Cited by 181Lung Cancer Treatments and MutationsHER2/EGFR in Cancer ResearchCancer Mechanisms and Therapy

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Phase I Dose-Escalation Study of the Pan-HER Inhibitor, PF299804, in Patients with Advanced Malignant Solid Tumors

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Jänne, Pasi A., Boss, David S., Camidge, D. Ross, Britten, Carolyn D., Engelman, Jeffrey A., Garon, Edward B., Guo, Feng, Wong, Steven, Liang, Jane, Letrent, Stephen, Millham, Robert, Taylor, Ian, Eckhardt, S. Gail, Schellens, Jan H.M.·2011·Clinical Cancer Research

DOI 10.1158/1078-0432.ccr-10-1220PMC PMC3048920

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Abstract

Purpose: PF299804 is a potent, orally available, irreversible inhibitor of tyrosine kinase human epidermal growth factor receptors (HER) 1 (EGFR), HER2, and HER4. This first-in-human study investigated the safety, tolerability, pharmacokinetics, and pharmacodynamics of PF299804 in patients with advanced solid malignancies. Experimental Design: PF299804 was administered once daily continuously (schedule A) and intermittently (schedule B). Dose escalation proceeded until intolerable toxicities occurred. Skin biopsies were taken predose and after 14 days of treatment to establish a pharmacokinetic/pharmacodynamic relationship. Tumor response was measured once every 2 cycles. Efficacy was correlated with tumor genotypes in non–small cell lung cancer (NSCLC) patients. Results: 121 patients were included (111 in schedule A, 10 in schedule B). The maximum tolerated dose (MTD) was 45 mg/d. Dose-limiting toxicities included stomatitis and skin toxicities. Most adverse events were mild and comprised skin toxicities, fatigue, and gastrointestinal side-effects including diarrhea, nausea, and vomiting. Pharmacokinetic analyses revealed dose-dependent increases in PF299804 exposure associated with target inhibition in skin biopsy samples. Fifty-seven patients with non–small cell lung cancer (NSCLC) were treated in this study. Four patients, all previously treated with gefitinib or erlotinib (2 with exon 19 deletions, 1 with exon 20 insertion, 1 mutational status unknown), had a partial response to PF299804. Conclusions: The MTD of PF299804 is 45 mg/d. Both continuous and intermittent treatment schedules were well tolerated, and encouraging signs of antitumor activity were observed in gefitinib/erlotinib treated NSCLC patients. Clin Cancer Res; 17(5); 1131–9. ©2011 AACR.

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First-in-human study of PF-00299804, a small molecule irreversible panHER inhibitor in patients with advanced cancer: Update on safety and pharmacokinetics and initial report on pharmacodynamic responses and clinical benefit.
Camidge, D. R., Britten, C. D., Schellens, J. H. M., Guo, F., Millham, R., Eckhardt, S., Wong, S., Boss, D. S., Lucca, J. V., & Janne, P. A. (2007) · Molecular Cancer Therapeutics
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Mok, T. S. K., Spigel, D. R., Park, K., Socinski, M. A., Tung, S. Y., Kim, D. S., Borzillo, G. V., Zhang, H., O'Connell, J. P., & Janne, P. A. (2010) · Journal of Clinical Oncology · doi:10.1200/jco.2010.28.15_suppl.7537 · Cited by 25
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First-in-human study of the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of PF-00299804, a small molecule irreversible panHER inhibitor in patients with advanced cancer
Schellens, J. H. M., Britten, C. D., Camidge, D. R., Boss, D. S., Wong, S., Diab, S., Guo, F., Maguire, R. P., Letrent, S. P., & Eckhardt, S. (2007) · Journal of Clinical Oncology · doi:10.1200/jco.2007.25.18_suppl.3599 · Cited by 13
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Authors: Jänne, P. A., Boss, D. S., Camidge, D. R., Britten, C. D., Engelman, J. A., Garon, E. B., Guo, F., Wong, S., Liang, J., Letrent, S., Millham, R., Taylor, I., Eckhardt, S. G., & Schellens, J. H. M.
Affiliations: Authors' Affiliations: 1Dana Farber Cancer Institute and 2Massachusetts General Hospital Cancer Center, Boston, Massachusetts; 3Netherlands Cancer Institute, Division of Clinical Pharmacology, Amsterdam, The Netherlands; 4University of Colorado, Denver, Aurora, Colorado; 5University of California Los Angeles, UCLA Medical Center, Los Angeles, California; 6Clinical Pharmacology and Pharmacometrics, Pfizer (China) Research and Development Center, Shanghai, P.R. China; 7Pfizer Oncology, New London, Connecticut; 8Clinical Development and Medical Affairs, Pfizer Oncology, San Diego, California; and 9Faculty of Pharmaceutical Sciences, Division of Drug Toxicology, University Utrecht, Utrecht, the Netherlands
University of California, Los Angeles (US)
ORCID: Camidge, D. Ross
Engelman, Jeffrey A.
Garon, Edward B.
Schellens, Jan H.M.
Venue: Clinical Cancer Research
Publisher: American Association for Cancer Research (AACR)
Published: 2011-03-01
Volume: 17
Issue: 5
Pages: 1131-1139
ISSN: 1078-0432 (ISSN-L)
1557-3265
DOI: 10.1158/1078-0432.ccr-10-1220
PMC: PMC3048920
OpenAlex: W2161152839
Cited by: 181
References: 23
Citations by year: 2026: 3 · 2025: 2 · 2024: 2 · 2023: 6 · 2022: 12 · 2021: 13 · 2020: 10 · 2019: 10 · 2018: 14 · 2017: 12 · 2016: 14 · 2015: 18 · 2014: 18 · 2013: 22 · 2012: 18
FWCI: 17.54
Type: journal article
Language: en
Open access: green
www.ncbi.nlm.nih.gov
Locations: Clinical Cancer Research (publishedVersion)
PubMed (publishedVersion)
Europe PMC (PubMed Central) (acceptedVersion)
PubMed Central (acceptedVersion)
Funders: Pfizer
National Institutes of Health
National Cancer Institute (P50CA090578, R01CA135257)
Topics: Health Sciences › Medicine › Pulmonary and Respiratory Medicine › Lung Cancer Treatments and Mutations
Health Sciences › Medicine › Oncology › HER2/EGFR in Cancer Research
Life Sciences › Biochemistry, Genetics and Molecular Biology › Cancer Research › Cancer Mechanisms and Therapy
Keywords: pan-HER inhibitor, EGFR, HER2, ErbB4, tyrosine kinase inhibitors, dose escalation, maximum tolerated dose, non-small cell lung cancer, stomatitis, skin toxicity, pharmacokinetics, pharmacodynamics, exon 19 deletion, exon 20 insertion, anticancer activity
MeSH terms: Erlotinib Hydrochloride, Gefitinib, Adult, Aged, Antineoplastic Agents, Carcinoma, Non-Small-Cell Lung, Female, Genotype, Heptanoic Acids, Humans, Lung Neoplasms, Male, Middle Aged, Mutation, Protein-Tyrosine Kinases, Pyrazoles, Quinazolines, Biomarkers, Tumor, Signal Transduction, Treatment Outcome, Erb-b2 Receptor Tyrosine Kinases, Maximum Tolerated Dose, ErbB Receptors, Receptor, ErbB-4

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Phase I Dose-Escalation Study of the Pan-HER Inhibitor, PF299804, in Patients with Advanced Malignant Solid Tumors

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