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NCT03339843: MiMe-A

Multiorgan Metabolic Imaging Response Assessment of Abemaciclib

Completed Phase 2 Last updated 15 March 2024
What this trial tests

Phase 2 trial testing Abemaciclib in Esophageal Adenocarcinoma in 85 participants. Completed in 20 December 2023.

Timeline
19 December 2018
Primary endpoint
12 November 2021
20 December 2023

Quick facts

Lead sponsorJules Bordet Institute
PhasePhase 2
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsequential
Maskingnone
Primary purposetreatment
Enrollment85
Start date19 December 2018
Primary completion12 November 2021
Estimated completion20 December 2023
Sites11 locations across Belgium, France

Drugs / interventions tested

Conditions studied

Sponsor

Jules Bordet Institute

Who can join

18 and older, any sex, with Esophageal Adenocarcinoma or Esophagus SCC. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Open-label, phase II, basket trial. This trial is a screening program for abemaciclib efficacy in multiple platinum-resistant tumour types by using metabolic imaging (PERCIST) and RECIST v1.1 criteria. Based on the rate of FDG-avidity and the absence of deactivation of the Rb gene function in more than 95% of cases, we propose to define 5 tumour types of interest in a preliminary stage: 1. Platinum-refractory esophageal adenocarcinoma (ADC) 2. Platinum-refractory esophageal squamous cell carcinoma (SCC) 3. Platinum-refractory cholangiocarcinoma 4. Platinum-refractory and progressive after immunotherapy urothelial cancer 5. Platinum-refractory endometrial cancer

Publications & conference data

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

  1. Systematic review of basket trials, umbrella trials, and platform trials: a landscape analysis of master protocols.
    Park JJH, Siden E, Zoratti MJ, Dron L, et al · · 2019 · cited 260× · PMID 31533793 · DOI 10.1186/s13063-019-3664-1
  2. Changing Landscape of Systemic Therapy in Biliary Tract Cancer.
    Woods E, Le D, Jakka BK, Manne A. · · 2022 · cited 31× · PMID 35565266 · DOI 10.3390/cancers14092137
  3. Immune disorder in endometrial cancer: Immunosuppressive microenvironment, mechanisms of immune evasion and immunotherapy.
    Zhan L, Liu X, Zhang J, Cao Y, et al · · 2020 · cited 19× · PMID 32782525 · DOI 10.3892/ol.2020.11774
  4. Systemic treatment options for advanced biliary tract carcinoma.
    Xie C, McGrath NA, Monge Bonilla C, Fu J. · · 2020 · cited 17× · PMID 32748173 · DOI 10.1007/s00535-020-01712-9
  5. CDK4/6 Inhibitors in Pancreatobiliary Cancers: Opportunities and Challenges.
    Arsenijevic T, Coulonval K, Raspé E, Demols A, et al · · 2023 · cited 10× · PMID 36765923 · DOI 10.3390/cancers15030968
  6. Current challenges to underpinning the genetic basis for cholangiocarcinoma.
    Cigliano A, Chen X, Calvisi DF. · · 2021 · cited 6× · PMID 33888034 · DOI 10.1080/17474124.2021.1915128
  7. Targeted therapies for extrahepatic cholangiocarcinoma: preclinical and clinical development and prospects for the clinic.
    Cadamuro M, Lasagni A, Lamarca A, Fouassier L, et al · · 2021 · cited 6× · PMID 33622120 · DOI 10.1080/13543784.2021.1880564

Verify or expand the search:

Other trials of Abemaciclib

Trials testing the same drug.

Other recruiting trials for Esophageal Adenocarcinoma

Currently open trials in the same condition.

Other Jules Bordet Institute trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03339843.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing