Treatment and prognostic monitoring of cancerous proliferation disorders using Hedgehog pathway inhibitors
First Claim
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1. A method for treating a cancer in a subject, comprising orally administering a composition comprising a solid dispersion of a Hedgehog pathway (HhP) inhibitor and a polycarboxylic acid polymer, to the subject, wherein the HhP inhibitor comprises itraconazole, or a pharmaceutically acceptable salt, prodrug, stereoisomer, or active metabolite thereof, wherein:
- (a) the composition is orally administered in an effective amount to achieve a plasma trough level of at least about 1,000 ng/mL of the HhP inhibitor;
or (b) the composition is orally administered at a dose in the range of 100 mg to 600 mg HhP inhibitor per day.
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Abstract
The present invention concerns methods for treating a proliferation disorder, such as prostate cancer, basal cell carcinoma, lung cancer, and other cancers, using an inhibitor of the Hedgehog pathway (HhP); and methods for monitoring subjects undergoing such treatments based on biomarkers and other criteria predictive of efficacy.
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21 Claims
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1. A method for treating a cancer in a subject, comprising orally administering a composition comprising a solid dispersion of a Hedgehog pathway (HhP) inhibitor and a polycarboxylic acid polymer, to the subject, wherein the HhP inhibitor comprises itraconazole, or a pharmaceutically acceptable salt, prodrug, stereoisomer, or active metabolite thereof, wherein:
- (a) the composition is orally administered in an effective amount to achieve a plasma trough level of at least about 1,000 ng/mL of the HhP inhibitor;
or (b) the composition is orally administered at a dose in the range of 100 mg to 600 mg HhP inhibitor per day. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21)
- (a) the composition is orally administered in an effective amount to achieve a plasma trough level of at least about 1,000 ng/mL of the HhP inhibitor;
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