Recruiting PHASE1, PHASE2 Advanced NUT Carcinoma

Tests treatment safety and results for Advanced NUT Carcinoma

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

ClinicalTrials.gov ID: NCT05019716

What this study is testing

What is BET Bromodomain Inhibitor ZEN-3694?

BET Bromodomain Inhibitor ZEN-3694 is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for advanced nut carcinoma.

Also referred to as BETi ZEN-3694, ZEN 3694.

Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.

What it's testing
This phase I trial tests the safety, side effects, and best dose of ZEN003694 in combination with cisplatin and etoposide or carboplatin and paclitaxel in treating patients with NUT carcinoma. Another purpose of this study is to see whether there are any changes in patient's tumor or blood characteristics (e.g.
  • Phase 2: a mid-size study of how well it works

A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.

Who can take part

Ages 12 and older

You may be able to join if

  • PHASE 1, CARBOPLATIN/PACLITAXEL SAFETY COHORT, \& NON-THORACIC, NON-BRD4 EXPLORATORY COHORT: Participants must have a diagnosis of NC based on...
  • Ectopic expression of NUT protein per World Health Organization (WHO) criteria (World Health Organization [WHO], 2021) as determined by...
  • Detection of the NUT gene translocation as determined by fluorescence in situ hybridization (FISH) testing, OR
  • Detection of the NUT gene translocation as determined by sequencing, eg. DNA next generation sequencing (NGS) or RNA sequencing.
  • PHASE 1, CARBOPLATIN/PACLITAXEL SAFETY COHORT, \& NON-THORACIC, NON-BRD4 EXPLORATORY COHORT: Participants must have disease that is metastatic...

