NC-6004(Nanoplatin) and Gemcitabine to Treat Pancreatic Cancer in Asia
Phase I/II Study of the Combination Therapy With NC-6004 and Gemcitabine in Patients With Locally Advanced or Metastatic Pancreatic Cancer in Asian Countries
1 other identifier
interventional
40
2 countries
5
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started May 2009
Longer than P75 for phase_1
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2009
CompletedFirst Submitted
Initial submission to the registry
May 29, 2009
CompletedFirst Posted
Study publicly available on registry
June 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2013
CompletedJanuary 9, 2014
January 1, 2014
4.2 years
May 29, 2009
January 8, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Overall survival
1.5 year
Study Arms (1)
Nanoplatin
EXPERIMENTALNanoplatin (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).
Interventions
Eligibility Criteria
You may qualify if:
- Patients with chemo-naive, advanced pancreatic cancer
- Nonresectable, histologically or cytologically confirmed, locally advanced or metastatic pancreatic cancer
You may not qualify if:
- Pulmonary fibrosis or interstitial pneumonia
- Marked pleural effusion or ascites above Grade 2
- Severe drug hypersensitivity
- Metastasis to the central nervous system and brain
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- NanoCarrier Co., Ltd.lead
- Orient Europharma Co., Ltd.collaborator
Study Sites (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
Chang Gung Memorial Hospital
Taoyuan District, Taiwan
Related Publications (1)
Uchino H, Matsumura Y, Negishi T, Koizumi F, Hayashi T, Honda T, Nishiyama N, Kataoka K, Naito S, Kakizoe T. Cisplatin-incorporating polymeric micelles (NC-6004) can reduce nephrotoxicity and neurotoxicity of cisplatin in rats. Br J Cancer. 2005 Sep 19;93(6):678-87. doi: 10.1038/sj.bjc.6602772.
PMID: 16222314BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Wu-Chou Su, MD
National Cheng-Kung University Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 29, 2009
First Posted
June 1, 2009
Study Start
May 1, 2009
Primary Completion
July 1, 2013
Study Completion
July 1, 2013
Last Updated
January 9, 2014
Record last verified: 2014-01