JRCT ID: jRCT2080220858
Registered date:14/09/2009
Basic Information
Recruitment status | |
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Health condition(s) or Problem(s) studied | unresectable locally advanced or metastatic pancreatic cancer |
Date of first enrollment | 14/09/2009 |
Target sample size | 30 |
Countries of recruitment | |
Study type | Interventional |
Intervention(s) | investigational material(s) Generic name etc : MRA INN of investigational material : Therapeutic category code : 429 Other antitumor agents Dosage and Administration for Investigational material : 8 mg/kg, every 2 weeks |
Outcome(s)
Primary Outcome | Efficacy, Safety |
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Secondary Outcome |
Key inclusion & exclusion criteria
Age minimum | >= 20age old |
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Age maximum | <= 80age old |
Gender | Both |
Include criteria | -Histologically or cytologically confirmed pancreatic cancer with unresectable locally advanced or metastatic disease -No prior chemotherapy or radiotherapy for pancreatic cancer, other than resection -C-reactive protein(CRP) >= 2.0 mg/dL -At least one measurable target lesion by RECIST ver 1.0 -ECOG performance status of 0 - 2 |
Exclude criteria | -Patients who have an infection that requires systemic administration of drugs such as antibiotics, antiviral drugs or antifungal drugs. -Patients has non-neoplastic disease requiring systemic administration of corticosteroids. -Women who are pregnant or nursing mothers. -The patient have a pulmonary disorder such as idiopathic pulmonary fibrosis or interstitial pneumonia or has a history of these. -Patients who undergone biliary stent insertion or cholangiojejunostomy. |
Related Information
Primary Sponsor | Chugai Pharmaceutical Co., Ltd. |
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Secondary Sponsor | |
Source(s) of Monetary Support | |
Secondary ID(s) | JapicCTI-090889 |
Contact
Public contact | |
Name | |
Address | clinical-trials@chugai-pharm.co.jp |
Telephone | |
Affiliation | Chugai Pharmaceutical Co., Ltd. |
Scientific contact | |
Name | |
Address | clinical-trials@chugai-pharm.co.jp |
Telephone | |
Affiliation | Chugai Pharmaceutical Co., Ltd. |