Phase I dose-escalation study of long-acting pasireotide in patients with neuroendocrine tumors

This phase I study aimed at determining the maximum tolerated dose (MTD) and characterizing the safety, tolerability, pharmacokinetics (PKs), and efficacy of pasireotide in patients with advanced neuroendocrine tumors (NETs). Patients were enrolled in two phases: dose-escalation phase (to determine...

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Bibliographic Details
Published in:OncoTargets and therapy 2017-01, Vol.10, p.3177-3186
Main Authors: Yao, James C, Chan, Jennifer A, Mita, Alain C, Kundu, Madan G, Hermosillo Reséndiz, Karina, Hu, Ke, Ravichandran, Shoba, Strosberg, Jonathan R, Wolin, Edward M
Format: Article
Language:English
Subjects:
Analysis
Cancer
Cardiac arrhythmia
Care and treatment
Control
Development and progression
Diagnosis
Drug dosages
Heart rate
Laboratories
Metastasis
Neuroendocrine tumors
Original Research
Overdose
Patient outcomes
Patients
Pharmacodynamics
Pharmacokinetics
Studies
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Summary:This phase I study aimed at determining the maximum tolerated dose (MTD) and characterizing the safety, tolerability, pharmacokinetics (PKs), and efficacy of pasireotide in patients with advanced neuroendocrine tumors (NETs). Patients were enrolled in two phases: dose-escalation phase (to determine the MTD) at a starting dose of 80 mg pasireotide long-acting release (LAR) i.m. followed by a dose-expansion phase (to evaluate safety and prelimi-nary efficacy). Associations between PK/pharmacodynamic parameters and clinical outcomes were evaluated using linear regression analysis. A total of 29 patients were treated with 80 mg (n=13) and 120 mg (n=16) doses. Most common primary tumor sites included small intestine (44.8%), pancreas (24.1%), and lung (17.2%). No protocol-defined dose-limiting toxicities were observed in the study; however, in post hoc analysis, a higher incidence of bradycardia (heart rate [HR]
ISSN:1178-6930
1178-6930
DOI:10.2147/OTT.S128547