← Back to Search

Alkylating agents

ZEN003694 + Chemotherapy for NUT Carcinoma

Dana-Farber - Harvard Cancer Center LAO, Boston, MA
Targeting 3 different conditionsBET Bromodomain Inhibitor ZEN-3694 +8 morePhase 1 & 2RecruitingLed by Michael ChengResearch Sponsored by National Cancer Institute (NCI)

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 below
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.
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 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.
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.


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

Awards & 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.
First Studied
Drug Approval Stage
How many patients have taken this drug
Completed Phase 3
Completed Phase 3
Magnetic Resonance Imaging
Completed Phase 3
Positron Emission Tomography
Completed Phase 2
Completed Phase 4
Chest Radiography
Computed Tomography
Completed Phase 2

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

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 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
~0 spots leftby Dec 2023