NCT02117258 - Z-360 Plus GEM in Subjects With Metastatic Pancreatic Adenocarcinoma | Biotech Hunter

Enrollment

167

Participants

Timeline

Start Date

April 30, 2014

Primary Completion Date

July 31, 2016

Study Completion Date

March 31, 2017

Conditions

Metastatic Pancreatic Adenocarcinoma

Interventions

DRUG

Z-360

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.

DRUG

Placebo

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.

Trial Locations (3)

Unknown

Zeria Investigative sites, Japan

Zeria Investigative Sites, Korea

Zeria Investigative Sites, Dawan