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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00910741
First Posted: June 1, 2009
Last Update Posted: January 9, 2014
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.
Collaborator:
Orient Europharma Co., Ltd.
Information provided by (Responsible Party):
NanoCarrier Co., Ltd.
  Purpose
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

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   20 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00910741


Locations
Singapore
National Cancer Centre Singapore
Singapore 169610, Singapore
Taiwan
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.
Investigators
Principal Investigator: Wu-Chou Su, MD National Cheng-Kung University Hospital
  More Information

Publications:
Responsible Party: NanoCarrier Co., Ltd.
ClinicalTrials.gov Identifier: NCT00910741     History of Changes
Other Study ID Numbers: NC-6004-002
First Submitted: May 29, 2009
First Posted: June 1, 2009
Last Update Posted: January 9, 2014
Last Verified: January 2014

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

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