Overview

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

Status:
Completed
Trial end date:
2013-07-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 1/Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
NanoCarrier Co., Ltd.
Collaborator:
Orient Europharma Co., Ltd.
Treatments:
Gemcitabine
Criteria
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