Clinical trial · Interventional
A Study To Test The Effect Of GW786034 (Pazopanib) On P450 Enzymes
A Multi-center, Open-Label, Multiple-probe Drug Interaction Study to Determine the Effects of GW786034 on the Metabolism of Cytochrome P450 Probe Drugs in Patients With Solid Tumors
NCT00401583CI-TRIAL-00030306completedPhase 1ClinicalTrials.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)
This is a Phase I study to determine the effect of GW786034 (pazopanib) on P450 enzymes. This study will help determine which types of drugs may interact with GW786034.
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 |
|---|---|---|---|
| Carcinoma, Renal Cell | Renal Cell Carcinoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| GW786034 (pazopanib) | Drug | Pazopanib | ALIAS |
| Probe drugs | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Pazopanib receivers
- description
- During Days 1 and 2 subjects will be dosed with only probe drugs, and with no drugs on Days 3-5. During Days 6 to the end of the study, subjects will receive 800 mg daily pazopanib, and on Days 23-24 subjects will receive probe drugs in addition to pazopanib
- interventionNames
- Drug: GW786034 (pazopanib)
- Drug: Probe drugs
Primary outcomes (1)
- measure
- To investigate the potential of GW786034 to inhibit or induce various CYP450 enzymes.
- timeFrame
- throughout the study
Secondary outcomes (1)
- measure
- Safety of co-administration of 800 mg daily GW786034 and CYP450 probe drugs. To describe GW786034 steady-state pharmacokinetics on this once daily dosing regimen.
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 21 Years
Show eligibility criteria text
Inclusion criteria: * Histologically or cytologically confirmed diagnosis of advanced solid tumors. * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. * Adequate bone marrow, renal, lung, and liver function. * A female subject must not be pregnant and will agree not to become pregnant during the trial Exclusion criteria: * Any major surgery, chemotherapy, hormone therapy, investigational drugs, or radiotherapy within the last 28 days. * Poorly controlled hypertension. * Corrected QT (QTc) prolongation defined as a QTc interval greater than or equal to 480 msec and a prior history of cardiovascular disease, arrhythmias, or significant ECG abnormalities. * Arterial or venous thrombi (including cerebrovascular accident), myocardial infarction, admission for unstable angina, cardiac angioplasty, or stenting within the last 3 months. * Current use of therapeutic anticoagulation (low molecular weight heparin, oral anticoagulant agents). Amiodarone must not have been taken for at least 6 months prior to the administration of the first dose of study drug. * History of brain metastases. * Has narrow-angle glaucoma which is a contraindication to midazolam use. * History of nicotine-containing product (including cigarettes, cigars, nicotine patches) use within the past 6 months. * A history of bleeding problems.
References
Publications (1)
- BACKGROUNDGoh BC, Reddy NJ, Dandamudi UB, Laubscher KH, Peckham T, Hodge JP, Suttle AB, Arumugham T, Xu Y, Xu CF, Lager J, Dar MM, Lewis LD. An evaluation of the drug interaction potential of pazopanib, an oral vascular endothelial growth factor receptor tyrosine kinase inhibitor, using a modified Cooperstown 5+1 cocktail in patients with advanced solid tumors. Clin Pharmacol Ther. 2010 Nov;88(5):652-9. doi: 10.1038/clpt.2010.158. Epub 2010 Sep 29. PMID 20881954