An investigational study to determine the safety/tolerability, and efficacy of a notch signaling pathway inhibitor in patients with metastatic or locally advanced breast cancer and other advanced solid tumors.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
103
Dose escalating beginning with rising dose levels of 300, 450, and 600 mg/day in a continuous dosing schedule.
Dose 450 mg capsules daily for 28 day cycles.
Dose escalating in a repeating intermittent dosing schedule of 3 days on and 4 days off at rising dose levels of 450, 600, 800, 1000, 1200, and 1400 mg/day.
Safety and tolerability; MTD will be established
Time frame: Day 1 to Day 28
Overall tumor/disease response will be evaluated using RECIST criteria, radiographic and clinical evaluations
Time frame: radigraphic evaluation = every 56 days
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Dose escalating in a repeating intermittent dosing schedule of 1 day on/6 days off at rising dose levels of 600, 900, 1200, 1500, 1800, 2400, 3200 mg/day once weekly and then increase at 33% increments.
Dose 350 mg capsules daily intermittent 3 days on/4 days off dosing. THIS DOSING SCHEDULE IS NO LONGER UNDER INVESTIGATION