Trial · NCT00859222

LBH589 and Bevacizumab in Patients With Recurrent High Grade Glioma

NCT00859222, Phase 1, Phase 2, Completed, Patrick Y. Wen, MD; results first posted 2016-11-28

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. LBH589 and Bevacizumab in Patients With Recurrent High Grade Glioma. Trials, record NCT00859222. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00859222

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: LBH589 and Bevacizumab in Patients With Recurrent High Grade Glioma
NCT number: NCT00859222
Status: Completed
Phases: Phase 1, Phase 2
Enrollment: 51 participants, actual
Lead sponsor: Patrick Y. Wen, MD
Conditions: Malignant Glioma
Interventions: LBH589, bevacizumab
First posted: 2009-03-10
Last updated: 2017-03-14
Results first posted: 2016-11-28

Source ClinicalTrials.gov

Registered outcomes9

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	LBH589 Maximum Tolerated Dose (MTD) [Phase I]	Participants were assessed every 2 weeks while on study; The observation period for MTD evaluation was the first 30 days of treatment.	The MTD LBH589 in combination with bevacizumab 10 mg/kg intravenously (IV) on days 1 and 15 of each 28 day cycle is determined by the number of patients who experience a dose limiting toxicity (DLT). See subsequent primary outcome measure for the DLT definition. The MTD is defined as the highest dose at which fewer than one-third of patients experience a DLT. If no DLTs are observed, the MTD is not reached but the highest dose received may be the Recommended Phase II Dose (RP2D). The MTD was not reached with 0 of 6 DLTs observed in the highest dose cohort but due to safety concerns higher doses of LBH589 with bevacizumab were neither planned nor tested. The RP2D was 30 mg/day orally, 3x per week, every other week.
Primary	Dose Limiting Toxicity (DLT) [Phase I]	Participants were assessed every 2 weeks while on study; The observation period for DLT evaluation was the first 30 days of treatment.	A DLT was defined as an adverse event that (a) is related to the LBH589 and/or bevacizumab with an attribution of possible, probable, or definite, and (b) occurs during and/or begins during the first 30 days of the study treatment, and (c) meets any of the following criteria: grade 3 thrombocytopenia; grade 4 neutropenia lasting 7 days; grade 4 anemia lasting 7 days despite transfusion or growth factors; febrile neutropenia if ANC\<0.5 x10\^9/L; a QT interval corrected for heart rate (QTc) of 500-515 msec that did not stabilize to \<480 msec after one week; a second occurrence of QTc 500-515 msec; any QTc \>515 msec; any deep vein thrombosis (DVT) or pulmonary embolism (PE) while on fully therapeutic anticoagulation therapy; Grade 3 proteinuria lasting 14 days; or any other clinically significant Grade 3 toxicity despite maximal medical therapy lasting 7 days, any Grade 4 toxicity despite maximal medical therapy; or any Grade 3 or 4 toxicity resulting in study drug discontinuation.
Primary	6-Month Progression-Free Survival (PFS6) [Phase II]	Disease was assessed radiographically to document clinical progression every cycle on treatment and post-treatment every 8 weeks up to 12 months. Participants were followed for PFS6 up to 6 months since study entry.	PFS6 is the proportion of patients remaining alive and progression-free at 6-months from study entry. Progressive disease was established based on RANO criteria (Wen et al JCO 2010).
Secondary	Best Radiographic Response	Disease was assessed radiographically for response every cycle on treatment. Treatment duration in cycles was a median (range) of 2 (1-6) PI Cohort 1, 4.5 (2-6) PI Cohort 2, 6 (2-10) PI Cohort 3, 5 PII GBM and 7 PII AG.	Radiographic response was established based on Response Assessment in Neuro-Oncology (RANO) criteria (Wen et al JCO 2010) with 5 potential categories: Complete Response (CR), Partial Response (PR), Stable Disease (SD), Progressive disease (PD) and Unknown status.
Secondary	Progression-Free Survival (PFS) [Phase II]	Disease was assessed radiographically to document clinical progression every cycle on treatment and post-treatment every 8 weeks up to 12 months.	PFS is defined as the time from study entry to the earliest documentation of disease progression or death. Patients alive without evidence of PD were censored at the date of last disease assessment.
Secondary	Overall Survival [Phase II]	Participants were followed long-term for survival every 4 months from the end of treatment until death or lost to follow-up. Phase II participants were followed for OS up to 27 months on this study.	OS is defined as the time from study entry to death or date last known alive.
Other	Progression-Free Survival (PFS) [Phase I]	Disease was assessed radiographically to document clinical progression every cycle on treatment and post-treatment every 8 weeks up to 12 months.	PFS is defined as the time from study entry to the earliest documentation of disease progression or death. Patients alive without evidence of PD were censored at the date of last disease assessment. Progressive disease was established based on Response Assessment in Neuro-Oncology (RANO) criteria (Wen et al JCO 2010).
Other	6-Month Progression-Free Survival (PFS6) [Phase I]	Disease was assessed radiographically to document clinical progression every cycle on treatment and post-treatment every 8 weeks up to 12 months. Participants were followed for PFS6 up to 6 months since study entry.	PFS6 is the proportion of patients remaining alive and progression-free at 6-months from study entry. Progressive disease was established based on Response Assessment in Neuro-Oncology (RANO) criteria (Wen et al JCO 2010).
Other	Overall Survival (OS) [Phase I]	Participants were followed long-term for survival every 4 months from the end of treatment until death or lost to follow-up. Phase I participants were followed for OS up to 12.1 months on this study.	OS is defined as the time from study entry to death or date last known alive.

