NC-6004(Nanoplatin) and Gemcitabine to Treat Pancreatic Cancer in Asia
This study is currently recruiting participants.
Verified May 2009 by Nanocarrier Co., Ltd.
Sponsor:
Nanocarrier Co., Ltd.
Collaborator:
Orient Europharma Co., Ltd.
Information provided by:
Nanocarrier Co., Ltd.
ClinicalTrials.gov Identifier:
NCT00910741
First received: May 29, 2009
Last updated: May 31, 2009
Last verified: May 2009
| Tracking Information | |||||
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| First Received Date ICMJE | May 29, 2009 | ||||
| Last Updated Date | May 31, 2009 | ||||
| Start Date ICMJE | May 2009 | ||||
| Estimated Primary Completion Date | November 2011 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Incidence of DLT and Response rate [ Designated as safety issue: Yes ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00910741 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
Overall survival [ Time Frame: 1.5 year ] [ Designated as safety issue: Yes ] | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | NC-6004(Nanoplatin) and Gemcitabine to Treat Pancreatic Cancer in Asia | ||||
| Official Title ICMJE | 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 | ||||
| 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. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 1 Phase 2 |
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| Study Design ICMJE | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE |
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| Intervention ICMJE | Drug: Nanoplatin (NC-6004) and Gemcitabine | ||||
| Study Arm (s) | Experimental: Nanoplatin
Intervention: Drug: Nanoplatin (NC-6004) and Gemcitabine |
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| Publications * | 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. | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 38 | ||||
| Estimated Completion Date | June 2013 | ||||
| Estimated Primary Completion Date | November 2011 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 20 Years to 75 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | Taiwan | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00910741 | ||||
| Other Study ID Numbers ICMJE | NC-6004-002 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | H Hanada/CBO, Business Development | ||||
| Study Sponsor ICMJE | Nanocarrier Co., Ltd. | ||||
| Collaborators ICMJE | Orient Europharma Co., Ltd. | ||||
| Investigators ICMJE |
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| Information Provided By | Nanocarrier Co., Ltd. | ||||
| Verification Date | May 2009 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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