Open label, multi-centre, Phase Ia/b adaptive design study with an initial 2-stage Dose Escalation Phase followed by a Dose Expansion Phase.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
180
PARP1 selective inhibitor
UC Davis Medical Centre
Sacramento, California, United States
Number of patients demonstrating dose limiting toxicities and SAEs
Number of patients demonstrating dose limiting toxicities and SAEs
Time frame: Through study completion, an average of 1 year
Number of patients exhibiting reduction in tumor size.
Objective Response Rate (ORR)
Time frame: Through study completion, an average of 1 year
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