Trial | NCT00910741  Report issue

Title

NC-6004(Nanoplatin) and Gemcitabine to Treat Pancreatic Cancer in Asia
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

    Phase 1/Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    40
The purpose of this study is to determine the recommended dose of NC-6004 according to the dose-limiting toxicity (DLT) in combination with Gemcitabine, and to assess the efficacy, safety and tolerability.
Study Started
May 31
2009
Primary Completion
Jul 31
2013
Study Completion
Jul 31
2013
Last Update
Jan 09
2014
Estimate

Drug Nanoplatin (NC-6004) and Gemcitabine

Nanoplatin Experimental

Nanoplatin (NC-6004) had to be administered once every 3 weeks, on Day 1, Day 22 and Day 43 etc. Gemcitabine had to be administered to every patient 2 times on Day 1 and Day 8 every 3 weeks after the infusion of Nanoplatin (NC-6004).

Criteria 

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
No Results Posted