A Phase 1 interventional study of dovitinib (TKI258) and fluvoxamine in Advanced Solid Tumors, Excluding Breast Cancer, sponsored by Novartis Pharmaceuticals. Completed at 6 sites in 4 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-12-21.
Sponsored by Novartis Pharmaceuticals · Phase 1, Interventional, and Treatment
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.
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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:
dovitinib, 5 days on / 2 days off dose schedule
Drug: dovitinib (TKI258) · Drug: fluvoxamine
perpetrator drug; 7 days of dosing
TKI258 pharmacokinetics (PK) parameters: Cmax (Maximum (peak) concentration of drug)
Time frame: multiple time-points over 72h post dose on day Day 19 and Day 26 (PK phase)
TKI258 pharmacokinetics (PK) parameters: AUC 0-24 hr (Area Under the Curve)
Time frame: multiple time-points over 72h post dose on day Day 19 and Day 26 (PK phase)
TKI258 pharmacokinetics (PK) parameters: AUC 0-72 hr
Time frame: multiple time-points over 72h post dose on day Day 19 and Day 26 (PK phase)
TKI258 pharmacokinetics (PK) parameters: Tmax (Time to maximum concentration)
Time frame: multiple time-points over 72h post dose on day Day 19 and Day 26 (PK phase)
TKI258 pharmacokinetics (PK) parameters: T1/2 (Half-life time)
Time frame: multiple time-points over 72h post dose on day Day 19 and Day 26 (PK phase)
TKI258 pharmacokinetics (PK) parameters: CL/F (Apparent Oral Clearance)
Time frame: multiple time-points over 72h post dose on day Day 19 and Day 26 (PK phase)
TKI258 pharmacokinetics (PK) parameters: Vz/F (apparent volume of distribution)
Time frame: multiple time-points over 72h post dose on day Day 19 and Day 26 (PK phase)
Frequency and severity of AEs (Adverse Events)
Time frame: up to at least 30 days after the last dose of dovitinib (TKI258)
Frequency and severity of SAEs (Serious Adverse Events)
Time frame: up to at least 30 days after the last dose of dovitinib (TKI258)
Preliminary evidence of antitumor activity of dovitinib (TKI258)
overall response based on investigator assessment and best overall response using RECIST 1.1
Time frame: every 8 weeks until progression of disease
This study is completed, as verified in Nov 2014. You cannot join it, but the record below documents what was studied.
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Novartis Pharmaceuticals