Unspecified Adult Solid Tumor, Protocol Specific Clinical Trial
Official title:
A Phase Ib Study of Dovitinib in Combination With Gemcitabine and Nab-Paclitaxel in Patients With Advanced Solid Tumors and Pancreatic Cancer
This phase I trial studies the highest and safest doses of dovitinib lactate, paclitaxel albumin-stabilized nanoparticle formulation, and gemcitabine hydrochloride when given together. Dovitinib lactate disrupts the activity of fibroblast growth factor receptors and reduces cancer growth and spread. Gemcitabine hydrochloride and paclitaxel albumin-stabilized nanoparticle formulation are anti-cancer drugs for treating many cancer types.
PRIMARY OBJECTIVES:
I. To determine the maximum tolerated dose and recommended phase II dose of dovitinib
(dovitinib lactate) when administered concurrently with gemcitabine (gemcitabine
hydrochloride) and nab-paclitaxel (paclitaxel albumin-stabilized nanoparticle formulation)
in patients with advanced solid malignancies.
II. To characterize the safety profile of dovitinib, gemcitabine and nab-paclitaxel
combination in patients with advanced solid malignancies.
SECONDARY OBJECTIVES:
I. To characterize the pharmacokinetic profile of dovitinib, nab-paclitaxel, gemcitabine and
their metabolites when administered concurrently in patients with advanced solid
malignancies.
II. To determine the preliminary efficacy of the study combination in patients with advanced
solid tumors and pancreas adenocarcinoma.
III. To explore serum and tumor biomarkers predictive of efficacy to the study combination.
OUTLINE: This is a dose-escalation study of dovitinib lactate.
Patients receive dovitinib lactate orally (PO) once daily (QD) 5 days per week, paclitaxel
albumin-stabilized nanoparticle formulation intravenously (IV) over 30 minutes, and
gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15. Courses repeat every 28
days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up for 4 weeks.
;
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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