Safety Study of BEZ235 With Everolimus in Subjects With Advanced Solid Tumors

Phase 1 Terminated 19 enrolled University of Cincinnati Novartis · collab

NaSingle-groupOpen-labelTreatment

Summary

The purpose of this clinical trial is to determine the effects good or bad of combining BEZ235 along with Everolimus to determine if it is a safe treatment for patients with advanced cancers of different types.

Timeline

Start: 2012-01
Primary completion: 2014-02
Completion: 2014-12

Outcome

Outcome not reported

Stopped (Business): “funding”

Publications

Wise-Draper TM, Moorthy G, Salkeni MA, Karim NA, Thomas HE, Mercer CA, Beg MS, O'Gara S, Olowokure O, Fathallah H, Kozma SC, Thomas G, Rixe O, Desai P, Morris JC. A Phase Ib Study of the Dual PI3K/mTOR Inhibitor Dactolisib (BEZ235) Combined with Everolimus in Patients with Advanced Solid Malignancies. Target Oncol. 2017 Jun;12(3):323-332. doi: 10.1007/s11523-017-0482-9.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Dactolisib	Small molecule	200 mg	Oral
Subject	Dactolisib	Small molecule	400 mg	Oral
Subject	Dactolisib	Small molecule	800 mg	Oral
Subject	Everolimus	Small molecule	2.5 mg	—