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Clinical Trials/JPRN-UMIN000005363
JPRN-UMIN000005363
Recruiting
Phase 1

Clinical dose-finding and pharmacokinetic study of gemcitabine in patients with biliary tract or pancreatic cancer with liver dysfunction - Clinical dose-finding and pharmacokinetic study of gemcitabine in patients with biliary tract or pancreatic cancer with liver dysfunction

agoya university hospital0 sites30 target enrollmentApril 1, 2011

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
biliary tract cancer or pancreatic cancer with liver dysfunction
Sponsor
agoya university hospital
Enrollment
30
Status
Recruiting
Last Updated
2 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
April 1, 2011
End Date
March 31, 2015
Last Updated
2 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
agoya university hospital

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • 1\) Patients have received in the past gemcitabine hydrochloride monotherapy 2\) Total bilirubin \>10x ULN 3\) Serum creatinin \>1\.5x ULN 4\) Performance status 2 in classification of severe liver dysfunction 5\) patients with interstitial pneumonia or pulmonary fibrosis on chest X\-ray and having clinical symptoms 6\) Patients with infections requiring treatment 7\) Patients with uncontrolled diabetes despite the enforcement of appropriate drug therapy (including insulin) 8\) it is clear that patients with constitutional jaundice 9\) HBc antibody, HCV antibody, HIV antibody or syphilis positive 10\) In addition, patients were judged inappropriate to participate in the clinical trial

Outcomes

Primary Outcomes

Not specified

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