Page last updated: 2024-10-31

entinostat and Disease Exacerbation

entinostat has been researched along with Disease Exacerbation in 3 studies

Research Excerpts

Excerpt	Relevance	Reference
"Cancer cachexia is mainly characterized by wasting of skeletal muscles and fat and body weight loss, along with severe complications of major organs like liver, heart, brain and bone."	1.72	Systemic study of selected histone deacetylase inhibitors in cardiac complications associated with cancer cachexia. ( Bora, V; Goyal, RK; Johar, K; Patel, BM; Patel, D, 2022)

Research

Studies (3)

Timeframe	Studies, this research(%)	All Research%
pre-1990	0 (0.00)	18.7374
1990's	0 (0.00)	18.2507
2000's	0 (0.00)	29.6817
2010's	2 (66.67)	24.3611
2020's	1 (33.33)	2.80

Authors

Authors	Studies
Bora, V	1
Patel, D	1
Johar, K	1
Goyal, RK	1
Patel, BM	1
Carter, CA	1
Zeman, K	1
Day, RM	1
Richard, P	1
Oronsky, A	1
Oronsky, N	1
Lybeck, M	1
Scicinski, J	1
Oronsky, B	1
Juergens, RA	1
Wrangle, J	1
Vendetti, FP	1
Murphy, SC	1
Zhao, M	1
Coleman, B	1
Sebree, R	1
Rodgers, K	1
Hooker, CM	1
Franco, N	1
Lee, B	1
Tsai, S	1
Delgado, IE	1
Rudek, MA	1
Belinsky, SA	1
Herman, JG	1
Baylin, SB	1
Brock, MV	1
Rudin, CM	1

Clinical Trials (2)

Trial Overview

Trial	Phase	Enrollment	Study Type	Start Date	Status
A Phase I/II Study of Entinostat in Combination With 5-Azacytidine in Patients With Recurrent Advanced Non-Small Cell Lung Cancer[NCT00387465]	Phase 1/Phase 2	94 participants (Actual)	Interventional	2006-08-31	Completed
Phase 1b/2a Safety and Immunogenicity of the DNMT Inhibitor Azacitidine During Anti-Tuberculosis Therapy[NCT03941496]	Phase 1/Phase 2	0 participants (Actual)	Interventional	2022-10-31	Withdrawn (stopped due to The study was halted prematurely due to Bristol-Myers Squibb's (BMS) decision to withdraw support for this study.)
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Trial Outcomes

(Phase I) Maximum Tolerated Dose (MTD) of Azacitidine When Given Together With Entinostat as Determined by Number of Participants Experiencing Dose-limiting Toxicity (DLT)

DLT is defined by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v3.0 (NCT00387465)
Timeframe: Up to 28 days

Intervention	Participants (Count of Participants)
Phase I - 30mg/m2 Azacitidine	0
Phase I - 40mg/m2 Azacitidine	0

Effect of Entinostat and Azacitidine on DNA Methylation and Response

"Number of participants with decrease in DNA methylation (methylation-signature positive) on Day 10 or Day 29, and either stable disease or objective response (OR) as defined by RECIST 1.0. Per RECIST 1.0, progression is defined as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions; PR is defined as >=30% decrease in the sum of the longest diameter of target lesions, complete response is defined as disappearance of all target lesions; OR=CR+PR." (NCT00387465)
Timeframe: Baseline and days 10 and 29

Intervention	Participants (Count of Participants)
Azacitidine 40mg/m2 With Entinostat	8

Overall Survival

Determined by the method determined by Kaplan and Meier. 95% confidence intervals will be estimated. (NCT00387465)
Timeframe: Up to 1 year

Intervention	months (Median)
Azacitidine 40mg/m2 With Entinostat	6.4

Pharmacokinetic Profile of Azacitidine as Measured by AUC (ng*hr/mL)

(NCT00387465)
Timeframe: Day 1

Intervention	ng*hr/mL (Mean)
Azacitidine 40mg/m2 With Entinostat	675

Pharmacokinetic Profile of Azacitidine as Measured by Cmax

Maximal concentration (ng/mL) of azacitidine (NCT00387465)
Timeframe: Day 1

Intervention	ng/mL (Mean)
Azacitidine 40mg/m2 With Entinostat	468

Pharmacokinetic Profile of Azacitidine as Measured by Half-life

(NCT00387465)
Timeframe: Day 1

Intervention	hours (Mean)
Azacitidine 40mg/m2 With Entinostat	1.12

Pharmacokinetic Profile of Azacytidine as Measured by Tmax

Time to maximal concentration of azacitidine in the blood. (NCT00387465)
Timeframe: Day 1

Intervention	hours (Median)
Azacitidine 40mg/m2 With Entinostat	0.5

Progression-free Survival

Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. Determined by the method determined by Kaplan and Meier. 95% confidence intervals will be estimated. (NCT00387465)
Timeframe: Up to 1 year

Intervention	weeks (Median)
Azacitidine 40mg/m2 With Entinostat	7.4

Average Steady State Trough Concentration (ng/mL) of Entinostat

(NCT00387465)
Timeframe: Day 10 and 17

Intervention	ng/mL (Mean)
	Day 10	Day 17
Azacitidine 40mg/m2 With Entinostat	0.84	1.10

Reviews

1 review available for entinostat and Disease Exacerbation

Article	Year
Addressing the elephant in the room, therapeutic resistance in non-small cell lung cancer, with epigenetic therapies. Oncotarget, 2016, Jun-28, Volume: 7, Issue:26 Topics: Antibodies, Monoclonal; Azacitidine; Azetidines; Benzamides; Biomarkers, Tumor; Carcinoma, Non-Small	2016

Trials

1 trial available for entinostat and Disease Exacerbation

Article	Year
Combination epigenetic therapy has efficacy in patients with refractory advanced non-small cell lung cancer. Cancer discovery, 2011, Volume: 1, Issue:7 Topics: Aged; Aged, 80 and over; Antineoplastic Combined Chemotherapy Protocols; Azacitidine; Benzamides; Bi	2011
Combination epigenetic therapy has efficacy in patients with refractory advanced non-small cell lung cancer. Cancer discovery, 2011, Volume: 1, Issue:7 Topics: Aged; Aged, 80 and over; Antineoplastic Combined Chemotherapy Protocols; Azacitidine; Benzamides; Bi	2011
Combination epigenetic therapy has efficacy in patients with refractory advanced non-small cell lung cancer. Cancer discovery, 2011, Volume: 1, Issue:7 Topics: Aged; Aged, 80 and over; Antineoplastic Combined Chemotherapy Protocols; Azacitidine; Benzamides; Bi	2011
Combination epigenetic therapy has efficacy in patients with refractory advanced non-small cell lung cancer. Cancer discovery, 2011, Volume: 1, Issue:7 Topics: Aged; Aged, 80 and over; Antineoplastic Combined Chemotherapy Protocols; Azacitidine; Benzamides; Bi	2011

Other Studies

1 other study available for entinostat and Disease Exacerbation

Article	Year
Systemic study of selected histone deacetylase inhibitors in cardiac complications associated with cancer cachexia. Canadian journal of physiology and pharmacology, 2022, Volume: 100, Issue:3 Topics: Animals; Benzamides; Butyric Acid; Cachexia; Cell Line, Tumor; Disease Models, Animal; Disease Progr	2022