NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JRCT ID: jRCT2080220858

Registered date:14/09/2009

Basic Information

Recruitment status
Health condition(s) or Problem(s) studiedunresectable locally advanced or metastatic pancreatic cancer
Date of first enrollment14/09/2009
Target sample size30
Countries of recruitment
Study typeInterventional
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 OutcomeEfficacy, Safety
Secondary Outcome

Key inclusion & exclusion criteria

Age minimum>= 20age old
Age maximum<= 80age old
GenderBoth
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

Contact

Public contact
Name
Address clinical-trials@chugai-pharm.co.jp
Telephone
E-mail
Affiliation Chugai Pharmaceutical Co., Ltd.
Scientific contact
Name
Address clinical-trials@chugai-pharm.co.jp
Telephone
E-mail
Affiliation Chugai Pharmaceutical Co., Ltd.