The primary objective of this study is to compare the efficacy of GEM plus Z-360 versus GEM plus placebo on the overall survival (OS) in subjects with metastatic Pancreatic Adenocarcinoma.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
167
Gemcitabine (1,000 mg/m\^2) will be given by 30-minute intravenous infusion on Day 1, 8, and 15 followed by a one week rest in all 28-day Cycles, while Z-360 (60, 120 or 240 mg) will be taken orally, twice daily (BID) after a meal. Dosing will continue until the patient fulfills the withdrawal criteria.
Gemcitabine (1,000 mg/m\^2) will be given by 30-minute intravenous infusion on Day 1, 8, and 15 followed by a one week rest in all 28-day Cycles, while placebo will be taken orally, twice daily (BID) after a meal. Dosing will continue until the patient fulfills the withdrawal criteria.
Zeria Investigative sites
Japan, Japan
Zeria Investigative Sites
Korea, South Korea
Zeria Investigative Sites
Dawan, Taiwan
Overall Survival
Time frame: Approximately 24 months
Progression Free Survival (PFS)
Time frame: Approximately 24 months
Time to Treatment Failure
Time frame: Approximately 24 months
Quality of Life
Time frame: Approximately 24 months
Safety parameters
Incidence of SAEs and AEs, laboratory test results, vital signs, ECG results and physical examination findings
Time frame: Approximately 24 months
Pharmacokinetics
To characterize the plasma pK of Z-360 when given in combination with GEM
Time frame: Day1
Response Rate
Time frame: Approximately 24 months
Benefit Rate
Time frame: Approximately 24 months
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