15
Participants
Start Date
September 25, 2019
Primary Completion Date
April 5, 2022
Study Completion Date
April 5, 2022
INCB001158
Phase 1: INCB001158 administered orally twice daily at the protocol-defined starting dose, with dose escalation/de-escalation based on protocol-defined toxicity criteria to determine the maximum tolerated dose. INCB001158 is administered in combination with daratumumab SC. Phase 2: INCB001158 administered orally at the recommended dose from Phase 1 either as a monotherapy or in combination with daratumumab SC.
Daratumumab SC
Daratumumab 1800 mg co-formulated with rHuPH20 (2000 U/mL) and administered subcutaneously once weekly for Cycles 1 and 2, once every 2 weeks for Cycles 3 to 6, and then once every 4 weeks. Daratumumab will be administered either as monotherapy or in combination with INCB001158.
New York Oncology Hematology, Albany
Charite - Universit�Tsmedizin Berlin, Berlin
Virginia Cancer Specialists-Fairfax, Fairfax
University of Virginia, Charlottesville
Lineberger Comprehensive Cancer Center At University of North Carolina Chapel Hill, Chapel Hill
Hospital Universitario Ramon Y Cajal, Madrid
Fundacion Jimenez Diaz University Hospital, Madrid
Hospital Universitario 12 de Octubre, Madrid
Clinica Universidad de Navarra (Cun), Pamplona
Southern Cancer Center, Daphne
Hospital Clinico Universitario de Salamanca, Salamanca
Hospital Universitario Marques de Valdecilla, Santander
Oncology Hematology Care, Inc, Cincinnati
Hospital Universitario Doctor Peset, Valencia
Hospital Universitario Y Politcnico de La Fe, Valencia
Universitatsklinikum Munster, Münster
Universitatsmedizin Der Johannes Gutenberg-Universitat Mainz Iii, Mainz
University of Heidelberg, Heidelberg
Texas Oncology - Tyler, Tyler
Texas Oncology - Fort Worth South Henderson, Fort Worth
Texas Oncology San Antonio, San Antonio
Texas Oncology-Austin Midtown, Austin
Rocky Mountain Cancer Centers, Denver
Arizona Oncology Associates (Wilmot), Tucson
Comprehensive Cancer Centers of Nevada - Twain, Las Vegas
Dana Farber Cancer Institute, Boston
Hospital General Universitari Vall D Hebron, Barcelona
Hospital Clinic I Provincial, Barcelona
Ico Institut Catala D Oncologia, Barcelona
Lead Sponsor
Incyte Corporation
INDUSTRY