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

Locally Advanced and Metastatic Pancreatic Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00910741
• Other study ID #: NC-6004-002
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: May 29, 2009
• Last updated: January 8, 2014
• Start date: May 2009
• Est. completion date: July 2013

Study information

• Verified date: January 2014
• Source: Nanocarrier Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: July 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 75 Years

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Locally Advanced and Metastatic Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

Drug:
• Nanoplatin (NC-6004) and Gemcitabine

Locations

Country	Name	City	State
Singapore	National Cancer Centre Singapore	Singapore 169610
Taiwan	Natinal Cheng Kung University Hospital	Tainan
Taiwan	National Taiwan University Hospital	Taipei
Taiwan	Taipei Veteran General Hospital	Taipei
Taiwan	Chang Gung Memorial Hospital	Taoyuan

Sponsors (2)

Lead Sponsor	Collaborator
Nanocarrier Co., Ltd.	Orient Europharma Co., Ltd.

Countries where clinical trial is conducted

Singapore,  Taiwan, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	Overall survival		1.5 year	Yes