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NCT01596647 · ClinicalTrials.gov registry record · Phase 1
Pharmacokinetic Drug-drug Interaction Study of Dovitinib (TKI258) in Patients With Advanced Solid Tumors
A Phase 1 study, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 39
- Enrollment target
NCT01596647 is a Phase 1 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 39 participants.
The verdict
NCT01596647, a Phase 1 study, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 39 participants
- Enrollment target
Study Summary
This is a multi-center, open-label, phase I study to assess the effects of dovitinib (TKI258) on the pharmacokinetics of a cocktail of caffeine, diclofenac, omeprazole and midazolam in patients with advanced solid tumors, excluding breast cancer. The aim of this study is to evaluate the potential effect of dovitinib (TKI258) on the metabolism of the probe drugs caffeine, diclofenac, omeprazole and midazolam, which are metabolized by CYP1A2, CYP2C9, CYP2C19 and CYP3A4 respectively (Cytochrome P450 isoenzyme), comparing the single-dose pharmacokinetics (AUCtlast, AUCinf and Cmax parameters) of each of the individual probe drug co-administered with and without multiple dose of dovitinib (TKI258) 500 mg under a 5 days on / 2 days off dose schedule. The study foresees two treatment phases: DDI (drug-drug interaction) followed by post-DDI. During the DDI phase patients receive treatment with the probe drug cocktail and dovitinib (TKI258). During the post-DDI phase patients may continue to receive treatment with dovitinib (TKI258) until disease progression (assessed by RECIST 1.1), unacceptable toxicity, death or discontinuation from the study treatment for any other reason.
Interventions
- DRUG midazolam
- DRUG omeprazole
- DRUG TKI258
- DRUG caffeine
- DRUG diclofenac
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 39 participants |
| Start Date | 2012-05 |
| Est. Completion | 2014-07 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01596647
The ClinicalTrials.gov registry entry for NCT01596647 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 39 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Novartis Pharmaceuticals, which has 1,375 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which midazolam is the first listed.
NCT01596647 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01596647 about?
NCT01596647 is a clinical study titled "Pharmacokinetic Drug-drug Interaction Study of Dovitinib (TKI258) in Patients With Advanced Solid Tumors". This is a multi-center, open-label, phase I study to assess the effects of dovitinib (TKI258) on the pharmacokinetics of a cocktail of caffeine, diclofenac, omeprazole and midazolam in patients with advanced solid tumors, excluding breast cancer. The aim of this study is to evaluate the potential ef...
What is the current status of trial NCT01596647?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 39 participants. The study started on 2012-05. Estimated completion is 2014-07.
What interventions are being tested in trial NCT01596647?
The interventions under investigation include: midazolam (DRUG), omeprazole (DRUG), TKI258 (DRUG), caffeine (DRUG), diclofenac (DRUG).
Who is sponsoring clinical trial NCT01596647?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
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