15 mg CC-223 and 150 mg erlotonib, administered in 28-day cycles. Combination dose levels increase sequentially using predefined regimens until non-tolerated dose levels are established and a maximum tolerated dose combination has been identified for further study.~Dose expansion: The maximum tolerated doses are evaluated further for evidence of preliminary efficacy"
CC-223, oral azacitidine
"Dose escalation: Combination doses start with 15 mg CC-223 and 200 mg oral azacitidine, administered in 28-day cycle. Combination dose levels increase sequentially using predefined regimens until non-tolerated dose levels are established and a maximum tolerated dose combination has been identified for further study.~Dose expansion: The maximum tolerated doses are evaluated further for evidence of preliminary efficacy"
CC-223, oral azacitidine
"Dose escalation: Sequential dosing starts with 200 mg of oral azacitidine administered on Days 1 through 7 of each 28-day cycle, followed by daily dose level of 15 mg CC-223 on Days 8 through 28. Combination dose levels increase sequentially using predefined regimens until non-tolerated dose levels are established and a maximum tolerated dose combination has been identified for further study.~Dose expansion: The maximum tolerated doses are evaluated further for evidence of preliminary efficacy"
University of California, San Francisco, San Francisco
NYU School of Medicine, New York
Cancer Center of the Carolinas, Greenville
Hospital Virgen del Rocio Servicio de Hematologia, Seville
Mary Crowley Cancer Research Centers - Medical City, Dallas
The University of Texas MD Anderson Cancer Center, Houston
Cedars Sinai Medical Center, Inflammatory Bowel Disease Center, Los Angeles
Henry-Joyce Cancer Clinic, Nashville
Vall d´Hebron University Hospital, Barcelona
Lead Sponsor
Celgene
INDUSTRY