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HDAC Inhibitor
Entinostat + ZEN003694 for Cancer
Phase 1 & 2
Recruiting
Led By Patricia M LoRusso
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
Patients with lymphoma should have received at least two previous therapies with at least one combination chemotherapy regimen for metastatic disease
Eastern Cooperative Oncology Group (ECOG) performance status =< 2 (Karnofsky >= 60%)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 28 days
Awards & highlights
Study Summary
This trial is testing a combination of two drugs, entinostat and ZEN003694, to see if they are safe and effective in treating patients with advanced or refractory solid tumors or lymphoma.
Who is the study for?
Adults with advanced or treatment-resistant solid tumors or lymphoma, who have tried standard treatments without success. They must be in good enough health as shown by specific blood tests and organ function measures, not pregnant, able to take oral medication, and free of certain other medical conditions.Check my eligibility
What is being tested?
The trial is testing the combination of two drugs: Entinostat (an enzyme blocker) and ZEN003694 (a protein inhibitor), for patients whose cancer has spread or doesn't respond to treatment. It's a phase I/II trial aimed at finding the safest dose with the fewest side effects.See study design
What are the potential side effects?
Potential side effects include reactions related to immune system suppression since both drugs target enzymes and proteins crucial for cell growth. This can lead to increased risk of infections, possible liver issues, fatigue, nausea, vomiting, and potential bleeding problems.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have lymphoma and have undergone at least two treatments, including chemotherapy.
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I can take care of myself but might not be able to do active work.
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I have had at least one standard treatment for my cancer since it spread.
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My kidney function is good, with a GFR of 60 mL/min/1.73 m^2 or higher.
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My solid tumor can be measured using specific criteria.
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I can swallow and keep down pills.
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I am 18 years old or older.
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I have lymphoma and have either tried all curative treatments or refused them.
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I had hepatitis C but have been treated and cured.
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My heart condition does not severely limit my daily activities.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 28 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 28 days
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 (MTD) (Phase Ib)
Objective response rate (ORR) (Phase II)
Recommended phase 2 dose (RP2D) (Phase Ib)
Secondary outcome measures
Duration of response
Overall survival
Progression free survival
+1 moreOther outcome measures
Non-sequencing biomarker analysis
Whole-exome sequencing analysis
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (entinostat, ZEN003694)Experimental Treatment3 Interventions
PHASE I RUN-IN PERIOD: Patients receive ZEN003694 PO QD during days -14 to 1. Patients also undergo core needle biopsy within 30 days prior to starting therapy.
PHASE II RUN-IN PERIOD: Patients receive ZEN003694 PO QD or entinostat PO QW during days -14 to 1 based on the order to which they are enrolled to the study (e.g. every other patient starts by taking ZEN003694 alone for 14 days). Patients also undergo core needle biopsy within 30 days prior to starting therapy.
PHASE I & II COMBINATION TREATMENT: Patients receive entinostat PO QW on days 1, 8, 15, and 22, and ZEN003694 PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo core needle biopsy on day 1 of cycle 1, and on day 1 of cycle 14.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Core Biopsy
2013
N/A
~130
Entinostat
2017
Completed Phase 2
~1170
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,661 Previous Clinical Trials
40,924,392 Total Patients Enrolled
Patricia M LoRussoPrincipal InvestigatorYale University Cancer Center LAO
5 Previous Clinical Trials
312 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't had significant bleeding or bleeding disorders in the last 6 months.Your bilirubin levels are within a certain limit as measured in a recent test.I have lymphoma and have undergone at least two treatments, including chemotherapy.I have had radiation therapy within the last 21 days.I haven't had major surgery, except for diagnosis, dental work, or stenting, in the last 4 weeks.I have not been treated with ZEN003694, HDAC inhibitors, or BET inhibitors.You have had allergic reactions to drugs similar to entinostat or ZEN003694.I have been diagnosed with NK cell lymphoma.I have recovered from previous cancer treatment side effects, except for hair loss or stable long-term mild effects.I am not taking any strong medication that affects liver enzymes.I have received radiation to more than a quarter of my bone marrow.I have someone legally authorized to make decisions for me if I'm unable to.I can take care of myself but might not be able to do active work.I have severe nausea or issues absorbing food that could affect taking pills.Your liver enzymes (AST/ALT) should not be more than 2.5 times the normal level. This will be checked within 14 days before starting the study treatment.I have an advanced or hard-to-treat cancer that needs standard treatment.Your troponin level is within the normal range when measured within 14 days before starting the study treatment.Your white blood cell count needs to be at least 1,500 per microliter.I have had at least one standard treatment for my cancer since it spread.I haven't had bone-targeted radionuclide therapy in the last 6 weeks.My kidney function is good, with a GFR of 60 mL/min/1.73 m^2 or higher.My solid tumor can be measured using specific criteria.Your kidneys are working well enough to filter out waste from your blood.My pancreatic cancer cannot be removed by surgery and does not respond to standard treatments.For patients with lymphoma, they must have a way to measure their disease based on specific medical criteria.I can swallow and keep down pills.I am 18 years old or older.I have lymphoma and have either tried all curative treatments or refused them.Your platelet count is at least 100,000 per microliter.Your hemoglobin level is at least 9.0 grams per deciliter within 14 days before starting the study treatment.Your blood clotting test results should not be more than 1.5 times the upper limit of normal.I am a woman who can have children and have a recent negative pregnancy test.My brain scans show no cancer growth after treatment for brain metastases.I have another cancer, but it won't affect this trial's treatment.I had hepatitis C but have been treated and cured.My heart condition does not severely limit my daily activities.Your albumin level is higher than 2.5 grams per deciliter, as measured within 14 days before starting the study treatment.I have a heart condition.You are currently taking any other experimental medications.I haven't had any cancer treatment in the last 14 days or 5 half-lives, whichever is longer.I do not have untreated or symptomatic brain metastases.My lymphoma is active and causes symptoms.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (entinostat, ZEN003694)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many participants are enrolled in this experiment?
"Affirmative. Clinicaltrials.gov confirms that, as of 11/19/2022, this trial is actively recruiting participants across 4 sites and has a total enrolment goal of 30 individuals since its launch on 6/17/2022."
Answered by AI
Has the experimental drug ZEN-3694 been tested in any prior research experiments?
"The Bromodomain Inhibitor ZEN-3694 was first studied back in 2009 at Sidney Kimmel Cancer Center, part of Johns Hopkins University. Subsequently, a total of 72 clinical trials have been conducted with 18 still ongoing today; most of these are set up in New Haven, Connecticut."
Answered by AI
Are there opportunities for volunteers to join this clinical experiment?
"Affirmative. According to clinicaltrials.gov, this medical trial, which was uploaded on June 17th 2022 and last updated November 19th 2022 is actively recruiting participants. Specifically, 30 subjects are needed from 4 distinct locations."
Answered by AI
What tangible goals are researchers hoping to achieve with this research endeavor?
"This medical trial will be tracking the maximum tolerated dose as its primary outcome measure over a period of up to 28 days. Additionally, secondary objectives are focused on response rate (RR), progression free survival, and duration of response. Statistical analyses such as Kaplan-Meier method and Greenwood's variance will also be employed in order to assess possible risk factors for participants' survival using log-rank tests."
Answered by AI
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