The purpose of this study is to evaluate the safety and clinical activity of paclitaxel plus olaparib and pembrolizumab in patients with previously treated advanced Gastric Cancer (GC).
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
19
Paclitaxel (80mg/m\^2) will be administered IV on days 1 and 8 starting with Cycle 2. Each Cycle is 21 days.
Olaparib (100mg or 300mg) will be administered orally on Days 1-21 of each Cycle. Each Cycle is 21 days.
Pembrolizumab (200mg) will be administered IV on day 1 of each Cycle. Each Cycle is 21 days.
Sidney Kimmel Comprehensive Cancer Center
Baltimore, Maryland, United States
Overall Survival (OS)
Overall survival is the time from the start of first dose of study drug to death or end of follow-up (OS will be censored on the date the subject was last known to be alive for subjects without documentation of death at the time of analysis). Estimation based on the Kaplan-Meier curve.
Time frame: Up to 27 months
Number of Participants Experiencing Grade 3 or Above Study Drug-related Adverse Events (AEs)
When calculating the incidence of AEs, each AE (as defined by NCI CTCAE v5.0) will be counted only once for a given subject. Laboratory abnormalities that were asymptomatic and not clinically significant were excluded.
Time frame: 15 months
Number of Participants Experiencing Immune-related Adverse Events (irAEs)
When calculating the incidence of AEs, each AE (as defined by NCI CTCAE v5.0) will be counted only once for a given subject. Laboratory abnormalities that were asymptomatic and not clinically significant were excluded.
Time frame: 15 months
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