NCT02108782

Dovitinib Lactate in Treating Patients With Pancreatic Neuroendocrine Tumors

Phase II Study of Dovitinib (TKI-258) in Progressive, Well-Differentiated Pancreatic Neuroendocrine Tumors With and Without Prior VEGF-Inhibitor Therapy

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Academic and Community Cancer Research United · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase II trial studies how well dovitinib lactate works in treating patients with pancreatic neuroendocrine tumors. Dovitinib lactate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Detailed description

PRIMARY OBJECTIVES: I. To evaluate the efficacy of dovitinib (dovitinib lactate) in patients with progressive well-differentiated neuroendocrine tumors of the pancreas (PNETs) in reference to 6-month progression free survival (PFS) historical-controlled patients and in two cohorts defined by prior vascular endothelial growth factor (VEGF)-inhibitor therapy (Cohort 1 - no prior VEGF, Cohort 2 - prior VEGF). SECONDARY OBJECTIVES: I. To determine the safety of dovitinib in patients with progressive well-differentiated PNETs. II. To evaluate time to treatment failure, time to progression, and overall survival. III. To evaluate radiographic and biochemical response rates. TERTIARY OBJECTIVES: I. To assess the pharmacodynamic effect of dovitinib on plasma biomarkers by measuring concentrations of circulating growth factors and soluble receptors (e.g. basic fibroblast growth factor \[bFGF\], VEGF, placental growth factor \[PLGF\], soluble VEGF receptor 1 (sVEGFR1) and 2, collagen IV, fibroblast growth factor 23 \[FGF23\]). II. Archival tissue collected from patients prior to registration will be banked to later analyze baseline expression of potential biomarkers (e.g., bFGF, FGFR). OUTLINE: Patients receive dovitinib lactate orally (PO) on days 1-5, 8-12, 15-19, and 22-26. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 2 months for 6 months, every 3 months for 6 months, and then periodically for 2 years.

Conditions

• Gastrinoma
• Glucagonoma
• Insulinoma
• Pancreatic Polypeptide Tumor
• Recurrent Islet Cell Carcinoma
• Somatostatinoma

Interventions

Type	Name	Description
DRUG	dovitinib lactate	Given PO
OTHER	pharmacological study	Correlative studies
OTHER	laboratory biomarker analysis	Correlative studies

Timeline

• Start date: 2014-10-01
• Primary completion: 2015-05-01
• Completion: 2015-05-01
• First posted: 2014-04-09
• Last updated: 2017-07-19