A Study of PD 0332991 in Patients With Recurrent Rb Positive Glioblastoma

Phase 2 Terminated 23 enrolled University of California, San Francisco Pfizer · collab

Non-randomizedParallel-groupOpen-labelTreatment

Summary

This study will determine the efficacy of the small molecule CDK4/6 inhibitor PD 0332991 (as measured by progression free survival at 6 months) in patients with recurrent glioblastoma multiforme or gliosarcoma who are Rb positive. A total of 30 patients will be treated; 15 will undergo a planned surgical resection and receive drug for 7 days prior to surgery, followed by drug after recovery from surgery, and the other 15 patients will receive drug without a planned surgical procedure.

Timeline

Start: 2010-09
Primary completion: 2013-12
Completion: 2013-12

Outcome

Missed primary endpoint

paper Trial was stopped early secondary to lack of efficacy, with 95% of evaluable patients progressing within 6 months. PMID 30151703 ↗

Publications

Taylor JW, Parikh M, Phillips JJ, James CD, Molinaro AM, Butowski NA, Clarke JL, Oberheim-Bush NA, Chang SM, Berger MS, Prados M. Phase-2 trial of palbociclib in adult patients with recurrent RB1-positive glioblastoma. J Neurooncol. 2018 Nov;140(2):477-483. doi: 10.1007/s11060-018-2977-3. Epub 2018 Aug 27.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Palbociclib	Small molecule	125 mg	Oral