To Determine the Maximum Tolerated Dose of Oral CEP-37440 in Patients With Advanced or Metastatic Solid Tumors

NCT01922752 ↗

Phase 1 Completed 32 enrolled Teva Branded Pharmaceutical Products R&D, Inc.

NaSingle-groupOpen-labelTreatment

Summary

The primary objective is to determine the maximum tolerated dose (MTD), safety, and tolerability of oral CEP-37440 administered daily to patients with advanced or metastatic solid tumors.

Timeline

Start: 2013-07
Primary completion: 2015-09
Completion: 2015-12

Publications

Schilder RJ, Rasco D, Sharma MR. An open-label study to determine the maximum tolerated dose of oral ESK-440 administered as a single agent in patients with advanced or metastatic solid tumors. Neoplasia. 2025 Mar;61:101133. doi: 10.1016/j.neo.2025.101133. Epub 2025 Feb 5.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	CEP-37440	Small molecule	25 mg	Oral
Subject	CEP-37440	Small molecule	500 mg	Oral
Subject	CEP-37440	Small molecule	700 mg	Oral

To Determine the Maximum Tolerated Dose of Oral CEP-37440 in Patients With Advanced or Metastatic Solid Tumors

Summary

Timeline

Publications

Drugs

Indications