NCT02278458 - Combination of Icotinib and Gemcitabine as First-line Treatment in Pancreatic Cancer | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

October 31, 2014

Primary Completion Date

January 31, 2016

Study Completion Date

October 31, 2016

Conditions

Pancreatic Cancer

Interventions

DRUG

icotinib

Three dose levels of icotinib are designed to be evaluated, 125 mg three times per day, 250 mg three times per day, and 375 mg three times per day. Dose escalations are based on predefined dose escalation decision rules. The Maximum Administered Dose (MAD) was reached at the dose level when at least 30% patients developed a dose limited toxicity.

DRUG

Gemcitabine

Gemcitabine: 1000 mg/m2 on Days 1, 8, and 15 of a 28 day cycle by IV administration every 4 weeks.

Trial Locations (3)

150081

Cancer Hospital of Harbin Medical University, Harbin

Bethune First Hospital of Jilin University, Changchun

First Affiliated Hospital of China Medical University, Shenyang