Study of the Safety and Pharmacokinetics of XL147 (SAR245408) in Adults With Solid Tumors or Lymphoma

Phase 1 Completed 118 enrolled Sanofi

Non-randomizedSingle-groupOpen-labelTreatment

Summary

The purpose of this study is to evaluate the safety and tolerability of XL147 in subjects with solid tumors or lymphoma. Both a capsule and a tablet formulation will be evaluated. XL147 is a new chemical entity that inhibits PI3 Kinase. Inactivation of PI3K has been shown to inhibit growth and induce apoptosis (programmed cell death) in tumor cells.

Timeline

Start: 2007-06
Primary completion: 2012-10
Completion: 2012-10

Publications

Edelman G, Rodon J, Lager J, Castell C, Jiang J, Van Allen EM, Wagle N, Lindeman NI, Sholl LM, Shapiro GI. Phase I Trial of a Tablet Formulation of Pilaralisib, a Pan-Class I PI3K Inhibitor, in Patients with Advanced Solid Tumors. Oncologist. 2018 Apr;23(4):401-e38. doi: 10.1634/theoncologist.2017-0691. Epub 2018 Mar 28.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	pilaralisib	Small molecule	25 mg	Oral
Subject	pilaralisib	Small molecule	100 mg	Oral
Subject	pilaralisib	Small molecule	150 mg	Oral
Subject	pilaralisib	Small molecule	200 mg	Oral

Study of the Safety and Pharmacokinetics of XL147 (SAR245408) in Adults With Solid Tumors or Lymphoma

Summary

Timeline

Publications

Drugs

Indications