Dovitinib Lactate in Treating Patients With Pancreatic Neuroendocrine

Status Withdrawn

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02108782
Study type	Interventional
Source	Academic and Community Cancer Research United
Contact
Status	Withdrawn
Phase	Phase 2
Start date	October 2014
Completion date	May 2015

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Dovitinib Lactate in Treating Patients With Pancreatic Neuroendocrine Tumors

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms