Clinical trial · Interventional
Pharmacokinetic Study of CPT-11, Raltegravir and Midazolam With Characterisation of UGT1A1 Genotype
NCT00808184CI-TRIAL-00008405completedPhase 4ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Solid Tumor | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CPT-11, Raltegravir (Isentress®), Midazolam | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- ACTIVE_COMPARATOR
- label
- CPT-11
- interventionNames
- Drug: CPT-11, Raltegravir (Isentress®), Midazolam
Primary outcomes (1)
- measure
- Correlate pharmacokinetic parameters of raltegravir and midazolam with irinotecan (CPT-11) and its metabolite SN-38
- timeFrame
- 1 year
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 21 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically or cytologically proven solid tumour for which CPT-11 given by the Folfiri regimen is indicated and prescribed by the attending physician. * Age above 21 years. * Measurable or evaluable disease * Karnofsky performance status \> 70% * Life expectancy \> 3 months * WBC \> 3.0 x 103/?l; ANC \> 1500/?l * Hemoglobin \> 9.0 g/dl * Platelets \> 100000/?l * Creatinine \< 1.5 x ULN or calculated creatinine clearance \> 40 ml/min * Total bilirubin \< 1.5 x ULN * SGOT, SGPT \< 5 x ULN unless due to disease Exclusion Criteria: * Biologic therapy or chemotherapy within 4 weeks. (Six weeks for prior nitrosoureas or mitomycin C). * Radiation therapy within 4 weeks if \> 25% of bone marrow was irradiated. * Have not received any medications that are known to be metabolised by UGT1A1 within 30 days of the first dose of CPT-11. * Short gut syndrome or other causes of malabsorption. * Colony stimulating factors within 2 weeks. * Women of childbearing potential not practicing birth control. (Note: by means other than oral contraception) * Pregnant women * Severe peripheral neuropathy grade 2 or higher. * Medical or psychiatric conditions which may impair the patient's ability to provide informed consent. * Hypersensitivity to CPT-11, raltegravir or midazolam/other benzodiazepines. * Rapidly progressive intracranial or spinal metastatic disease.
References
Publications (3)
- BACKGROUNDAtsumi R, Suzuki W, Hakusui H. Identification of the metabolites of irinotecan, a new derivative of camptothecin, in rat bile and its biliary excretion. Xenobiotica. 1991 Sep;21(9):1159-69. doi: 10.3109/00498259109039556. PMID 1788984
- BACKGROUNDGupta E, Mick R, Ramirez J, Wang X, Lestingi TM, Vokes EE, Ratain MJ. Pharmacokinetic and pharmacodynamic evaluation of the topoisomerase inhibitor irinotecan in cancer patients. J Clin Oncol. 1997 Apr;15(4):1502-10. doi: 10.1200/JCO.1997.15.4.1502. PMID 9193346
- DERIVEDLee LS, Seng KY, Wang LZ, Yong WP, Hee KH, Soh TI, Wong A, Cheong PF, Soong R, Sapari NS, Soo R, Fan L, Lee SC, Goh BC. Phenotyping of UGT1A1 Activity Using Raltegravir Predicts Pharmacokinetics and Toxicity of Irinotecan in FOLFIRI. PLoS One. 2016 Jan 25;11(1):e0147681. doi: 10.1371/journal.pone.0147681. eCollection 2016. PMID 26808671