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

NanoCarrier Co., Ltd.40 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Locally Advanced and Metastatic Pancreatic Cancer

Interventions

Nanoplatin (NC-6004) and GemcitabineDRUG

Eligibility

Sex: ALLMin age: 20 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (5)

National Cancer Centre Singapore

Singapore, Singapore

Natinal Cheng Kung University Hospital

Tainan, Taiwan

National Taiwan University Hospital

Taipei, Taiwan

Taipei Veteran General Hospital

Taipei, Taiwan

Outcomes

Primary Outcomes

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

Overall survival

Time frame: 1.5 year

Data from ClinicalTrials.gov

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