You likely can't join if

  • PHASE 1, NON-THORACIC, NON-BRD4 EXPLORATORY COHORT, \& CARBOPLATIN/PACLITAXEL SAFETY COHORT: Participants with known untreated central nervous system...
  • Radiologically stable for 4 weeks.
  • Disease outside the CNS is present.
  • Recovery from acute toxicity associated with the treatment to =\< Common Terminology Criteria for Adverse Events (CTCAE) grade 1 or baseline (with...
  • people currently taking enzyme-inducing anticonvulsants (EIAC) must be transitioned to non-enzyme inducing anticonvulsants at least 14 days or 5...
  • No presence of symptomatic or untreated leptomeningeal metastases or spinal cord compression.
See the full eligibility criteria
Who can join
  • PHASE 1, CARBOPLATIN/PACLITAXEL SAFETY COHORT, \& NON-THORACIC, NON-BRD4 EXPLORATORY COHORT: Participants must have a diagnosis of NC based on standard criteria for the disease, with diagnostic testing performed in a...
  • Ectopic expression of NUT protein per World Health Organization (WHO) criteria (World Health Organization [WHO], 2021) as determined by immunohistochemistry (IHC) testing, OR
  • Detection of the NUT gene translocation as determined by fluorescence in situ hybridization (FISH) testing, OR
  • Detection of the NUT gene translocation as determined by sequencing, eg. DNA next generation sequencing (NGS) or RNA sequencing.
  • PHASE 1, CARBOPLATIN/PACLITAXEL SAFETY COHORT, \& NON-THORACIC, NON-BRD4 EXPLORATORY COHORT: Participants must have disease that is metastatic, unresectable, or for which a surgical approach would not likely confer a...
  • PHASE 1, CARBOPLATIN/PACLITAXEL SAFETY COHORT, \& NON-THORACIC, NON-BRD4 EXPLORATORY COHORT: Age \>= 12 years. Patients 12-17 years of age must be \>= 40 kg at enrollment. Because no dosing or adverse event data are...
  • PHASE 1, CARBOPLATIN/PACLITAXEL SAFETY COHORT, \& NON-THORACIC, NON-BRD4 EXPLORATORY COHORT: Eastern Cooperative Oncology Group (ECOG) performance status of =\ = 60%) for patients \>= 16 years of age, Lansky \>= 50% if...
  • PHASE 1, CARBOPLATIN/PACLITAXEL SAFETY COHORT, \& NON-THORACIC, NON-BRD4 EXPLORATORY COHORT: Participants must have measurable disease per RECIST version 1.1 criteria. Patients in the phase 1 portion do not need...
  • PHASE 1, CARBOPLATIN/PACLITAXEL SAFETY COHORT, \& NON-THORACIC, NON-BRD4 EXPLORATORY COHORT: Ability to swallow and retain oral medications.
  • PHASE 1, CARBOPLATIN/PACLITAXEL SAFETY COHORT, \& NON-THORACIC, NON-BRD4 EXPLORATORY COHORT: Absolute neutrophil count \>= 1.5 x 10\^9/L.
  • PHASE 1, CARBOPLATIN/PACLITAXEL SAFETY COHORT, \& NON-THORACIC, NON-BRD4 EXPLORATORY COHORT: Platelets \>= 125 x 10\^9/L.
  • PHASE 1, CARBOPLATIN/PACLITAXEL SAFETY COHORT, \& NON-THORACIC, NON-BRD4 EXPLORATORY COHORT: Hemoglobin \>= 9.0 g/dL.
  • PHASE 1, CARBOPLATIN/PACLITAXEL SAFETY COHORT, \& NON-THORACIC, NON-BRD4 EXPLORATORY COHORT: Albumin \>= 2.5 g/dL.
  • PHASE 1, CARBOPLATIN/PACLITAXEL SAFETY COHORT, \& NON-THORACIC, NON-BRD4 EXPLORATORY COHORT: Total bilirubin =\< 1.5 x institutional upper limit of normal (ULN) for age.
  • PHASE 1, CARBOPLATIN/PACLITAXEL SAFETY COHORT, \& NON-THORACIC, NON-BRD4 EXPLORATORY COHORT: Aspartate aminotransferase (AST)(serum glutamic-oxaloacetic transaminase [SGOT])/alanine aminotransferase(ALT)(serum glutamate...
  • PHASE 1, CARBOPLATIN/PACLITAXEL SAFETY COHORT, \& NON-THORACIC, NON-BRD4 EXPLORATORY COHORT: Calculated creatinine clearance \>= 60 mL/min (based on the calculated Chronic Kidney Disease Epidemiology Collaboration...
  • PHASE 1, CARBOPLATIN/PACLITAXEL SAFETY COHORT, \& NON-THORACIC, NON-BRD4 EXPLORATORY COHORT: Prothrombin time (PT)/international normalized ratio (INR) =\< 1.5 x ULN.
  • PHASE 1, CARBOPLATIN/PACLITAXEL SAFETY COHORT, \& NON-THORACIC, NON-BRD4 EXPLORATORY COHORT: Partial thromboplastin time (PTT) =\< 1.5 x ULN.
  • PHASE 1, CARBOPLATIN/PACLITAXEL SAFETY COHORT, \& NON-THORACIC, NON-BRD4 EXPLORATORY COHORT: QT interval by Fridericia (QTcF) \< 450 ms (machine or manual read allowed). Patients should avoid medications which prolong...
