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: | 5/5/2014 |
| Start Date: | May 2013 |
| End Date: | April 2014 |
| Contact: | Novartis Pharmaceuticals |
| Phone: | 1-888-669-6682 |
A Phase I, Multi-center, Open-label, Drug-drug Interaction Study to Assess the Effect of the CYP1A2 Inhibitor, Fluvoxamine, on Dovitinib (TKI258) Pharmacokinetics in Patients With Advanced Solid Tumors
This is a multi-center, open-label, single-sequence, crossover, drug-drug interaction (DDI)
study to assess the effect of the CYP1A2 inhibitor, fluvoxamine, on the PK of dovitinib in
patients with advanced solid tumors, excluding breast cancer. The purpose of this study is
to evaluate the effect of a CYP1A2 inhibitor, 100 mg fluvoxamine, on the PK of dovitinib
when administered at a dose of 300 mg on the dosing schedule, 5 days on/2 days off. The
study will consist of 2 phases: a Pharmacokinetic (PK) phase and a clinical treatment phase.
The DDI test will be conducted in the PK phase. The DDI test will assess the steady state PK
profile of dovitinib when administered alone and in the presence of the CYP1A2 inhibitor,
fluvoxamine (AUC 0-24h, AUC 0-72h and Cmax parameters). During the clinical treatment phase
patients may continue to receive treatment with TKI258 until disease progression (assessed
by RECIST 1.1), unacceptable toxicity, death or discontinuation from the study treatment for
any other reason.
study to assess the effect of the CYP1A2 inhibitor, fluvoxamine, on the PK of dovitinib in
patients with advanced solid tumors, excluding breast cancer. The purpose of this study is
to evaluate the effect of a CYP1A2 inhibitor, 100 mg fluvoxamine, on the PK of dovitinib
when administered at a dose of 300 mg on the dosing schedule, 5 days on/2 days off. The
study will consist of 2 phases: a Pharmacokinetic (PK) phase and a clinical treatment phase.
The DDI test will be conducted in the PK phase. The DDI test will assess the steady state PK
profile of dovitinib when administered alone and in the presence of the CYP1A2 inhibitor,
fluvoxamine (AUC 0-24h, AUC 0-72h and Cmax parameters). During the clinical treatment phase
patients may continue to receive treatment with 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 an
anticipated life expectancy of ≥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 or
CYP3A inhibitor medications within 5 days prior to start study treatment or are expected
to receive during the first 28 days after starting the study treatment - Patients who have
received CYP1A2 or CYP3A inducer medications within 30 days prior to start study treatment
or are expected to receive during the first 28 days after starting the study treatment -
Patients who are actively taking antidepressants, benzodiazepines, serotonergic drugs,
and/or monoamine oxidase inhibitors (MAOIs) - 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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