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Table 1 NUT midline carcinoma clinical trials available at Clinicaltrials.gov

From: The first report of molecular characterized BRD4-NUT carcinoma in Brazil: a case report

Trial Type of study/ population Regimen Mechanism of action Status
NCT01587703 Phase I/II – Diagnosis of NMC determined by IHC and/or detection of NUT gene translocation by FISH, treatment naïve or with prior therapy GSK525762 BET protein inhibitor Active, not recruiting
NCT03702036 Compassionate use – Diagnosis of NMC determined by IHC and/or detection of NUT gene translocation by FISH, with no other satisfactory alternative treatment GSK525762 (molibresib) Inhibitor of the binding of BET proteins to acetylated histones Available
NCT02307240 Phase I – Diagnosis of an advanced solid tumor such as breast cancer or NMC, that has progressed despite standard therapy, or for which no standard therapy exists CUDC-907 HDAC and PI3K Inhibitor Active, not recruiting
NCT02698176 Phase IB – Diagnosis of one of the following advanced solid tumors for which standard therapy either does not exist or has proven ineffective, intolerable, or inacceptable for the participant: NMC;TNBC; NSCLC; or CRPC MK-8628 BET protein inhibitor Terminated due to limited efficacy
NCT02516553 Phase I – Diagnosis of advanced unresectable and/or metastatic solid tumor, refractory to conventional treatment or for whom no therapy of proven efficacy exists, or who are not amenable to standard therapies.
Part Ib includes patients with SCLC, CRPC, CRC or NMC
BI 894999 BET protein inhibitor Recruiting
NCT02259114 Phase I – Advanced or metastatic: TNBC, NSCLC, CRPC, pancreatic ductal adenocarcinoma, NMC, for which standard therapy either does not exist or has proven ineffective, intolerable or inacceptable for the patient OTX015/MK-8628 (birabresib) BET protein inhibitor 3/10 patients with NMC with PR with duration of 1.4 to 8.4 months
NCT02711137 Phase 1/2 – Histologically or cytologically confirmed diagnosis of relapsed or refractory advanced or metastatic malignancies (solid or hematologic) INCB057643 BET protein inhibitor Terminated due to safety issues
NCT02431260 Phase 1/2 – Any advanced solid tumor or lymphoma; acute leukemia, myelodysplastic syndrome, myelodysplastic /myeloproliferative neoplasms, myelofibrosis, and multiple myeloma INCB054329 BET protein inhibitor Terminated by the sponsor due to pharmacokinetics variability [20]
NCT02369029 Phase 1 – Patients with advanced tumors refractory to any standard treatment, with no standard therapy available or in whom standard therapy is not a therapeutic option BAY1238097 BET protein inhibitor Terminated because of dose-limiting toxicities at a dose below targeted drug exposure [21]
  1. BET bromodomain and extraterminal, CRPC castration-resistant prostate cancer, CRC colorectal cancer, FISH fluorescence in situ hybridization, HDAC histone deacetylase, IHC immunohistochemistry, NMC NUT midline carcinoma, NSCLC non-small cell lung cancer, PI3K phosphoinositide 3-kinase, PR partial response, SCLC small cell lung cancer, TNBC triple negative breast cancer