The purpose of the dose escalation phase is to evaluate the safety profile of escalating doses and dose schedules of NXP800. In the expansion phase the preliminary efficacy in subjects with ARID1a mutated ovarian clear cell and ovarian endometrioid cancers will be estimated.
Part A of the study is a dose escalation by cohort study of NXP800 administered to patients with advanced cancers. The study will identify the maximum tolerated dose (MTD) and propose dose and dose schedules for future studies. In Part B doses selected in Part A are administered to patients with platinum-resistant, ARID1a-mutated ovarian carcinoma.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
45
NXP800 is an anti-neoplastic, oral small molecule.
Honor Health
Phoenix, Arizona, United States
UC San Diego Health - Moores Cancer Center
La Jolla, California, United States
University of Colorado Cancer Center
Aurora, Colorado, United States
Yale Gynecologic Oncology
New Haven, Connecticut, United States
Florida Cancer Specialists South
Fort Myers, Florida, United States
Mount Sinai Comprehensive Cancer Center
Miami Beach, Florida, United States
Florida Cancer Specialists Research North
St. Petersburg, Florida, United States
Florida Cancer Specialists Research East
West Palm Beach, Florida, United States
University of Iowa
Iowa City, Iowa, United States
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, United States
...and 12 more locations
Part A: Number of patients with treatment related adverse events, clinical laboratory abnormalities, dose limiting toxicities
Time frame: Day 28
Part B: Estimates of disease response by RECIST v 1.1
Time frame: Baseline to 30 days post last dose of NXP800
Part B: Number of patients with treatment related adverse events, and/or clinical laboratory abnormalities.
Time frame: Baseline to 30 days post last dose of NXP800
Area under the concentration-time curve (AUC) of NXP800
Time frame: First dose through Day 29
Maximum observed concentration (Cmax) of NXP800
Time frame: First dose through Day 29
Time to peak concentration (Tmax) of NXP800
Time frame: First dose through Day 29
Half-life (T1/2) of NXP800
Time frame: First dose through Day 29
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