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Histone Deacetylase Inhibitor

Entinostat for Myelodysplastic Syndrome

Phase 1
Waitlist Available
Led By Amer M Zeidan
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from start of study to death, assessed for up to 2 years
Awards & highlights

Study Summary

This trial is testing entinostat + pembrolizumab to see if it's effective & has manageable side effects in treating patients with myelodysplastic syndrome who have failed DNMTi therapy.

Who is the study for?
This trial is for adults with Myelodysplastic Syndrome or Preleukemia who haven't improved after treatment with hypomethylating agents. They should have proper kidney and liver function, no severe illnesses, and not be pregnant or breastfeeding. HIV-positive patients can join if they meet certain health criteria.Check my eligibility
What is being tested?
The trial tests the combination of Pembrolizumab (an immune system booster) and Entinostat (a growth blocker for cancer cells) in patients whose previous DNA methyltransferase inhibitor therapy didn't work. It aims to find the safest dose and see how well these drugs work together.See study design
What are the potential side effects?
Possible side effects include reactions related to boosting the immune system which might cause inflammation in various organs, infusion-related reactions, fatigue, changes in blood counts, infections risk increase, as well as potential unknown risks to unborn children.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from start of study to death, assessed for up to 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and from start of study to death, assessed for up to 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Maximum tolerated dose of entinostat given in combination with pembrolizumab
Secondary outcome measures
Median progression-free survival
Overall response rate (complete response [CR], partial response [PR], hematologic improvement [HI])
Other outcome measures
1-year overall survival
2-year overall survival
Dynamic quantitative change in proportion of myeloid-derived suppressor cells (MDSCs) in bone marrow with combined therapy, assessed by flow cytometry
+3 more

Side effects data

From 2020 Phase 2 trial • 44 Patients • NCT03250273
92%
Fatigue
46%
Nausea
38%
Anorexia
31%
Edema
23%
Platelet count decreased
23%
Rash maculo-papular
15%
Pneumonitis
15%
Thrush
15%
Constipation
15%
Diarrhea
15%
Dysgeusia
8%
Hyponatremia
8%
Early satiety
8%
Colitis
8%
Pneumonia
8%
Transaminitis
8%
Anemia
8%
Hypothyroidism
8%
Fever
8%
Flu-like symptoms
8%
Neutrophil count decreased
8%
Lymphocyte count decreased
8%
White blood cell decreased
8%
Dry lips
8%
Aspartate aminotransferase increased
8%
Dizziness
8%
Insomnia
8%
Pruritus
100%
80%
60%
40%
20%
0%
Study treatment Arm
Arm A - Cholangiocarcinoma
ARM B - Pancreatic Cancer

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (entinostat, pembrolizumab)Experimental Treatment2 Interventions
Patients receive lower dose entinostat PO on days 1 and 8 or higher dose entinostat PO on days 1, 8, and 15, and pembrolizumab IV over 30 minutes on day 1 of cycle 2 and cycles thereafter. Treatment repeats every 21 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Patients who achieve an objective response or maintain a SD status after the first 4 cycles may continue to receive entinostat and pembrolizumab for up to 1 year.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Entinostat
2017
Completed Phase 2
~1170
Pembrolizumab
2017
Completed Phase 2
~2010

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,654 Previous Clinical Trials
40,933,125 Total Patients Enrolled
Amer M ZeidanPrincipal InvestigatorYale University Cancer Center LAO
2 Previous Clinical Trials
200 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the current enrolment for this research project?

"This research is no longer enrolling; it was initially posted on April 3rd, 2017 and most recently updated November 12th 2022. Currently, there are 1596 muscular dystrophy trials that require participants as well as 974 Entinostat studies searching for enrollees."

Answered by AI

Is Entinostat a viable option from a safety perspective for patients?

"At Power, we appraised the safety of Entinostat as a 1 because it is only in its initial phase. Consequently, there are scant findings regarding efficacy and security."

Answered by AI

To what conditions is Entinostat generally prescribed?

"Entinostat is regularly employed to combat malignant neoplasms and can also be used in the treatment of unresectable melanoma, microsatellite instability high, and cancer that has progressed despite chemotherapy."

Answered by AI

In what geographic areas is this scientific experiment being conducted?

"19 clinical trial sites are involved in the study, with locations such as University of Kansas Clinical Research Center in Fairway, UT Southwestern/Simmons Cancer Center-Dallas in Dallas and Rutgers Cancer Institute of New jersey in New Brunswick. Additionally, there are 16 other medical centres providing their services for this investigation."

Answered by AI

Is it still possible for people to join this research endeavour?

"This research project has concluded its recruitment phase, having been initially posted on April 3rd 2017 and last updated November 12th 2022. If you are looking for alternative studies, there are currently 1596 trials recruiting patients affected by muscular dystrophy and 974 clinical investigations accepting participants with entinostat."

Answered by AI

Could you provide additional insights into the trials that have recently been conducted using Entinostat?

"Presently, there are 974 clinical trials underway that investigate Entinostat. Of those studies, 124 have reached Phase 3. A large concentration of these tests is found in Houston, Texas but investigation for this drug spans over 36 thousand different locations globally."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Testing the Safety and Efficacy of the Combination of the Antibody Pembrolizumab and Entinostat in Patients With Myelodysplastic Syndrome Who Are Not Responding to Hypomethylating Agents
2017. "Testing the Safety and Efficacy of the Combination of the Antibody Pembrolizumab and Entinostat in Patients With Myelodysplastic Syndrome Who Are Not Responding to Hypomethylating Agents". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02936752.
~4 spots leftby Apr 2025
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