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dose finding study of irinotecan for UGT1A1 homozygnous group

dose finding study of irinotecan for UGT1A1 homozygnous group - dose finding study of irinotecan for UGT1A1 homozygnous group

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000002353
Enrollment
12
Registered
2009-10-01
Start date
2009-10-01
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

gastric cancer,colorectal cancer,lung cancer,ovarian cancer,cervical cancer and brest cancer

Interventions

Administraion of irinotecan is twice for 4 weeks . Adjusted dosage is determined from 100or125 mg/sqm in the heterozygous group .

Sponsors

kobe University Hospital and Graduate School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1)Histologically confirmed cancer 2)Testing confirmed UGT1A1*28 and UGT1A1*6 polymorphisms 3)Having prior chemotherapy as standard regimens 4)No prior irinotecan containing treatment 5)Age:>=20 years old at wiritten informed concent 6)PS(ECOG):0 to 1

Exclusion criteria

Exclusion criteria: 1)History of serious drug allergy 2)Active concomitant malignancy 3)Prior extensively irradiation for abdominal or bowel bone marrow 4)Symptomatic brain metastasis 5)Systemic continual use of steroids 6)Active infection 7)Persistent diarrhea (watery stool) 8)Intestinal obstraction or paralytic ileus 9)Interstitial pneumonia or pulmonary fibrosis 10)Massive pleural, pericardial effusion or asites that required drainage 11)Need to treatment with atazanavir sulfate 12)Uncontrolled diabetes mellitus 13)Heart disease deemed to unacceptable by diagnosis of cardiogram within the previous 28 days before enrollment 14)Psychological disease deemed to unacceptable for inclusion to the study 15)Pregnant or lactating women, couple wishing pregnant or no mind of prevent pregnancy 16)Other concominant medical condition deemed to inadequate for inclusion to the study

Design outcomes

Primary

MeasureTime frame
adverse events

Countries

Japan

Contacts

Public ContactHideo Tomioka

kobe University Hospital and Graduate School of Medicine Medical Oncology,Department of Medicine

tomy705@med.kobe-u.ac.jp

Outcome results

None listed

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