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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


Phase 1/Phase 2
20 Years
75 Years
Open (Enrolling)
Both
Locally Advanced Pancreatic Cancer, Metastatic Pancreatic Cancer

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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

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