A phase I, multi-center, open-label, drug-drug interaction study to assess the effect of the CYP1A2 inhibitor, fluvoxamine, on TKI258 (dovitinib) pharmacokinetics in patients with advanced solid tumors. - A phase I drug-drug interaction study of fluvoxamin on TKI258 (dovitinib)

ovartis0 sites12 target enrollmentTBD

Overview

No summary available.

Registry

who.int

Start Date

TBD

End Date

TBD

Last Updated

2 years ago

Study Type

Interventional

Sponsor

•1\. Patients diagnosed with either an advanced solid tumor, excluding breast cancer, or advanced hepatocellular carcinoma, which has progressed despite standard therapy, or for which no standard therapy exists
•2\. ECOG performance status \<\= 2
•3\. Absolute neutrophil count \>\= 1\.5 x 109/L
•4\. Platelets \>\= 100 x 109/L
•5\. Hemoglobin \>\= 8\.0 g/dL \= 4\.96 mmol/L
•6\. Serum creatinine \<\= 1\.5 x ULN or 24\-hour urine collection creatinine clearance \>\= 30 mL/min/1\.73m2 (\>\= 50 mL/min/1\.73m2 in the presence of proteinuria as defined in inclusion criterion \#9\) or,
•Serum creatinine \> 1\.5 \- 3 x ULN with calculated creatinine clearance \>\= 30 mL/min using the Cockcroft\-Gault equation
•7\. Serum total bilirubin \<\= 1\.5 x ULN
•8\. AST and ALT \<\= 3\.0 x ULN
•9\. Urine dipstick negative for proteinuria or, if documentation of \+1 results (\+ 2 for patients with RCC) for protein on dipstick reading, then total urinary protein \<\= 500 mg and measured creatinine clearance \>\= 50 L/min/1\.73m3 from a 24 hour urine collection

•1\. Patients with brain metastases as assessed by mandatory radiologic imaging at screening
•2\. Patients with a history of another primary malignancy that is currently clinically significant or currently requires active intervention
•3\. Prior anticancer therapies:
•targeted small molecule therapy \<\= 2 weeks prior to starting study drug,
•monoclonal antibody, immunotherapy, hormonal therapy, or chemotherapy \<\= 4 weeks prior to starting study drug,
•nitrosourea or mitomycin\-C \<\= 6 weeks prior to starting study drug
•radiotherapy \<\= 4 weeks prior to starting the study drug (palliative radiotherapy for bone lesions \<\= 2 weeks prior to starting study drug is allowed)
•and not recovered from anti\-cancer therapy related toxicities
•4\. Major surgery \<\= 4 weeks prior to starting study treatment, or who have not recovered from side effects of such therapy
•5\. Pulmonary embolism or untreated deep venous thrombosis within 6 months prior to starting study drug