Trial Information
Phase I/II Study of the Combination Therapy With NC-6004 and Gemcitabine in Patients With Locally Advanced or Metastatic Pancreatic Cancer in Asian Countries
Inclusion Criteria:
- Patients with chemo-naive, advanced pancreatic cancer
- Nonresectable, histologically or cytologically confirmed, locally advanced or
metastatic pancreatic cancer
Exclusion Criteria:
- Pulmonary fibrosis or interstitial pneumonia
- Marked pleural effusion or ascites above Grade 2
- Severe drug hypersensitivity
- Metastasis to the central nervous system and brain
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Incidence of DLT and Response rate
Safety Issue:
Yes
Principal Investigator
Wu-Chou Su, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
National Cheng-Kung University Hospital
Authority:
Taiwan: Department of Health
Study ID:
NC-6004-002
NCT ID:
NCT00910741
Start Date:
May 2009
Completion Date:
June 2013
Related Keywords:
- Locally Advanced Pancreatic Cancer
- Metastatic Pancreatic Cancer
- pancreatic cancer
- Gemcitabine
- Pancreatic Neoplasms