Spots Global Cancer Trial Database for Study of INCB053914 in Subjects With Advanced Malignancies
The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.
Trial Identification
Brief Title: Study of INCB053914 in Subjects With Advanced Malignancies
Official Title: A Phase 1/2 Study of INCB053914 in Subjects With Advanced Malignancies
Study ID: NCT02587598
Conditions
Study Description
Brief Summary: This is an open-label, dose-escalation study of the proviral integration site of Moloney murine leukemia virus (PIM) kinase inhibitor INCB053914 in subjects with advanced malignancies. The study will be conducted in 4 parts. Part 1 (monotherapy dose escalation) will evaluate safety and determine the maximum tolerated dose of INCB053914 monotherapy and the recommended phase 2 dose(s) (a tolerated pharmacologically active dose that will be taken forward into the remaining parts of the study). Part 2 (monotherapy dose expansion) will further evaluate the safety, efficacy, pharmacokinetics (PK), and pharmacodynamics (PD) of the recommended Phase 2 dose(s). Part 3 (combination dose finding) will evaluate safety of INCB053914 in combination with select standard of care (SOC) agents and will identify the optimal INCB053914 dose in combination with conventional SOC regimens to take forward into Part 4. Part 4 (combination dose expansion) will further evaluate the safety, efficacy and pharmacokinetics of the recommended Phase 2 dose combination(s).
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
The University of Arizona Cancer Center, Tucson, Arizona, United States
UC Davis comprehensive Cancer Center, Sacramento, California, United States
UCLA Medical Hematology & Oncology, Santa Monica, California, United States
Yale University, New Haven, Connecticut, United States
Mayo Clinic Florida, Jacksonville, Florida, United States
Florida Cancer Specialists & Research Institute, Sarasota, Florida, United States
H. Lee Moffitt Cancer Center & Research Institute, Tampa, Florida, United States
Emory University-Winship Cancer Institute, Atlanta, Georgia, United States
University of Maryland, Baltimore, Maryland, United States
Dana-Farber Cancer Center, Boston, Massachusetts, United States
University of Michigan Comprehensive Cancer Center, Ann Arbor, Michigan, United States
University of Nebraska Medical Center, Omaha, Nebraska, United States
Oncology Hematology Care Clinical Trials LLC, Cincinnati, Ohio, United States
Stephenson Cancer Center, Oklahoma City, Oklahoma, United States
Tennessee Oncology, Nashville, Tennessee, United States
Vanderbilt University Medical Center, Nashville, Tennessee, United States
Texas Oncology, Austin, Texas, United States
Texas Oncology, Tyler, Texas, United States
Medical College of Wisconsin, Milwaukee, Wisconsin, United States
Contact Details
Name: Fred Zheng, M.D.
Affiliation: Incyte Corporation
Role: STUDY_DIRECTOR
Take Control of Your Skin and Body Changes Today.
Try out Spots for free, set up only takes 2 mins.
Join others from around the world:
