Phase 1 A: First-in-human phase 1 study to determine safety of NP-G2-044 when given orally on a daily X 28 days followed by a 14 day rest period.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
23
capsule
HonorHealth Research Institute
Scottsdale, Arizona, United States
City of Hope National Medical Center
Duarte, California, United States
Memorial Sloan Kettering Hospital
New York, New York, United States
Establish the safe recommended phase 2 dose
Treatment related adverse events assessed by CTCAE V4.03
Time frame: 24 months
Identify and characterize preliminary anti tumor activity
Anti tumor activity assessed using RECIST 1.1
Time frame: 24 months
Characterize the pharmacokinetics of NP-G2-044
Drug exposure assessed by area under the curve (AUC)
Time frame: 24 months
Tmax
Time to peak plasma concentration
Time frame: 24 months
Cmax
Peak plasma concentration
Time frame: 24 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.