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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00910741
Recruitment Status : Completed
First Posted : June 1, 2009
Last Update Posted : January 9, 2014
Orient Europharma Co., Ltd.
Information provided by (Responsible Party):
NanoCarrier Co., Ltd.

Brief Summary:
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 or disease Intervention/treatment Phase
Locally Advanced and Metastatic Pancreatic Cancer Drug: Nanoplatin (NC-6004) and Gemcitabine Phase 1 Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
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
Study Start Date : May 2009
Actual Primary Completion Date : July 2013
Actual Study Completion Date : July 2013

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 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 :
  1. Overall survival [ Time Frame: 1.5 year ]

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 75 Years   (Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): 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

Responsible Party: NanoCarrier Co., Ltd. Identifier: NCT00910741     History of Changes
Other Study ID Numbers: NC-6004-002
First Posted: June 1, 2009    Key Record Dates
Last Update Posted: January 9, 2014
Last Verified: January 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