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.
Investigators
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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