The purpose of this phase 2, multiple-cohort, randomized, open-label, international study of talazoparib (a poly (ADP-ribose) polymerase (PARP) inhibitor) is to compare the efficacy and safety of talazoparib monotherapy and talazoparib plus temozolomide in women with relapsed ovarian, fallopian tube, and peritoneal cancer.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Talazoparib monotherapy 1mg/day orally
temozolomide 37.5 mg/m2 on days 1-5 of each cycle
Determine Objective Response Rate (ORR)
Time frame: Anticipated in about 44 months following first patient enrolled
Progression-free survival (PFS)
Time frame: Anticipated in about 44 months following first patient enrolled
PFS at 24 weeks
Time frame: Anticipated in about 44 months following first patient enrolled
Gynecologic Cancer Intergroup (GCIG) CA125 response rate
Time frame: Anticipated in about 44 months following first patient enrolled
Clinical benefit rate at 24 weeks
Time frame: Anticipated in about 44 months following first patient enrolled
Duration of response (DOR)
Time frame: Anticipated in about 44 months following first patient enrolled
Time to response
Time frame: Anticipated in about 44 months following first patient enrolled
Overall survival
Time frame: Anticipated in about 44 months following first patient enrolled
Safety as assessed by percentage of patients with any Adverse Event (AE), AE leading to Study Drug Discontinuation, AE leading to death, SAE, AE related to study drug, SAE related to study drug.
Time frame: Anticipated in about 44 months following first patient enrolled
Pharmacokinetics of talazoparib as assessed by trough plasma concentrations
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Time frame: Anticipated in about 44 months following first patient enrolled