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    ZD1839, a selective oral epidermal growth factor receptor-tyrosine kinase inhibitor, is well tolerated and active in patients with solid, malignant tumors: results of a phase I trial.

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    Authors
    Ranson, Malcolm
    Hammond, Lisa A.
    Ferry, David R.
    Kris, Mark
    Tullo, Andrew
    Murray, Philip I.
    Miller, Vince
    Averbuch, Steve
    Ochs, Judy
    Morris, Charles
    Feyereislova, Andrea
    Swaisland, Helen
    Rowinsky, Eric K.
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    Issue Date
    2002
    
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    Abstract
    PURPOSE: To investigate the tolerability, pharmacokinetics, and antitumor activity of the oral, selective epidermal growth factor receptor-tyrosine kinase inhibitor ZD1839 in patients with solid malignant tumors. PATIENTS AND METHODS: This was an open, phase I, escalating multiple-dose tolerability and pharmacokinetic trial. ZD1839 was administered once daily for 14 consecutive days followed by 14 days off treatment. Dose escalation started at 50 mg/d and continued to 925 mg or until consistent dose-limiting toxicity (DLT) was observed. RESULTS: Sixty-four patients were entered at eight dose levels. The most frequent dose-related grade 1 and 2 adverse events were an acne-like (or folliculitis) rash, nausea, and diarrhea. Three of nine patients treated at 700 mg/d developed DLT (reversible grade 3 diarrhea); grade 3 and 4 events were uncommon. Exposure to ZD1839 was dose proportional, and the mean terminal half-life was 48 hours (range, 37 to 65). Four of 16 patients with non-small-cell lung cancer (NSCLC) had objective partial responses observed from ZD1839 300 to 700 mg/d. Overall, 16 patients remained on study for > or = 3 months, with seven of these patients (five with NSCLC, including three of the patients with partial response) remaining on study for > or = 6 months. CONCLUSION: ZD1839 was well tolerated, with DLT observed at a dose well above that at which antitumor activity was seen. Pharmacokinetic analysis confirmed that ZD1839 was suitable for administration as a once-daily oral tablet formulation. Phase II monotherapy and phase III combination trials in NSCLC are being conducted to investigate further the efficacy, tolerability, and optimal daily dose of ZD1839.
    Citation
    Journal of Clinical Oncology, 20(9): 2240-2250
    Publisher
    American Society of Clinical Oncology
    Journal
    Journal of Clinical Oncology
    URI
    http://hdl.handle.net/2436/29454
    PubMed ID
    11980995
    Additional Links
    http://jco.ascopubs.org/cgi/content/full/20/9/2240
    Type
    Journal article
    Language
    en
    ISSN
    0732-183X
    Collections
    Research Institute in Healthcare Science

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