Your session is about to expire
← Back to Search
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
PHASE 1, PHASE 2, AND NON-THORACIC, NON-BRD4 EXPLORATORY COHORT: Platelets >= 125 x 10^9/L
Ectopic expression of NUT protein (> 50% tumor nuclei) as determined by immunohistochemistry (IHC) testing performed in a Clinical Laboratory Improvement Act (CLIA) certified laboratory
Must not have
Timeline
Screening 3 weeks
Treatment Varies
Follow Upup to 2 years
Awards & highlights
No Placebo-Only Group
Study Summary
This trial is testing a new combination of drugs to treat NUT carcinoma and to see if it works to shrink the tumor.
Eligible Conditions
- Neuroendocrine Tumors
Eligibility Criteria
Inclusion Criteria
You will be eligible if you check “Yes” for the criteria belowSelect...
You must have a platelet count of at least 125 x 10^9/L for Phase 1, Phase 2, and exploratory groups that do not focus on the lungs or BRD4.
Select...
Your tumor shows high levels of NUT protein in more than half of the cells, as confirmed by a certified lab test called immunohistochemistry.
Select...
Your medical tests showed that you have the NUT gene translocation, as determined by fluorescence in situ hybridization (FISH) performed at the Bringham and Women's Hospital (BWH) Center for Advanced Molecular Diagnostics (CAMD).
Select...
You must have cancer that can be measured using a specific set of criteria called RECIST version 1.1. If you are participating in phase 1 of the trial, you don't need to have measurable cancer but it should be evaluable in other ways.
Select...
You need to have a certain level of white blood cells called neutrophils, which is measured by a blood test.
Select...
Your hemoglobin level must be at least 9.0 g/dL to participate in the study.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
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 1)
Objective response rate (ORR) in patients following treatment with triplet combination (phase 2)
Secondary outcome measures
Duration of response (DoR) (phase 1, phase 2, and non-thoracic, non-BRD4 exploratory cohort)
Incidence of adverse events (phase 2)
ORR (phase 1 and non-thoracic, non-BRD4 exploratory cohort)
+4 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (ZEN-3694, etoposide, cisplatin)Experimental Treatment9 Interventions
Patients receive ZEN003694 PO QD on days 1-14 of each cycle or PO QD 5 days on, 2 days off over days 1-14 of each cycle depending on dosage. All patients may receive ZEN003694 PO QD on days 1-21 starting cycle 5 at the discretion of treating investigator. Patients also receive etoposide IV over 60 minutes on days 1-3 for cycles 1-4 or up to 8 cycles, and cisplatin IV over 60 minutes on day 1 of cycles 1-4 or up to 8 cycles. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients may undergo radiologic evaluation (chest x-ray, CT, PET-CT, MRI, and/or FDG-PET) at the completion of every 2 cycles or 6 weeks, and then at the end of every 3 or 4 cycles after the completion of cycle 10. Patients may also undergo biopsy between cycle 1 day 4 and cycle 1 day 14.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cisplatin
2013
Completed Phase 3
~1940
Etoposide
2010
Completed Phase 3
~2440
Magnetic Resonance Imaging
2017
Completed Phase 3
~1250
Positron Emission Tomography
2008
Completed Phase 2
~2240
Biopsy
2014
Completed Phase 4
~1180
Chest Radiography
2018
N/A
~560
Computed Tomography
2017
Completed Phase 2
~2890
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,487 Previous Clinical Trials
41,266,677 Total Patients Enrolled
76 Trials studying Neuroendocrine Tumors
10,545 Patients Enrolled for Neuroendocrine Tumors
Michael ChengPrincipal InvestigatorDana-Farber - Harvard Cancer Center LAO
1 Previous Clinical Trials
30 Total Patients Enrolled
Jia LuoPrincipal InvestigatorDana-Farber - Harvard Cancer Center LAO
1 Previous Clinical Trials
30 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are able to swallow pills and keep them down.You must have a platelet count of at least 125 x 10^9/L for Phase 1, Phase 2, and exploratory groups that do not focus on the lungs or BRD4.If you have received any bone-targeted radionuclide treatment in the past 6 weeks, you are not eligible for this study.You need to have a certain level of white blood cells called neutrophils, which is measured by a blood test.Your hemoglobin level must be at least 9.0 g/dL to participate in the study.You cannot participate in this study if you are currently taking any experimental medications.You have had an allergic reaction in the past to drugs similar to ZEN003694 or other drugs used in this study.Your tumor shows high levels of NUT protein in more than half of the cells, as confirmed by a certified lab test called immunohistochemistry.Your medical tests showed that you have the NUT gene translocation, as determined by fluorescence in situ hybridization (FISH) performed at the Bringham and Women's Hospital (BWH) Center for Advanced Molecular Diagnostics (CAMD).You have a type of disease that has spread to other parts of your body, or it cannot be removed with surgery, or surgery is not a good option for you. If you already had surgery, you can still participate in the study.You are at least 12 years old and weigh at least 40 kilograms. Children younger than 12 years old cannot participate because the medication has not been tested enough in younger children.If you are 16 years or older, your performance status should be equal to or less than 2 (measured through the Eastern Cooperative Oncology Group score), which means you should have a Karnofsky score of 60% or higher. If you are under 16 years old, your performance status should be measured through the Lansky score, and it should be 50% or higher. This criterion applies to Phase 1, Phase 2, and non-thoracic/non-BRD4 exploratory cohort.You must have cancer that can be measured using a specific set of criteria called RECIST version 1.1. If you are participating in phase 1 of the trial, you don't need to have measurable cancer but it should be evaluable in other ways.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (ZEN-3694, etoposide, cisplatin)
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.
Is enrollment still taking place for this research endeavor?
"Indeed, the information posted on clinicaltrials.gov indicates that enrollment for this medical trial is currently ongoing. The study became available to participants in late April 2022 and has been recently updated in November of the same year; it requires 55 volunteers from 2 different locations."
Answered by AI
What maladies has BET Bromodomain Inhibitor ZEN-3694 been utilized to combat?
"ZEN-3694, a BET Bromodomain Inhibitor, is usually used to manage advanced cases. Additionally, it has been administered with success in the treatment of merkel cell cancer, neoplasm metastasis and prostate cancerl cancer, neoplasm metastasis and prostate cancer."
Answered by AI
Can you inform me of any other experiments involving the BET Bromodomain Inhibitor ZEN-3694?
"At present, 950 trials are being conducted to research the efficacy of BET Bromodomain Inhibitor ZEN-3694. Of those clinical studies, 338 are in their third phase. Beijing remains the epicenter for these experiments; however, 51625 sites have opened up across the world looking into its potential applications."
Answered by AI
How many volunteers have taken part in this research study?
"Affirmative. According to information found on clinicaltrials.gov, this trial is actively recruiting and has been since April 29th 2022. The study seeks 55 patients from two different medical centres for enrollment as of November 29th 2022."
Answered by AI
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger