Completed

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

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What is being tested

Nanoplatin (NC-6004) and Gemcitabine

Drug
Who is being recruted

Digestive System Diseases+5

+ Digestive System Neoplasms

+ Endocrine System Diseases

From 20 to 75 Years
+6 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 1 & 2
Interventional
Study Start: May 2009
See protocol details

Summary

Principal SponsorNanoCarrier Co., Ltd.
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: May 1, 2009

Actual date on which the first participant was enrolled.

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.

Official TitlePhase I/II Study of the Combination Therapy With NC-6004 and Gemcitabine in Patients With Locally Advanced or Metastatic Pancreatic Cancer in Asian Countries
NCT00910741
Principal SponsorNanoCarrier Co., Ltd.
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

40 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 20 to 75 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Digestive System DiseasesDigestive System NeoplasmsEndocrine System DiseasesEndocrine Gland NeoplasmsNeoplasmsNeoplasms by SitePancreatic DiseasesPancreatic Neoplasms

Criteria

2 inclusion criteria required to participate
Patients with chemo-naive, advanced pancreatic cancer
Nonresectable, histologically or cytologically confirmed, locally advanced or metastatic pancreatic cancer
4 exclusion criteria prevent from participating
Pulmonary fibrosis or interstitial pneumonia
Marked pleural effusion or ascites above Grade 2
Severe drug hypersensitivity
Metastasis to the central nervous system and brain

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

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).

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 5 locations

Suspended

National Cancer Centre Singapore

Singapore, SingaporeOpen National Cancer Centre Singapore in Google Maps
Suspended

Natinal Cheng Kung University Hospital

Tainan, Taiwan
Suspended

National Taiwan University Hospital

Taipei, Taiwan
Suspended

Taipei Veteran General Hospital

Taipei, Taiwan
Completed5 Study Centers