Pharmacokinetic Drug-drug Interaction Study of Dovitinib (TKI258) in Patients With Advanced Solid Tumors
| Status: | Completed |
|---|---|
| Conditions: | Breast Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 10/2/2013 |
| Start Date: | May 2012 |
| End Date: | July 2013 |
| Contact: | Novartis Pharmaceuticals |
| Phone: | +1(800)340-6843 |
A Phase I, Multi-center, Open-label, Drug-drug Interaction Study to Assess the Effect of TKI258 on the Pharmacokinetics of Caffeine, Diclofenac, Omeprazole and Midazolam Administered as a Four-drug Cocktail in Patients With Advanced Solid Tumors, Excluding Breast Cancer
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.
Inclusion Criteria:
- Patients with a cytopathologically or histopathologically confirmed diagnosis of an
advanced solid tumor, excluding breast cancer which has progressed despite standard
therapy or for which no standard therapy exists
- ECOG performance status 0 or 1 and anticipated life expectancy ≥ 3 months
- Patient must meet protocol-specific laboratory values
Exclusion Criteria:
- Patients with brain metastases
- Patients who have received or who are expected to receive any prohibited medications
and therapies
- Patients who have received CYP1A2 inducer, CYP2C9/2C19 inducer or CYP3A4 inducer
medications within 30 days prior to start study treatment or are expected to receive
during the first 14 days after starting the study treatment
- Patients with a known hypersensitivity to benzodiazepines
- Patients who have not recovered from previous anti-cancer therapies
- Patient with impairment of gastrointestinal (GI) function or GI disease that may
significantly alter the absorption of TKI258
- Patients who have concurrent severe and/or uncontrolled concomitant medical
conditions that could compromise participation in the study
- Female patients who are pregnant or breast-feeding
- Fertile males or women not willing to use highly effective methods of contraception
- Other protocol-defined inclusion/exclusion criteria will apply
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