  • PHASE 1, CARBOPLATIN/PACLITAXEL SAFETY COHORT, \& NON-THORACIC, NON-BRD4 EXPLORATORY COHORT: Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within...
  • PHASE 1, CARBOPLATIN/PACLITAXEL SAFETY COHORT, \& NON-THORACIC, NON-BRD4 EXPLORATORY COHORT: For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on...
  • PHASE 1, CARBOPLATIN/PACLITAXEL SAFETY COHORT, \& NON-THORACIC, NON-BRD4 EXPLORATORY COHORT: Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection...
  • PHASE 1, CARBOPLATIN/PACLITAXEL SAFETY COHORT, \& NON-THORACIC, NON-BRD4 EXPLORATORY COHORT: Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere...
  • PHASE 1, CARBOPLATIN/PACLITAXEL SAFETY COHORT, \& NON-THORACIC, NON-BRD4 EXPLORATORY COHORT: The effects of ZEN003694 on the developing human fetus are unknown. For this reason and because the chemotherapeutic agents...
  • Vasectomy with documentation of azoospermia OR
  • Condom use PLUS partner use of a highly effective contraceptive (=\< 1% rate of failure per year) such as intrauterine device or system, or hormonal birth control such as contraceptive subdermal implant, combined...
  • PHASE 1, CARBOPLATIN/PACLITAXEL SAFETY COHORT, \& NON-THORACIC, NON-BRD4 EXPLORATORY COHORT: Male people should not donate sperm while on study and for 16 weeks after the last dose of study medication. Male people whose...
  • PHASE 1, CARBOPLATIN/PACLITAXEL SAFETY COHORT, \& NON-THORACIC, NON-BRD4 EXPLORATORY COHORT: Ability to understand and the willingness to sign a written informed consent document (or parent or legally authorized...
  • PHASE 1, CARBOPLATIN/PACLITAXEL SAFETY COHORT, \& NON-THORACIC, NON-BRD4 EXPLORATORY COHORT: Women of childbearing potential must have a negative pregnancy test within 7 days of starting treatment.
  • PHASE 1, CARBOPLATIN/PACLITAXEL SAFETY COHORT, \& NON-THORACIC, NON-BRD4 EXPLORATORY COHORT: Participants who have not had cytotoxic chemotherapy, oral tyrosine kinase inhibitor (TKI) or small molecule therapy, or...
  • PHASE 1, CARBOPLATIN/PACLITAXEL SAFETY COHORT, \& NON-THORACIC, NON-BRD4 EXPLORATORY COHORT: Participants may have had a maximum of 1 prior cycle of EP (cisplatin + etoposide) or carboplatin/paclitaxel. However, for...
  • PHASE 1, CARBOPLATIN/PACLITAXEL SAFETY COHORT, \& NON-THORACIC, NON-BRD4 EXPLORATORY COHORT: Participants who have received prior radiation therapy can be enrolled at least 1 week after completing radiation.
  • PHASE 1, CARBOPLATIN/PACLITAXEL SAFETY COHORT, \& NON-THORACIC, NON-BRD4 EXPLORATORY COHORT: Participants who have had major surgery can be enrolled at least 3 weeks after the surgery.
  • PHASE 1, CARBOPLATIN/PACLITAXEL SAFETY COHORT, \& NON-THORACIC, NON-BRD4 EXPLORATORY COHORT: Any therapy-related toxicities must have resolved to ≤ grade 1 or baseline (with the exception of alopecia, peripheral...
  • NON-THORACIC, NON-BRD4 EXPLORATORY COHORT: Participants must have a diagnosis of NC but lack BRD4-NUT rearrangement. If the fusion status is unknown after NC diagnosis, the BRD4-NUT fusion status will be determined by...
What rules you out
  • PHASE 1, NON-THORACIC, NON-BRD4 EXPLORATORY COHORT, \& CARBOPLATIN/PACLITAXEL SAFETY COHORT: Participants with known untreated central nervous system (CNS) metastases. Patients with a history of treated CNS metastases...
  • Radiologically stable for 4 weeks.
  • Disease outside the CNS is present.
  • Recovery from acute toxicity associated with the treatment to =\< Common Terminology Criteria for Adverse Events (CTCAE) grade 1 or baseline (with the exception of alopecia), with no requirement for escalating doses of...
  • people currently taking enzyme-inducing anticonvulsants (EIAC) must be transitioned to non-enzyme inducing anticonvulsants at least 14 days or 5 half-lives prior to the first dose of study medication
  • No presence of symptomatic or untreated leptomeningeal metastases or spinal cord compression.
  • PHASE 1, NON-THORACIC, NON-BRD4 EXPLORATORY COHORT, \& CARBOPLATIN/PACLITAXEL SAFETY COHORT: History of allergic reactions attributed to compounds of similar chemical or biologic composition to ZEN003694 or other agents...
