Phase I Study of the Hedgehog Pathway Inhibitor IPI-926 in Adult Patients with Solid Tumors

    May 2013 in “ Clinical Cancer Research ”
    Antonio Jimeno, Glen J. Weiss, Wilson H. Miller, Scott Gettinger, Bernhard J. Eigl, Anne Lynne S Chang, Joi Dunbar, Shannon Devens, Kerrie Faia, Georgio Skliris, Jeffery L. Kutok, Karl D. Lewis, Raoul Tibes, William H. Sharfman, Robert W. Ross, Charles M. Rudin
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    TLDR The drug IPI-926 is safe at 160 mg daily and may help treat certain tumors, especially basal cell carcinoma.
    The phase I study conducted between October 2009 and June 2011 involved 94 adult patients with solid tumors refractory to standard therapy, who were treated with the Hedgehog pathway inhibitor IPI-926. The study aimed to assess the drug's safety, pharmacokinetics, and antitumor activity. The maximum tolerated dose was found to be 160 mg once daily, with common reversible toxicities including liver enzyme elevations, fatigue, nausea, and alopecia. Pharmacokinetic analysis supported once-daily dosing. Notably, 8 out of 28 patients with basal cell carcinoma (BCC) who had not previously received Hedgehog pathway inhibitors responded to IPI-926. The study concluded that IPI-926 was well tolerated and showed preliminary evidence of antitumor activity, especially in BCC patients, recommending a 160 mg daily dose for phase II trials.
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