Safety, tolerability, and pharmacokinetics of the anti-IGF-1R monoclonal antibody figitumumab in patients with refractory adrenocortical carcinoma
Open accessAbstract
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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In a phase 2 study of figitumumab in patients with advanced ACC, 8 of 14 patients had stable disease as their best response, but after 7 cycles (~6 months) all patients showed disease progression.
“Eight of 14 patients had stable disease as their best response. However, after 7 cycles (∼6 months), all patients showed disease progression.”
From Adrenocortical carcinoma (2014) · cites this paper as [316]
Eight of 14 patients treated with figtilimumab had stable disease as their best response.
“Eight of 14 patients had stable disease as their best response.”
From Adrenocortical carcinoma (2014) · cites this paper as [316]
In the first study of figtilimumab, treatment-related toxicities were generally mild and mainly included hyperglycemia, nausea, fatigue, and anorexia.
“The first study investigated figtilimumab, a fully human monoclonal antibody directed toward IGF-1R (316). Treatment-related toxicities were generally mild and mainly included hyperglycemia, nausea, fatigue, and anorexia.”
From Adrenocortical carcinoma (2014) · cites this paper as [316]
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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.
- Venue
- Cancer Chemotherapy and Pharmacology
- Published
- 2009-08-02
- Volume
- 65
- Issue
- 4
- Pages
- 765-773
- ISSN
- 0344-5704 (ISSN-L)
- 1432-0843
- 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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