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Histone Deacetylase Inhibitor

Entinostat for Kidney Cancer

Phase 2

Waitlist Available

Led By Roberto Pili, MD

Research Sponsored by Roberto Pili

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 24 months

Awards & highlights

Study Summary

This trial is testing a new combination of drugs to treat kidney cancer that has progressed despite other treatments. The first part of the trial establishes a safe dosage, then subjects are treated with the combination of drugs. The trial assesses the anti-tumor activity every 6 weeks.

Eligible Conditions

Kidney Cancer

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Establish the recommended Phase II dose (RP2D)

Objective Response Rate (ORR) via RECIST 1.1

Secondary outcome measures

Assess Adverse Events

ORR via irRC

Overall Survival (OS)

+2 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

Hyponatremia

Early satiety

Colitis

Pneumonia

Transaminitis

Anemia

Hypothyroidism

Fever

Flu-like symptoms

Neutrophil count decreased

Lymphocyte count decreased

White blood cell decreased

Dry lips

Aspartate aminotransferase increased

Dizziness

Insomnia

Pruritus

100%

80%

60%

40%

20%

Study treatment Arm

Arm A - Cholangiocarcinoma

ARM B - Pancreatic Cancer

Trial Design

1Treatment groups

Experimental Treatment

Group I: Entinostat, Nivolumab and IpilimumabExperimental Treatment3 Interventions

Entinostat: 5mg, 3mg, or 2mg orally (PO) on D1, 8, 15 plus Nivolumab: 3 mg/kg IV D1 and Ipilimumab 1 mg/kg IV D1 Each cycle is 21 days

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Entinostat

2017

Completed Phase 2

~1170

Nivolumab

2014

Completed Phase 3

~4750

Ipilimumab

2014

Completed Phase 3

~2620

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Roberto PiliLead Sponsor

2 Previous Clinical Trials

118 Total Patients Enrolled

Bristol-Myers SquibbIndustry Sponsor

2,638 Previous Clinical Trials

4,128,496 Total Patients Enrolled

Syndax PharmaceuticalsIndustry Sponsor

48 Previous Clinical Trials

2,756 Total Patients Enrolled

Frequently Asked Questions

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

Is Entinostat a viable option for patients with no significant risks?

"Our experts at Power assigned a score of 2 to Entinostat, as Phase 2 trials have provided some safety evidence but no efficacy data yet."

Answered by AI

Are there any opportunities for enrollment in this research initiative?

"At this time, no new volunteers are being sought for the trial posted on August 31st 2018. However, those interested may find 2582 clinical trials with renal cell carcinoma and 779 studies involving Entinostat that are currently accepting enrollees."

Answered by AI

Could you kindly outline any additional experiments done regarding Entinostat?

"In 2009, entinostat was first utilized in clinical studies at Texas Children's Hospital. There are currently 779 registered trials which involve the use of this drug, and 395 have been completed to date. A considerable amount of these research efforts take place within Washington D.C."

Answered by AI

What maladies has Entinostat been proven to alleviate?

"Entinostat is a viable treatment option for individuals who have had prior anti-angiogenic therapy, unresectable malignant neoplasms, and melanoma."

Answered by AI

What are the main aims of this clinical experiment?

"This 6-month clinical trial aims to measure the Objective Response Rate (ORR) via RECIST 1.1 and two secondary outcomes: ORR via irRC, Progression Free Survival (PFS) per irRC, and Overall Survival (OS). Specifically, ORR is defined as the rate of complete response plus partial response; PFS is measured from day one of treatment until disease progression or death; OS commences on Day One of administration and terminates when mortality occurs for any reason."

Answered by AI

What is the current capacity for participants in this clinical experiment?

"Currently, this research is no longer looking for participants. It was posted on August 31st 2018 and edited January 10th 2022. Fortunately, if you are seeking other studies related to renal cell carcinoma there 2582 trials recruiting right now and 779 clinicals currently searching for Entinostat patients."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Study of Entinostat With Nivolumab Plus Ipilimumab in Previously Treated Renal Cell Carcinoma

Roberto Pili 2018. "Study of Entinostat With Nivolumab Plus Ipilimumab in Previously Treated Renal Cell Carcinoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03552380.

All > Renal Cell Carcinoma