CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 25 enrolled
Drug / intervention
CPT-11, Raltegravir (Isentress®), Midazolamdrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00808184
NCT00808184Phase 4Completed
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Pharmacokinetic Study of CPT-11, Raltegravir and Midazolam With Characterisation of UGT1A1 Genotype

National University Hospital, Singapore·interventional·Posted Dec 15, 2008·Updated Nov 1, 2012

In Brief

A Phase 4 clinical trial evaluating CPT-11, Raltegravir (Isentress®), Midazolam for Solid Tumor. Completed, enrolled 25 participants across 2 sites.

Detailed Summary

The objectives of this study are: To correlate pharmacokinetic parameters of raltegravir and midazolam with irinotecan (CPT-11) and its metabolite SN-38. To correlate the genotype of UGT1A1 of patients receiving CPT-11 chemotherapy with irinotecan and raltegravir pharmacokinetic parameters. To model pharmacokinetic and pharmacodynamic behaviour of CPT-11 in the study population.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSolid Tumor
CountriesSingapore
Collaborators--

Timeline

Phase 4CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedDec 15, 2008
Enrollment StartApr 1, 2010
Primary CompletionFeb 1, 2012
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 17.5 years ago

Interventions

CPT-11, Raltegravir (Isentress®), Midazolamdrug