Source ClinicalTrials.gov

Outcomes9

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	LBH589 Maximum Tolerated Dose (MTD) [Phase I]	Participants were assessed every 2 weeks while on study; The observation period for MTD evaluation was the first 30 days of treatment.	All PI participants who received at least one dose of the study drug were evaluable for MTD.	mg/day orally, 3x per wk, every other wk	NUMBER
PRIMARY	Dose Limiting Toxicity (DLT) [Phase I]	Participants were assessed every 2 weeks while on study; The observation period for DLT evaluation was the first 30 days of treatment.	All PI participants who received at least one dose of the study drug were evaluable for DLT.	participants with DLT	NUMBER
PRIMARY	6-Month Progression-Free Survival (PFS6) [Phase II]	Disease was assessed radiographically to document clinical progression every cycle on treatment and post-treatment every 8 weeks up to 12 months. Participants were followed for PFS6 up to 6 months since study entry.	All participants with measurable disease present at baseline and received at least one dose of the study drug were evaluable for PFS6.	proportion of participants	NUMBER
SECONDARY	Best Radiographic Response	Disease was assessed radiographically for response every cycle on treatment. Treatment duration in cycles was a median (range) of 2 (1-6) PI Cohort 1, 4.5 (2-6) PI Cohort 2, 6 (2-10) PI Cohort 3, 5 PII GBM and 7 PII AG.	All participants with measurable disease present at baseline and received at least one dose of the study drug were evaluable for response.	participants	NUMBER
SECONDARY	Progression-Free Survival (PFS) [Phase II]	Disease was assessed radiographically to document clinical progression every cycle on treatment and post-treatment every 8 weeks up to 12 months.	All PII participants with measurable disease present at baseline and received at least one dose of the study drug were evaluable for PFS.	months	MEDIAN
OTHER_PRE_SPECIFIED	Progression-Free Survival (PFS) [Phase I]	Disease was assessed radiographically to document clinical progression every cycle on treatment and post-treatment every 8 weeks up to 12 months.	All participants with measurable disease present at baseline and received at least one dose of the study drug were evaluable for PFS.	months	MEDIAN
OTHER_PRE_SPECIFIED	6-Month Progression-Free Survival (PFS6) [Phase I]	Disease was assessed radiographically to document clinical progression every cycle on treatment and post-treatment every 8 weeks up to 12 months. Participants were followed for PFS6 up to 6 months since study entry.	All participants with measurable disease present at baseline and received at least one dose of the study drug were evaluable for PFS6.	proportion of participants	NUMBER
SECONDARY	Overall Survival [Phase II]	Participants were followed long-term for survival every 4 months from the end of treatment until death or lost to follow-up. Phase II participants were followed for OS up to 27 months on this study.	All participants who received at least one dose of the study drug were followed for OS.	months	MEDIAN
OTHER_PRE_SPECIFIED	Overall Survival (OS) [Phase I]	Participants were followed long-term for survival every 4 months from the end of treatment until death or lost to follow-up. Phase I participants were followed for OS up to 12.1 months on this study.	All participants who received at least one dose of the study drug were followed for OS.	months	MEDIAN

Source ClinicalTrials.gov

Results by group33

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
LBH589 Maximum Tolerated Dose (MTD) [Phase I]	All Phase I Participants		30		mg/day orally, 3x per wk, every other wk
Dose Limiting Toxicity (DLT) [Phase I]	Phase I Cohort 1: Bevacizumab +LBH589 20 mg Every Week		1		participants with DLT
Dose Limiting Toxicity (DLT) [Phase I]	Phase I Cohort 2: Bevacizumab + LBH589 20 mg Every Other Week		0		participants with DLT
Dose Limiting Toxicity (DLT) [Phase I]	Phase I Cohort 3: Bevacizumab + LBH589 30 mg Every Other Week		0		participants with DLT
6-Month Progression-Free Survival (PFS6) [Phase II]	Phase II GBM: Bevacizumab + LBH589 30 mg Every Other Week		0.304	95% Confidence Interval 0.124 to 0.507	proportion of participants
6-Month Progression-Free Survival (PFS6) [Phase II]	Phase II AG: Bevacizumab + LBH589 30 mg Every Other Week		0.467	95% Confidence Interval 0.21 to 0.73	proportion of participants
Best Radiographic Response	Phase I Cohort 1: Bevacizumab +LBH589 20 mg Every Week	Complete Response	0		participants
Best Radiographic Response	Phase I Cohort 2: Bevacizumab + LBH589 20 mg Every Other Week	Complete Response	0		participants
Best Radiographic Response	Phase I Cohort 3: Bevacizumab + LBH589 30 mg Every Other Week	Complete Response	0		participants
Best Radiographic Response	Phase II GBM: Bevacizumab + LBH589 30 mg Every Other Week	Complete Response	0		participants

