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Alkylating agents

ZEN003694 + Chemotherapy for Cancer

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.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years

Awards & highlights

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.

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 below

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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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

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 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (ZEN-3694, etoposide, cisplatin)Experimental Treatment9 Interventions

Patients receive ZEN003694 orally (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) 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

Biopsy

2014

Completed Phase 4

~1090

Chest Radiography

2018

N/A

~560

Computed Tomography

2017

Completed Phase 2

~2720

Etoposide

2010

Completed Phase 3

~2440

Magnetic Resonance Imaging

2017

Completed Phase 3

~1190

Positron Emission Tomography

2008

Completed Phase 2

~2240

0 / 9Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor

13,692 Previous Clinical Trials

40,929,821 Total Patients Enrolled

79 Trials studying Neuroendocrine Tumors

43,474 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

Cisplatin (Alkylating agents) Clinical Trial Eligibility Overview. Trial Name: NCT05019716 — Phase 1 & 2

Neuroendocrine Tumors Research Study Groups: Treatment (ZEN-3694, etoposide, cisplatin)

Neuroendocrine Tumors Clinical Trial 2023: Cisplatin Highlights & Side Effects. Trial Name: NCT05019716 — Phase 1 & 2

Cisplatin (Alkylating agents) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05019716 — Phase 1 & 2

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 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

Recent research and studies

clinicaltrials.govStudy

Testing the Safety and Efficacy of the Addition of A New Anti-cancer Drug, ZEN003694, to Chemotherapy Treatment (Etoposide and Cisplatin) for Adult and Pediatric Patients (12-17 Years) With NUT Carcinoma

2022. "Testing the Safety and Efficacy of the Addition of A New Anti-cancer Drug, ZEN003694, to Chemotherapy Treatment (Etoposide and Cisplatin) for Adult and Pediatric Patients (12-17 Years) With NUT Carcinoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05019716.