  • PHASE 1, NON-THORACIC, NON-BRD4 EXPLORATORY COHORT, \& CARBOPLATIN/PACLITAXEL SAFETY COHORT: Uncontrolled intercurrent illness including, but not limited to: ongoing or active infection requiring systemic treatment...
  • PHASE 1, NON-THORACIC, NON-BRD4 EXPLORATORY COHORT, \& CARBOPLATIN/PACLITAXEL SAFETY COHORT: Any gastrointestinal (GI) disorder that may affect absorption of ZEN003694 and other oral medications in the opinion of the...
  • PHASE 1, NON-THORACIC, NON-BRD4 EXPLORATORY COHORT, \& CARBOPLATIN/PACLITAXEL SAFETY COHORT: Patients who are receiving any other investigational agents.
  • PHASE 1, NON-THORACIC, NON-BRD4 EXPLORATORY COHORT, \& CARBOPLATIN/PACLITAXEL SAFETY COHORT: Patients receiving any medications or substances that are strong inhibitors or inducers of CYP3A4 or substrates of CYP1A2 with...
  • PHASE 1, NON-THORACIC, NON-BRD4 EXPLORATORY COHORT, \& CARBOPLATIN/PACLITAXEL SAFETY COHORT: Pregnant women are excluded from this study because ZEN003694 is a bromodomain and extraterminal domain (BET) inhibitor with...
  • PHASE 1, NON-THORACIC, NON-BRD4 EXPLORATORY COHORT, \& CARBOPLATIN/PACLITAXEL SAFETY COHORT: Patients receiving therapeutic-dose anticoagulation (e.g., warfarin, low-molecular weight heparin [LMWH], or novel oral...
  • PHASE 1, NON-THORACIC, NON-BRD4 EXPLORATORY COHORT, \& CARBOPLATIN/PACLITAXEL SAFETY COHORT: Patients with radiation to \> 25% of the bone marrow.
  • PHASE 1, NON-THORACIC, NON-BRD4 EXPLORATORY COHORT, \& CARBOPLATIN/PACLITAXEL SAFETY COHORT: Cardiac abnormalities as evidenced by any of the following:
  • Clinically significant conduction abnormalities or arrhythmias.
  • History or evidence of current \>= class II congestive heart failure as defined by New York Heart Association (NYHA).
  • History of acute coronary syndromes (including unstable angina and myocardial infarction), coronary angioplasty, or stenting within the past 3 months. people with a history of stent placement requiring ongoing...
  • Clinically significant cardiomegaly, ventricular hypertrophy, or cardiomyopathy.
  • PHASE 1, NON-THORACIC, NON-BRD4 EXPLORATORY COHORT, \& CARBOPLATIN/PACLITAXEL SAFETY COHORT: Patients with uncontrolled intercurrent illness.
  • PHASE 1, NON-THORACIC, NON-BRD4 EXPLORATORY COHORT, \& CARBOPLATIN/PACLITAXEL SAFETY COHORT: Patients with psychiatric illness/social situations that would limit compliance with study requirements.
  • PHASE 1: Patients who are currently receiving EP or ZEN003694, or received EP or ZEN003694 in the past, must be candidates to receive the study agents at the protocol-defined dose level and schedule as judged by the...
  • ZEN003694/CARBOPLATIN/PACLITAXEL SAFETY COHORT: Patients who are currently receiving carboplatin/paclitaxel or ZEN003694, or received carboplatin/paclitaxel or ZEN003694 in the past, must be candidates to receive the...
  • PHASE 1 OR ZEN003694/CARBOPLATIN/PACLITAXEL SAFETY COHORT: Patients ineligible for receiving EP or carboplatin/paclitaxel for either the phase 1 dose escalation or the carboplatin/paclitaxel safety cohort, respectively.
  • NON-THORACIC, NON-BRD4 EXPLORATORY COHORT: Patients with disease that definitively originated in the thoracic cavity. In the case of patients with metastatic disease at diagnosis where disease origin is uncertain, the...
  • NON-THORACIC, NON-BRD4 EXPLORATORY COHORT: Patients who previously received treatment with a BET inhibitor (BETi), including but not limited to previous ZEN003694 therapy.

The study team makes the final eligibility decision.

Where it's taking place

  • Los Angeles, California, United States
  • Boston, Massachusetts, United States
  • Pittsburgh, Pennsylvania, United States
  • Houston, Texas, United States

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 12 years and older. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include Los Angeles, California, United States; Boston, Massachusetts, United States; Pittsburgh, Pennsylvania, United States; Houston, Texas, United States. Enter your location above to see the nearest site and check your eligibility.

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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.