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

This study has been completed.
Orient Europharma Co., Ltd.
Information provided by (Responsible Party):
NanoCarrier Co., Ltd. Identifier:
First received: May 29, 2009
Last updated: January 8, 2014
Last verified: January 2014
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.

Condition Intervention Phase
Locally Advanced and Metastatic Pancreatic Cancer Drug: Nanoplatin (NC-6004) and Gemcitabine Phase 1 Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

Further study details as provided by NanoCarrier Co., Ltd.:

Primary Outcome Measures:
  • Incidence of DLT and Response rate [ Time Frame: DLT is evaluated for 3 weeks o the treatment, Response rate is evaluated at 7,13,19 and 25weeks of the treatment ]

Secondary Outcome Measures:
  • Overall survival [ Time Frame: 1.5 year ]

Enrollment: 40
Study Start Date: May 2009
Study Completion Date: July 2013
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Nanoplatin

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).

Drug: Nanoplatin (NC-6004) and Gemcitabine


Ages Eligible for Study:   20 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00910741

National Cancer Centre Singapore
Singapore 169610, Singapore
Natinal Cheng Kung University Hospital
Tainan, Taiwan
National Taiwan University Hospital
Taipei, Taiwan
Taipei Veteran General Hospital
Taipei, Taiwan
Chang Gung Memorial Hospital
Taoyuan, Taiwan
Sponsors and Collaborators
NanoCarrier Co., Ltd.
Orient Europharma Co., Ltd.
Principal Investigator: Wu-Chou Su, MD National Cheng-Kung University Hospital
  More Information

Responsible Party: NanoCarrier Co., Ltd. Identifier: NCT00910741     History of Changes
Other Study ID Numbers: NC-6004-002
Study First Received: May 29, 2009
Last Updated: January 8, 2014

Keywords provided by NanoCarrier Co., Ltd.:
pancreatic cancer

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs processed this record on September 20, 2017