Cited by 197Adrenal and Paraganglionic TumorsAdrenal Hormones and DisordersGrowth Hormone and Insulin-like Growth Factors

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Safety, tolerability, and pharmacokinetics of the anti-IGF-1R monoclonal antibody figitumumab in patients with refractory adrenocortical carcinoma

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Haluska, Paul, Worden, Frank, Olmos, David, Yin, Donghua, Schteingart, David, Batzel, Gretchen N., Paccagnella, M. Luisa, de Bono, Johann S., Gualberto, Antonio, Hammer, Gary D.·2010·Cancer Chemotherapy and Pharmacology

DOI 10.1007/s00280-009-1083-9PMC PMC2875253

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Abstract

Purpose Insulin-like growth factor 1 receptor signaling through upregulation of the stimulatory ligand IGF-II has been implicated in the pathogenesis of adrenocortical carcinoma. As there is a paucity of effective therapies, this dose expansion cohort of a phase 1 study was undertaken to determine the safety, tolerability, pharmacokinetics, and effects on endocrine markers of figitumumab in patients with adrenocortical carcinoma.Methods Figitumumab was administered on day 1 of each 21-day cycle at the maximal feasible dose (20 mg/kg) to a cohort of patients with metastatic, refractory adrenocortical carcinoma. Serum glucose, insulin, and growth hormone were measured pre-study, at cycle 4 and study end. Pharmacokinetic evaluation was performed during cycles 1 and 4.Results Fourteen patients with adrenocortical carcinoma received 50 cycles of figitumumab at the 20 mg/kg. Treatment-related toxicities were generally mild and included hyperglycemia, nausea, fatigue, and anorexia. Single episodes of grade 4 hyperuricemia, proteinuria, and elevated gamma-glutamyltransferase were observed. Pharmacokinetics of figitumumab was comparable to patients with solid tumors other than adrenocortical carcinoma. Treatment with figitumumab increased serum insulin and growth hormone levels. Eight of 14 patients (57%) had stable disease.Conclusions The side effect profile and pharmacokinetics of figitumumab were similar in patients with adrenocortical carcinoma in comparison to patients with other solid tumors. While hyperglycemia was the most common adverse event, no clear patterns predicting severity were observed. The majority of patients receiving protocol therapy with single agent figitumumab experienced stability of disease, warranting further evaluation.

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Authors: Haluska, P., Worden, F., Olmos, D., Yin, D., Schteingart, D., Batzel, G. N., Paccagnella, M. L., de Bono, J. S., Gualberto, A., & Hammer, G. D.
Affiliations: Mayo Clinic (US)
University of Michigan (US)
Royal Marsden NHS Foundation Trust (GB)
Pfizer (United States) (US)
Corresponding author: Haluska, Paul
Hammer, Gary D.
ORCID: Haluska, Paul
Olmos, David
Gualberto, Antonio
Hammer, Gary D.
Venue: Cancer Chemotherapy and Pharmacology
Publisher: Springer Science and Business Media LLC
Published: 2009-08-02
Volume: 65
Issue: 4
Pages: 765-773
ISSN: 0344-5704 (ISSN-L)
1432-0843
DOI: 10.1007/s00280-009-1083-9
PMC: PMC2875253
OpenAlex: W2065302180
Cited by: 197
References: 41
Citations by year: 2026: 4 · 2025: 7 · 2024: 4 · 2023: 5 · 2022: 6 · 2021: 5 · 2020: 13 · 2019: 8 · 2018: 13 · 2017: 8 · 2016: 17 · 2015: 17 · 2014: 18 · 2013: 20 · 2012: 20
FWCI: 17.53
Type: journal article
Language: en
Open access: green
www.ncbi.nlm.nih.gov
Licence: www.springer.com/tdm (tdm)
Locations: Cancer Chemotherapy and Pharmacology (publishedVersion)
PubMed (publishedVersion)
PubMed Central (acceptedVersion)
Funders: National Cancer Institute (K12CA090628)
Topics: Health Sciences › Medicine › Surgery › Adrenal and Paraganglionic Tumors
Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Adrenal Hormones and Disorders
Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Growth Hormone and Insulin-like Growth Factors
Keywords: figitumumab, adrenocortical carcinoma, pharmacokinetics, safety and tolerability, hyperglycemia, insulin-like growth factor II, growth hormone, serum insulin, disease stability
MeSH terms: Adrenal Cortex Neoplasms, Adult, Aged, Anorexia, Antibodies, Monoclonal, Drug Administration Schedule, Fatigue, Female, Humans, Hyperglycemia, Infusions, Intravenous, Insulin, Male, Metabolic Clearance Rate, Middle Aged, Nausea, Growth Hormone, Cohort Studies, Immunoglobulins, Intravenous, Treatment Outcome, Receptor, IGF Type 1, Adrenocortical Carcinoma, Area Under Curve, Young Adult

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Safety, tolerability, and pharmacokinetics of the anti-IGF-1R monoclonal antibody figitumumab in patients with refractory adrenocortical carcinoma

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