Phase I study of the effects of renal impairment on the pharmacokinetics and safety of satraplatin in patients with refractory solid tumors Journal Article


Authors: Galsky, M. D.; Camacho, L. H.; Chiorean, E. G.; Mulkerin, D.; Hong, D. S.; Oh, W. K.; Bajorin, D. F.
Article Title: Phase I study of the effects of renal impairment on the pharmacokinetics and safety of satraplatin in patients with refractory solid tumors
Abstract: Background: Satraplatin is an oral platinum analog with demonstrated activity in a range of malignancies. The current study was designed to evaluate the effect of varying degrees of renal impairment on the safety and pharmacokinetics (PKs) of satraplatin. Patients and methods: Patients with advanced solid tumors, refractory to standard therapies, were eligible. The study included four cohorts of patients with varying levels of renal function, and eight patients per cohort: Group 1 (G1) = normal renal function; G2 = mild renal impairment [creatinine clearance (CrCl) 50-80 ml/min]; G3 = moderate impairment (CrCl 30 to <50 ml/min); G4 = severe impairment (CrCl <30 ml/min). Satraplatin was administered orally at 80 mg/m 2/day on days 1-5 every 35 days. Results: A total of 32 patients were enrolled, 8 patients in each renal function group. Each group tolerated the dose of 80 mg/m 2/day on days 1-5 every 35 days without the need for dose deescalation. The most common adverse events were fatigue (63%), nausea (56%), diarrhea (53%), anorexia (47%), constipation (38%), vomiting (28%), anemia, dyspnea, and thrombocytopenia (25%). There were no dose-limiting toxic effects in any study group. There was increased exposure to plasma platinum and plasma ultrafiltrate platinum in patients with moderate to severe renal impairment. Conclusions: Satraplatin PKs was altered in patients with renal impairment. However, a corresponding increase in satraplatin-related toxic effects was not observed. © The Author 2011. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved.
Keywords: chemotherapy; solid tumors; phase i; renal impairment; satraplatin
Journal Title: Annals of Oncology
Volume: 23
Issue: 4
ISSN: 0923-7534
Publisher: Oxford University Press  
Date Published: 2012-04-01
Start Page: 1037
End Page: 1044
Language: English
DOI: 10.1093/annonc/mdr358
PROVIDER: scopus
PUBMED: 21828377
DOI/URL:
Notes: --- - "Export Date: 1 May 2012" - "CODEN: ANONE" - "Source: Scopus"
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  1. Dean Bajorin
    601 Bajorin