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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-05-31

Study Completion Date

2013-07-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Locally Advanced and Metastatic Pancreatic Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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).

Group Type EXPERIMENTAL

Nanoplatin (NC-6004) and Gemcitabine

Intervention Type DRUG

Interventions

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Nanoplatin (NC-6004) and Gemcitabine

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

20 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No