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

Status

Recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000005363

Enrollment

Registered

2011-04-01

Start date

2011-03-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

biliary tract cancer or pancreatic cancer with liver dysfunction

Interventions

Patients are classified into three groups

mild, moderate or severe liver dysfunction. Determination of the optimal dose for each group. 1) Mild dysfunction

Group1 Total bilirubin =&lt

ULN, AST/ALT&gt

ULN Group2 Total bilirubin &gt

1.0x to 1.5x ULN, AST/ALT Any 2) Level1

1000mg/m2 3) blood samples (8 points) are collected bofore and after the first administration of gemcitabine to consider its pharmacokinetics 1) Moderate dysfunction

Total bilirubin &gt

1.5x to 3.0x ULN, AST/ALT Any 2) Level1

800mg/m2, Level2

1000mg/m2 3) blood samples (8 points) are collected bofore and after the first administration of gemcitabine to consider its pharmacokinetics 1) Severe dysfunction

3.0x to 10x ULN, AST/ALT Any 2) Level1

1000mg/m2 Level-1

650mg/m2 3) blood samples (8 points) are collected bofore and after the first administration of gemcitabine to consider its pharmacokinetics

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Cytologically or histologically diagnosed biliary tract or pancreatic cancer 2) planned to receive gemcitabine monotherapy (including adjuvant chemotherapy) 3) Patients with liver dysfunction 4) Patients over 20 years old at the time of obtaining informed consent 5) Performance status 0-2 in classification of mild or moderate liver dysfunction Performance status 0,1 in classification of severe liver dysfunction 6) Patients with adequate bone marrow functions neutrophil count >= 1,500/uL platelet count >= 10,0000/uL hemoglobin >= 9.0g/dL 7) Patients received a sufficient explanation for this study and agreed 8) does not ask whether the patients have the mesurable lesion 9) If the patient underwent biliary drainage,the patient met the above criteria can be incorporated

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Performance status, hematologic toxicity, and non-hematological toxicity during the first course of gemcitabine	—

Secondary

Measure	Time frame
Pharmacokinetics	—

Countries

Japan

Contacts

Public ContactTakashi Shibata

Nagoya university hospital Department of Clinical Oncology and Chemotherapy

tshibata@med.nagoya-u.ac.jp

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026