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CompletedNCT00910741Updated Jan 9, 2014

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

A Phase 1/2 interventional study of Nanoplatin (NC-6004) and Gemcitabine in Locally Advanced and Metastatic Pancreatic Cancer, sponsored by NanoCarrier Co., Ltd.. Completed at 5 sites in 2 countries. Open to participants aged 20 Years to 75 Years. Per ClinicalTrials.gov, last updated 2014-01-09.

Sponsored by NanoCarrier Co., Ltd. · Phase 1/2, Interventional, and Treatment

Phase
Phase 1/2
Study type
Interventional
Enrollment
40
Allocation
Not applicable
Ages
20 Years to 75 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Locally Advanced and Metastatic Pancreatic Cancer

Keywords

  • pancreatic cancer
  • Gemcitabine
03

In context

Pancreatic Neoplasms

3,235 studies on the registry are indexed under Pancreatic Neoplasms; 898 are open to participants now.

This study's enrollment of 40 is below the median of 46 across 2,424 interventional studies indexed under Pancreatic Neoplasms.

Browse Pancreatic Neoplasms studies →

Lead sponsor

NanoCarrier Co., Ltd. is the lead sponsor of 6 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 75 Years
Sexes eligible
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

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
05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
40 participants (actual)

Study arms

  • 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

Interventions

  • DrugNanoplatin (NC-6004) and Gemcitabine
06

What researchers measure

Primary outcomes

  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 outcomes

  1. Overall survival

    Time frame: 1.5 year

07

Study locations

5 sites
  • 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
08

References and documents

Publications

  • Uchino H, Matsumura Y, Negishi T, Koizumi F, Hayashi T, Honda T, Nishiyama N, Kataoka K, Naito S, Kakizoe T. Cisplatin-incorporating polymeric micelles (NC-6004) can reduce nephrotoxicity and neurotoxicity of cisplatin in rats. Br J Cancer. 2005 Sep 19;93(6):678-87. doi: 10.1038/sj.bjc.6602772. PubMed 16222314 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 9, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00910741
Lead sponsor
NanoCarrier Co., Ltd.
Collaborators
Orient Europharma Co., Ltd.
Responsible party
Sponsor
First posted
Jun 1, 2009
Start date
May 2009
Primary completion
Jul 2013
Completion
Jul 2013
Last update
Jan 9, 2014

Study contacts

Wu-Chou Su, MD
principal investigator · National Cheng-Kung University Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2014. You cannot join it, but the record below documents what was studied.

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