drugset

drugset / Trial / NCT00953758

A Study Of PF-04449913 In Select Hematologic Malignancies

NCT00953758 ↗

Phase 1 Completed 47 enrolled Pfizer

Non-randomizedSequentialOpen-labelTreatment

Summary

This study examines the effect of a small molecule inhibitor to the Sonic Hedgehog pathway on select hematologic malignancies.

Timeline

Start: 2010-03-03
Primary completion: 2012-09-26
Completion: 2013-02-27

Publications

Fostvedt LK, Shaik N, Martinelli G, Wagner AJ, Ruiz-Garcia A. Exposure-response modeling of the effect of glasdegib on cardiac repolarization in patients with cancer. Expert Rev Clin Pharmacol. 2021 Jul;14(7):927-935. doi: 10.1080/17512433.2021.1925538. Epub 2021 May 18.
Martinelli G, Oehler VG, Papayannidis C, Courtney R, Shaik MN, Zhang X, O'Connell A, McLachlan KR, Zheng X, Radich J, Baccarani M, Kantarjian HM, Levin WJ, Cortes JE, Jamieson C. Treatment with PF-04449913, an oral smoothened antagonist, in patients with myeloid malignancies: a phase 1 safety and pharmacokinetics study. Lancet Haematol. 2015 Aug;2(8):e339-46. doi: 10.1016/S2352-3026(15)00096-4. Epub 2015 Jul 26.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Glasdegib	Small molecule	5 mg	Oral
Subject	Glasdegib	Small molecule	10 mg	Oral
Subject	Glasdegib	Small molecule	20 mg	Oral
Subject	Glasdegib	Small molecule	40 mg	Oral
Subject	Glasdegib	Small molecule	80 mg	Oral
Subject	Glasdegib	Small molecule	120 mg	Oral
Subject	Glasdegib	Small molecule	180 mg	Oral
Subject	Glasdegib	Small molecule	270 mg	Oral
Subject	Glasdegib	Small molecule	400 mg	Oral
Subject	Glasdegib	Small molecule	600 mg	Oral

Indications