Abstract Details

Title Interim Analysis of a Phase I/II Study of Panobinostat in Combination with Bevacizumab for Recurrent Glioblastoma

Topic Neuro-oncology

Presentation(s) IN10 - (-)

Poster/Presentation
Number 005

Objective

Background Bevacizumab is frequently used to treat recurrent GBM, but responses are not durable. Panobinostat is a histone deacetylase inhibitor with anti-neoplastic and anti-angiogenic effects in GBM and may work synergistically with bevacizumab. We are conducting a multicenter phase II trial of panobinostat in combination with bevacizumab in patients with recurrent GBM.

Design/Methods Patients with recurrent GBM are treated with oral panobinostat 30 mg three times per week, every other week in combination with bevacizumab 10 mg/kg every other week. The primary endpoint is 6-month progression-free survival. An interim analysis will be conducted and accrual suspended if 12 or more of the first 21 patients accrued to the study progress within 6 months of initiating treatment. Patients with recurrent GBM enrolled in the phase I study at the maximum tolerated dose (which is the phase II dose) will be eligible for inclusion in the interim analysis.

Results Twenty of the first 21 patients who meet criteria for inclusion in the interim analysis have been accrued to date. This includes 4 patients enrolled in the phase I study and 16 patients enrolled in the phase II study.

Conclusions Updated interim analysis results will be presented at the meeting.

Authors/Disclosures
Eudocia Q. Lee, MD (Dana Farber Cancer Institute) PRESENTER	No disclosure on file
David Reardon (Center for Neuro-Oncology)	No disclosure on file
David Schiff, MD, FAAN (Univ of VA, Division of Neuro Oncology)	Dr. Schiff has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Orbus Pharmaceutical. Dr. Schiff has received publishing royalties from a publication relating to health care.
Kimford J. Meador, MD, FAAN (Stanford University School of Medicine)	The institution of Dr. Meador has received research support from NIH. The institution of Dr. Meador has received research support from Eisai. The institution of Dr. Meador has received research support from Medtronics. The institution of Dr. Meador has received research support from The Epilepsy Consortium.
Jan Drappatz, MD (University of Pittsburgh Cancer Institute)	Dr. Drappatz has stock in Pfizer. Dr. Drappatz has stock in Vertex. Dr. Drappatz has stock in GSK. The institution of Dr. Drappatz has received research support from Servier. Dr. Drappatz has received publishing royalties from a publication relating to health care.
	No disclosure on file
Sean Grimm, MD (Rush University)	Dr. Grimm has nothing to disclose.
Andrew D. Norden, MD	No disclosure on file
	No disclosure on file
	No disclosure on file
Andrew Chi, MD	No disclosure on file
Tracy T. Batchelor, MD, MPH (Brigham and Women's Hospital)	Dr. Batchelor has received personal compensation in the range of $5,000-$9,999 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for Up To Date, Inc. An immediate family member of Dr. Batchelor has received publishing royalties from a publication relating to health care. Dr. Batchelor has received publishing royalties from a publication relating to health care.
	No disclosure on file
	No disclosure on file
	No disclosure on file
	No disclosure on file
	No disclosure on file
	No disclosure on file
	No disclosure on file
	No disclosure on file
Susan M. Snodgrass, MD (schering-plough corp)	No disclosure on file
Jeffrey J. Raizer, MD	No disclosure on file
Patrick Y. Wen, MD, FAAN (Dana-Farber/Brigham and Women'S Cancer Center)	Dr. Wen has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Astra Zeneca . Dr. Wen has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Black Diamond . Dr. Wen has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Celularity. Dr. Wen has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Chimerix. Dr. Wen has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Day One Bio . Dr. Wen has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Genenta. Dr. Wen has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Glaxo Smith Kline . Dr. Wen has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Merck. Dr. Wen has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Mundipharma. Dr. Wen has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Novartis . Dr. Wen has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Nuvation Bio . Dr. Wen has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Novocure. Dr. Wen has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Prelude Therapeutics . Dr. Wen has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Sagimet. Dr. Wen has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Sapience. Dr. Wen has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Servier. Dr. Wen has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Vascular Biogenics . Dr. Wen has received personal compensation in the range of $500-$4,999 for serving as a Consultant for VBI Vaccines . Dr. Wen has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Astra Zeneca . Dr. Wen has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Black Diamond . Dr. Wen has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Celularity. Dr. Wen has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Chimerix. Dr. Wen has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Day One Bio . Dr. Wen has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Genenta. Dr. Wen has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Glaxo Smith Kline . Dr. Wen has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Merck. Dr. Wen has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Mundipharma. Dr. Wen has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Novartis. Dr. Wen has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Nuvation Bio. Dr. Wen has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Novocure. Dr. Wen has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Prelude Therapeutics. Dr. Wen has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Sagimet. Dr. Wen has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Sapience. Dr. Wen has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Servier. Dr. Wen has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Vascular Biogenics . Dr. Wen has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for VBI Vaccines . Dr. Wen has received research support from Astra Zeneca . Dr. Wen has received research support from Black Diamond . Dr. Wen has received research support from Bristol Meyers Squibb . Dr. Wen has received research support from Celgene. Dr. Wen has received research support from Chimerix. Dr. Wen has received research support from Eli Lily . Dr. Wen has received research support from Erasca. Dr. Wen has received research support from Genentech/Roche . Dr. Wen has received research support from Kazia . Dr. Wen has received research support from MediciNova. Dr. Wen has received research support from Merck. Dr. Wen has received research support from Novartis. Dr. Wen has received research support from Nuvation Bio . Dr. Wen has received research support from Servier. Dr. Wen has received research support from Vascular Biogenics . Dr. Wen has received research support from VBI Vaccines . Dr. Wen has received publishing royalties from a publication relating to health care.

��ɫ��

��ɫ��