NC-6004(Nanoplatin) and Gemcitabine to Treat Pancreatic Cancer in Asia
Phase 1
Completed
- Conditions
- Locally Advanced and Metastatic Pancreatic Cancer
- Interventions
- Drug: Nanoplatin (NC-6004) and Gemcitabine
- Registration Number
- NCT00910741
- Lead Sponsor
- NanoCarrier Co., Ltd.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 40
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Nanoplatin Nanoplatin (NC-6004) and Gemcitabine 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).
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Overall survival 1.5 year
Trial Locations
- Locations (5)
National Cancer Centre Singapore
🇸🇬Singapore 169610, Singapore
Natinal Cheng Kung University Hospital
🇨🇳Tainan, Taiwan
National Taiwan University Hospital
🇨🇳Taipei, Taiwan
Taipei Veteran General Hospital
🇨🇳Taipei, Taiwan
Chang Gung Memorial Hospital
🇨🇳Taoyuan, Taiwan