1 to 10 of 33Source ClinicalTrials.gov

See all 33 results by group

Participant flow15

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Phase I Cohort 1: Bevacizumab +LBH589 20 mg Every Week	3
Overall Study	STARTED	Phase I Cohort 2: Bevacizumab + LBH589 20 mg Every Other Week	3
Overall Study	STARTED	Phase I Cohort 3: Bevacizumab + LBH589 30 mg Every Other Week	6
Overall Study	STARTED	Phase II GBM: Bevacizumab + LBH589 30 mg Every Other Week	24
Overall Study	STARTED	Phase II AG: Bevacizumab + LBH589 30 mg Every Other Week	15
Overall Study	COMPLETED	Phase I Cohort 1: Bevacizumab +LBH589 20 mg Every Week	0
Overall Study	COMPLETED	Phase I Cohort 2: Bevacizumab + LBH589 20 mg Every Other Week	0
Overall Study	COMPLETED	Phase I Cohort 3: Bevacizumab + LBH589 30 mg Every Other Week	0
Overall Study	COMPLETED	Phase II GBM: Bevacizumab + LBH589 30 mg Every Other Week	0
Overall Study	COMPLETED	Phase II AG: Bevacizumab + LBH589 30 mg Every Other Week	0

1 to 10 of 15Source ClinicalTrials.gov

See all 15 participant flow

Adverse events530

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Abdomen, pain	Gastrointestinal disorders	Phase I Cohort 1: Bevacizumab +LBH589 20 mg Every Week	0	3
other	Abdomen, pain	Gastrointestinal disorders	Phase I Cohort 2: Bevacizumab + LBH589 20 mg Every Other Week	0	3
other	Abdomen, pain	Gastrointestinal disorders	Phase I Cohort 3: Bevacizumab + LBH589 30 mg Every Other Week	0	6
other	Abdomen, pain	Gastrointestinal disorders	Phase II GBM: Bevacizumab + LBH589 30 mg Every Other Week	0	24
other	Abdomen, pain	Gastrointestinal disorders	Phase II AG: Bevacizumab + LBH589 30 mg Every Other Week	2	15
other	Alkaline phosphatase	Investigations	Phase I Cohort 1: Bevacizumab +LBH589 20 mg Every Week	1	3
other	Alkaline phosphatase	Investigations	Phase I Cohort 2: Bevacizumab + LBH589 20 mg Every Other Week	0	3
other	Alkaline phosphatase	Investigations	Phase I Cohort 3: Bevacizumab + LBH589 30 mg Every Other Week	1	6
other	Alkaline phosphatase	Investigations	Phase II GBM: Bevacizumab + LBH589 30 mg Every Other Week	1	24
other	Alkaline phosphatase	Investigations	Phase II AG: Bevacizumab + LBH589 30 mg Every Other Week	1	15

1 to 10 of 530Source ClinicalTrials.gov

See all 530 adverse events

Adverse event totals15

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Phase I Cohort 1: Bevacizumab +LBH589 20 mg Every Week
Total, all-cause mortality	Phase I Cohort 2: Bevacizumab + LBH589 20 mg Every Other Week
Total, all-cause mortality	Phase I Cohort 3: Bevacizumab + LBH589 30 mg Every Other Week
Total, all-cause mortality	Phase II GBM: Bevacizumab + LBH589 30 mg Every Other Week
Total, all-cause mortality	Phase II AG: Bevacizumab + LBH589 30 mg Every Other Week
Total, other adverse events	Phase I Cohort 1: Bevacizumab +LBH589 20 mg Every Week	3	3
Total, other adverse events	Phase I Cohort 2: Bevacizumab + LBH589 20 mg Every Other Week	3	3
Total, other adverse events	Phase I Cohort 3: Bevacizumab + LBH589 30 mg Every Other Week	6	6
Total, other adverse events	Phase II GBM: Bevacizumab + LBH589 30 mg Every Other Week	21	24
Total, other adverse events	Phase II AG: Bevacizumab + LBH589 30 mg Every Other Week	15	15

1 to 10 of 15Source ClinicalTrials.gov

See all 15 adverse event totals

Papers2

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
21984064	RESULT	PubMed
25572329	RESULT	PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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