This is a phase I, open-label study of D-0502 single agent and D-0502 in combination with standard dose of palbociclib to assess the safety and tolerability, identify an MTD, and/or RP2D, evaluate the PK properties and evaluate preliminary anti-tumor activities in women with advanced or metastatic ER-positive, HER2-negative breast cancer.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
200
oral tablets
standard dose of palbociclib
Local Institution
Fresno, California, United States
Local Institution
Aurora, Colorado, United States
Local Institution
New Haven, Connecticut, United States
Incidence of AEs meeting protocol defined dose-limiting toxicities (DLTs) criteria
Time frame: Approximately 2 years
Maximum observed serum concentration (Cmax)
Time frame: Cycle 1 (28 days)
Area under the serum concentration-time curve from time zero to time of last quantifiable concentration [AUC(0-T)]
Time frame: Cycle 1 (28 days)
Time of maximum observed concentration (Tmax)
Time frame: Cycle 1 (28 days)
Objective response rate (ORR)
Time frame: up to 12 months
Progression free survival (PFS)
Time frame: up to 12 months
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Local Institution
Boston, Massachusetts, United States
Local Institution
Eugene, Oregon, United States
Local Institution
Greenville, South Carolina, United States
Local Institution
Nashville, Tennessee, United States
Local Institution
Dallas, Texas, United States
Local Institution
San Antonio, Texas, United States
Local Institution
San Antonio, Texas, United States
...and 5 more locations