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

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

Status

Completed

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00910741

Enrollment

Registered

2009-06-01

Start date

2009-05-31

Completion date

2013-07-31

Last updated

2014-01-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Locally Advanced and Metastatic Pancreatic Cancer

Keywords

pancreatic cancer, Gemcitabine

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.

Interventions

DRUGNanoplatin (NC-6004) and Gemcitabine

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to 75 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Incidence of DLT and Response rate	DLT is evaluated for 3 weeks o the treatment, Response rate is evaluated at 7,13,19 and 25weeks of the treatment

Secondary

Measure	Time frame
Overall survival	1.5 year

Countries

Singapore, Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026