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Alkylating agents
ZEN003694 + Chemotherapy for Cancer
Boston, MA
Phase 1 & 2
Recruiting
Led By Michael Cheng
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
Calculated creatinine clearance >= 60 mL/min (based on the calculated Chronic Kidney Disease Epidemiology Collaboration [CKD-EPI] glomerular filtration rate estimation for adults or 60 mL/min/1.73m^2 for patients 12-17 years as calculated based on bedside Schwartz formula
Participants must have a diagnosis of NC based on standard criteria for the disease, with diagnostic testing performed in a Clinical Laboratory Improvement Act (CLIA) certified laboratory: Ectopic expression of NUT protein per World Health Organization (WHO) criteria as determined by immunohistochemistry (IHC) testing, Detection of the NUT gene translocation as determined by fluorescence in situ hybridization (FISH) testing, Detection of the NUT gene translocation as determined by sequencing, eg. DNA next generation sequencing (NGS) or RNA sequencing.
Must not have
Pregnant women are excluded from this study because ZEN003694 is a bromodomain and extraterminal domain (BET) inhibitor with the potential for teratogenic or abortifacient effects.
Participants with known untreated central nervous system (CNS) metastases.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing a new combination of drugs to treat NUT carcinoma and to see if it works to shrink the tumor.
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Who is the study for?
Adults and children (12-17 years) with NUT carcinoma, a rare cancer type. Participants must be able to swallow pills, have certain blood counts within normal ranges, no severe liver or kidney issues, not on specific anticoagulants or other investigational drugs, and without untreated brain metastases. They should also not have gastrointestinal disorders affecting drug absorption.Check my eligibility
What is being tested?
The trial is testing the safety and effectiveness of adding ZEN003694 to standard chemotherapy (etoposide and cisplatin). It aims to find the best dose that's safe in phase I and then see if this combination can shrink tumors in phase II. The study will also look at changes in tumor/blood characteristics due to treatment.See study design
What are the potential side effects?
Potential side effects include reactions related to the new drug ZEN003694 which may affect organ function similar to other anti-cancer medications. Chemotherapy with etoposide and cisplatin can cause nausea, hair loss, fatigue, increased risk of infection due to low blood cell counts.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My kidney function, measured by creatinine clearance, is good.
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My diagnosis of NUT carcinoma was confirmed by a certified lab using specific tests.
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I haven't had certain cancer treatments in the last 2 weeks or 5 half-lives, whichever is shorter.
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I am mostly active and can care for myself, regardless of my age.
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My bilirubin levels are within the normal range for my age.
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I can swallow and keep down pills.
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I had hepatitis C but am cured, or I'm being treated with an undetectable viral load.
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My hepatitis B virus is undetectable with treatment.
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My heart's electrical cycle is within a normal range.
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Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am not pregnant, as the study drug may harm my unborn baby.
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I have brain metastases that have not been treated.
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I am not taking strong medication that affects liver enzymes.
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I cannot receive EP treatment.
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I have a history of serious heart problems.
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I have never been treated with BET inhibitors, including ZEN003694.
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I am not on blood thinners like warfarin or LMWH.
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I do not have any severe illnesses that are not under control.
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My cancer started in the chest area.
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More than a quarter of my bone marrow has been exposed to radiation.
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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
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Maximum tolerated dose (MTD) (phase 1)
Objective response rate (ORR) in patients following treatment with triplet combination (phase 2)
Secondary study objectives
Duration of response (DoR) (phase 1, phase 2, and non-thoracic, non-BRD4 exploratory cohort)
ORR (phase 1 and non-thoracic, non-BRD4 exploratory cohort)
Overall survival (phase 1, phase 2, and non-thoracic, non-BRD4 exploratory cohort)
+3 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 Treatment10 Interventions
Patients receive ZEN003694 PO once or twice daily on days 1-14 or days 1-21 of each cycle depending upon dosage assignment. 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), blood and urine sample collection and biopsy throughout the study.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cisplatin
2013
Completed Phase 3
~3120
Computed Tomography
2017
Completed Phase 2
~2440
FDG-Positron Emission Tomography
2017
Completed Phase 2
~20
Biospecimen Collection
2004
Completed Phase 3
~1810
Etoposide
2010
Completed Phase 3
~2960
Magnetic Resonance Imaging
2020
Completed Phase 3
~1220
Biopsy
2014
Completed Phase 4
~1210
Chest Radiography
2018
N/A
~560
Positron Emission Tomography
2011
Completed Phase 2
~2230
Find a Location
Closest Location:M D Anderson Cancer Center· Houston, TX· 574 miles
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
14,028 Previous Clinical Trials
41,153,268 Total Patients Enrolled
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:- I am HIV positive, on effective treatment, and my viral load is undetectable.My kidney function, measured by creatinine clearance, is good.Any side effects from previous treatments have mostly gone away, except for hair loss, nerve issues, or skin rash.I have another cancer that won't affect this treatment's safety or results.My diagnosis of NUT carcinoma was confirmed by a certified lab using specific tests.My cancer has spread, cannot be removed by surgery, or surgery won't help me live longer.I am not pregnant, as the study drug may harm my unborn baby.I have brain metastases that have not been treated.I am not taking strong medication that affects liver enzymes.I cannot receive EP treatment.I am eligible to receive the study drugs at the set dose and schedule.I am at least 12 years old and weigh at least 40 kg if under 18.I haven't had certain cancer treatments in the last 2 weeks or 5 half-lives, whichever is shorter.I do not have any unmanaged ongoing illnesses.I agree to use effective birth control during and for 4 months after the study.I am mostly active and can care for myself, regardless of my age.I completed my radiation therapy at least a week ago.My bilirubin levels are within the normal range for my age.I can understand and am willing to sign the consent form, or I have someone who can do it for me.I can swallow and keep down pills.I have a history of serious heart problems.My cancer can be measured by standard criteria, or it's evaluable if I'm in phase 1 of the study.I have never been treated with BET inhibitors, including ZEN003694.I am not on blood thinners like warfarin or LMWH.I am a woman who can have children and have a recent negative pregnancy test.I had hepatitis C but am cured, or I'm being treated with an undetectable viral load.I do not have any severe illnesses that are not under control.My cancer started in the chest area.I do not have a stomach or bowel condition that affects how I absorb pills.More than a quarter of my bone marrow has been exposed to radiation.My hepatitis B virus is undetectable with treatment.I have had up to 2 cycles of EP (cisplatin + etoposide) treatment.I had major surgery and it's been over 3 weeks since.My heart's electrical cycle is within a normal range.
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.