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Histone Deacetylase Inhibitor
entinostat for Colorectal Cancer
Phase 1 & 2
Waitlist Available
Led By Passi A Janne, MD, PhD
Research Sponsored by Syndax Pharmaceuticals
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 at 6 months of treatment for each of the 3 dose escalation (ph 2 cohorts) as applicable
Awards & highlights
Study Summary
This trial will test the safety and effectiveness of combining entinostat with pembrolizumab to treat patients with non-small cell lung cancer, melanoma, or mismatch-repair proficient colorectal cancer.
Eligible Conditions
- Colorectal Cancer
- Non-Small Cell Lung Cancer
- Melanoma
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at 6 months of treatment for each of the 3 dose escalation (ph 2 cohorts) as applicable
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 6 months of treatment for each of the 3 dose escalation (ph 2 cohorts) as applicable
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of Participants taking 3mg entinostat weekly with Adverse Events as a Measure of Safety and Tolerability
Number of Participants taking 5mg entinostat weekly with Adverse Events as a Measure of Safety and Tolerability
Overall Response Rate using irRECIST for Phase 2 Dose and Schedule for Cohort 1 Stage 1 (NSCLC)
+5 moreSecondary outcome measures
Clinical Benefit Rate (CBR)
Duration of Response (DOR)
Overall survival (OS)
+3 moreSide effects data
From 2011 Phase 2 trial • 24 Patients • NCT0046260521%
Neutropenic infection
13%
Bone Pain
8%
confusion
8%
Fatigue
8%
hyponatremia
8%
hypoxia
8%
Muscle weakness
4%
back pain
4%
Weakness
4%
fatigue
4%
hypocalcemia
4%
Dyspnea
4%
GI bleed
4%
vasovagal episode
4%
cough
4%
Pericardial effusion
4%
anorexia
4%
Joint pain
4%
pneumonitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Arm I
Trial Design
4Treatment groups
Experimental Treatment
Group I: Ph 2 NSCLC pre-treated PD-1/LD-L1Experimental Treatment2 Interventions
Cohort 2: Patients with NSCLC (any histology) who have previously been treated with and unequivocally progressed on either a PD-1 or PD-L1-blocking antibody (entinostat + pembrolizumab)
Group II: Ph 2 NSCLC (squamous or adeno)Experimental Treatment2 Interventions
Cohort 1: Patients with Non-Small Cell Lung Cancer, with squamous cell or adenocarcinoma histology who have not been treated with a PD-1 or PD-L-1 blocking antibody (entinostat + pembrolizumab)
Group III: Ph 2 Mismatch Repair-Proficient CRCExperimental Treatment2 Interventions
Cohort 4: Patients with CRC (mismatch repair-proficient) who have not been previously treated with a PD-1 or PD-L1 blocking antibody
Group IV: Ph 2 Melanoma pre-treated PD-1/PD-L1Experimental Treatment2 Interventions
Cohort 3: Patients with melanoma who have previously been treated with and unequivocally progressed on either a PD-1 or PD-L1-blocking antibody (entinostat + pembrolizumab)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
entinostat
2008
Completed Phase 2
~750
pembrolizumab
2018
Completed Phase 3
~6240
Find a Location
Who is running the clinical trial?
Syndax PharmaceuticalsLead Sponsor
48 Previous Clinical Trials
2,605 Total Patients Enrolled
Merck Sharp & Dohme LLCIndustry Sponsor
3,862 Previous Clinical Trials
5,049,504 Total Patients Enrolled
Passi A Janne, MD, PhDPrincipal InvestigatorDana-Farber Cancer Institute
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