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NCT03193437: SELECT

Selinexor in Patients With Advanced Thymic Epithelial Tumor Progressing After Primary Chemotherapy

Terminated Phase 2 Results posted Last updated 16 February 2023
What this trial tests

Phase 2 trial testing Open Label Selinexor in Thymoma in 8 participants. Terminated before completion.

Timeline
3 April 2018
Primary endpoint
27 July 2020
31 January 2022

Quick facts

Lead sponsorGeorgetown University
PhasePhase 2
StatusTerminated
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment8
Start date3 April 2018
Primary completion27 July 2020
Estimated completion31 January 2022
Sites2 locations across United States

Drugs / interventions tested

Conditions studied

Sponsor

Georgetown University

Who can join

18 and older, any sex, with Thymoma or Advanced Thymic Epithelial Tumor. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Overall Response Rate Primary · 24 months

To determine the overall response rate per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by CT: Complete Response (CR), Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm.; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR+ PR.

GroupValue95% CI
Selinexor0
Overall Response Rate Secondary · 24 months

To determine the overall response rate to according to modified ITMIG response criteria. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT and MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.

GroupValue95% CI
Selinexor0
6 Month Progression Free Survival Rate Secondary · 6 months

To determine six months progression free survival of patients with TET treated with selinexor

GroupValue95% CI
Selinexor55.6
24 Month Overall Survival Rate Secondary · 24 months

To determine overall survival of patients with TET treated with selinexor

GroupValue95% CI
Selinexor57.1
Adverse Events Secondary · 24 months

The number of adverse events as determined by Common Terminology Criteria for Adverse Events (CTCAEs) version 4.03

GroupValue95% CI
Selinexor93

Adverse events — posted to ClinicalTrials.gov

Time frame: From the time of consent to 30 days following the last dose of study treatment (max 24 months).. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Selinexor
Serious: 5/8 (63%)
Deaths: 1/8

Serious adverse events (3 terms)

ReactionSystemSelinexor
PneumonitisRespiratory, thoracic and mediastinal disorders
PneumoniaInfections and infestations
Febrile NeutropeniaBlood and lymphatic system disorders
Other adverse events (39 terms — click to expand)

ReactionSystemSelinexor
NauseaGastrointestinal disorders
AnorexiaMetabolism and nutrition disorders
AnemiaBlood and lymphatic system disorders
VomitingGastrointestinal disorders
Platelet count decreasedInvestigations
DysgeusiaNervous system disorders
DyspneaRespiratory, thoracic and mediastinal disorders
ConstipationGastrointestinal disorders
DiarrheaGastrointestinal disorders
Mucositis oralGastrointestinal disorders
FatigueGeneral disorders
Alanine aminotransferase increasedInvestigations
Aspartate aminotransferase increasedInvestigations
Electrocardiogram QT corrected interval prolongedInvestigations
Cardiac Disorders other, specifyCardiac disorders
CataractEye disorders
Dry eyeEye disorders
Eye disorders - Other, specifyEye disorders
Abdominal painGastrointestinal disorders
astheniaGeneral disorders
lightheadednessGeneral disorders
Edema limbsGeneral disorders
FeverGeneral disorders
Infections and infestations - Other, specifyInfections and infestations
Mucosal infectionInfections and infestations
Skin infectionInfections and infestations
Upper respiratory infectionInfections and infestations
Weight lossInvestigations
DehydrationMetabolism and nutrition disorders
HypomagnesemiaMetabolism and nutrition disorders
Nervous system disorders - Other, specifyNervous system disorders
Peripheral sensory neuropathyNervous system disorders
AgitationPsychiatric disorders
CoughRespiratory, thoracic and mediastinal disorders
PneumonitisRespiratory, thoracic and mediastinal disorders
Postnasal dripRespiratory, thoracic and mediastinal disorders
AlopeciaSkin and subcutaneous tissue disorders
RashSkin and subcutaneous tissue disorders
Rash maculo-papularSkin and subcutaneous tissue disorders

Most-reported serious reactions: Pneumonitis, Pneumonia, Febrile Neutropenia.

Data from ClinicalTrials.gov NCT03193437 adverse events section.

Sponsor's own description

The purpose of this study is to evaluate the safety, tolerability and effectiveness of selinexor in patients with advanced thymic epithelial tumor progressing after primary chemotherapy. This is a multicenter, open label phase II trial that uses a Simons two stage design. The study population is adults with histologically confirmed, advanced, inoperable TETs who are progressing after treatment with at least one platinum containing chemotherapy regimen. This study is comprised of 2 similar phase II trials, one running in US (25 patients) and one running in EU (25 patients): There are two study arms: Arm A: Thymoma * Stage 1: 15 patients * Stage 2: 10 patients Arm B: Thymic carcinoma * Stage 1: 15 patients * Stage 2: 10 patients

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Small Molecule NF-κB Pathway Inhibitors in Clinic.
    Ramadass V, Vaiyapuri T, Tergaonkar V. · · 2020 · cited 154× · PMID 32708302 · DOI 10.3390/ijms21145164
  2. The past, present, and future of CRM1/XPO1 inhibitors.
    Wang AY, Liu H. · · 2019 · cited 85× · PMID 30976603 · DOI 10.21037/sci.2019.02.03
  3. Clinical management of patients with thymic epithelial tumors: the recommendations endorsed by the Italian Association of Medical Oncology (AIOM).
    Conforti F, Marino M, Vitolo V, Spaggiari L, et al · · 2021 · cited 16× · PMID 34116501 · DOI 10.1016/j.esmoop.2021.100188
  4. An Overview on Molecular Characterization of Thymic Tumors: Old and New Targets for Clinical Advances.
    Tateo V, Manuzzi L, Parisi C, De Giglio A, et al · · 2021 · cited 16× · PMID 33915954 · DOI 10.3390/ph14040316
  5. Deciphering the biology of thymic epithelial tumors.
    Rajan A, Zhao C. · · 2019 · cited 15× · PMID 31608319 · DOI 10.21037/med.2019.08.03
  6. Emerging therapies in thymic epithelial tumors (Review).
    Dapergola A, Gomatou G, Trontzas I, Panagiotou E, et al · · 2023 · cited 5× · PMID 36760515 · DOI 10.3892/ol.2023.13670
  7. Selinexor and the Selective Inhibition of Nuclear Export: A New Perspective on the Treatment of Sarcomas and Other Solid and Non-Solid Tumors.
    Marretta AL, Di Lorenzo G, Ribera D, Cannella L, et al · · 2021 · cited 5× · PMID 34575598 · DOI 10.3390/pharmaceutics13091522
  8. Prognostic and functional role of the nuclear export receptor 1 (XPO1) in gastrointestinal cancers: a potential novel target?
    Sokolova V, Gruber R, Pammer LM, Kocher F, et al · · 2024 · cited 1× · PMID 39729162 · DOI 10.1007/s11033-024-10169-5

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