Phase 2, Multi-center, Open-label Trial to Evaluate Efficacy and Safety of GM-CT-01 in Combination With 5-FU as First Line Chemotherapy in Patients With Advanced Biliary Cancer
Determine the overall response rate (ORR) defined as complete response (CR)rate plus partial
response (PR) rate using Response Evaluation Criteria in Solid Tumors (RECIST), as well as
the stable disease (SD) rate in subjects with unresectable, locally advanced or metastatic
cholangiocarcinoma or other biliary tract tumors treated with GM-CT-01 plus 5-Fluorouracil
(DAVFU) at doses of 280 mg/m2 and 600 mg/m2, respectively, during cycles of 4 consecutive
days of treatment followed by a 24-day follow-up period.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Objective response rate (ORR) defined as complete response (CR) rate plus partial response (PR) rate using Response Evaluation Criteria in Solid Tumors (RECIST)
A minimum of 18 subjects who meet the response evaluation criteria (per protocol population) will be enrolled in Stage 1. This require 2nd CT evaluation of tumor after minimum 2 cycles of treatments. CR, PR, SD and progressive disease (PD) as defined by RECIST criteria.
When 18 valuable patients have completed 2nd CT
United States: Food and Drug Administration
|Boston Medical Center||Boston, Massachusetts 02118|
|Barrett Cancer Center||Cincinnati, Ohio 45267-0502|
|University of Michigan, Comprehensive Cancer Center||Ann Arbor, Michigan 48109|