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

NanoCarrier

Status and phase: Completed; Phase 2; Phase 1

Conditions: Locally Advanced and Metastatic Pancreatic Cancer

Treatments: Drug: Nanoplatin (NC-6004) and Gemcitabine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00910741

NC-6004-002

Details and patient eligibility

About

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.

Enrollment: 40 patients

Sex: All

Ages: 20 to 75 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

Nanoplatin

Experimental group

Description:

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).

Treatment:

Drug: Nanoplatin (NC-6004) and Gemcitabine