A Phase 1b/2 Study of PLX3397 + Radiation Therapy + Temozolomide in Patients With Newly Diagnosed Glioblastoma

Summary

The study objectives are to assess the potential for PLX3397 to improve the efficacy of standard of care radiation therapy (RT) + temozolomide in patients with newly diagnosed glioblastoma (GBM).

Timeline

Start

2013-07-18

Primary completion

2017-11-03

Completion

2020-03-04

Outcome

Missed primary endpoint

registry analysis (other test); RP2D vs RP2D-0525 (Cycle 1, Day 1); p = 0.456; Hazard Ratio (HR) 0.98 (95% CI 0.71 to 1.36); Log Rank NCT01790503 ↗

registry analysis (other test); RP2D vs RP2D-0825; p = 0.619; Hazard Ratio (HR) 1.05 (95% CI 0.77 to 1.43); Log Rank NCT01790503 ↗

registry analysis (other test); RP2D vs RP2D-0525 (Rest Period, Day 15); p = 0.272; Hazard Ratio (HR) 0.90 (95% CI 0.65 to 1.26); Log Rank NCT01790503 ↗

Publications

• Results Gilbert MR, Wang M, Aldape KD, Stupp R, Hegi ME, Jaeckle KA, Armstrong TS, Wefel JS, Won M, Blumenthal DT, Mahajan A, Schultz CJ, Erridge S, Baumert B, Hopkins KI, Tzuk-Shina T, Brown PD, Chakravarti A, Curran WJ Jr, Mehta MP. Dose-dense temozolomide for newly diagnosed glioblastoma: a randomized phase III clinical trial. J Clin Oncol. 2013 Nov 10;31(32):4085-91. doi: 10.1200/JCO.2013.49.6968. Epub 2013 Oct 7.
• Results Gilbert MR, Dignam JJ, Armstrong TS, Wefel JS, Blumenthal DT, Vogelbaum MA, Colman H, Chakravarti A, Pugh S, Won M, Jeraj R, Brown PD, Jaeckle KA, Schiff D, Stieber VW, Brachman DG, Werner-Wasik M, Tremont-Lukats IW, Sulman EP, Aldape KD, Curran WJ Jr, Mehta MP. A randomized trial of bevacizumab for newly diagnosed glioblastoma. N Engl J Med. 2014 Feb 20;370(8):699-708. doi: 10.1056/NEJMoa1308573.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Pexidartinib	Small molecule	600 mg	Oral
Subject	Pexidartinib	Small molecule	800 mg	Oral
Subject	Pexidartinib	Small molecule	1000 mg	Oral
Background	Temozolomide	Small molecule	—	Oral

Indications