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NCT02138929

LDE225 + Everolimus in Advanced Gastroesophageal Adenocarcinoma

Completed Phase 1 Last updated 11 June 2020
What this trial tests

Phase 1 trial testing Everolimus in Esophageal Cancer in 25 participants. Completed in 8 June 2020.

Timeline
10 November 2014
Primary endpoint
8 June 2020
8 June 2020

Quick facts

Lead sponsorM.D. Anderson Cancer Center
PhasePhase 1
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment25
Start date10 November 2014
Primary completion8 June 2020
Estimated completion8 June 2020
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

M.D. Anderson Cancer Center — full company profile →

Who can join

18 and older, any sex, with Esophageal Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The goal of this clinical research study is to find the highest tolerable dose of LDE225 that can be given in combination with everolimus to patients with esophageal or GEJ cancer. The safety of the drug combination will also be studied.

Publications & conference data

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

  1. Targeting the Sonic Hedgehog Signaling Pathway: Review of Smoothened and GLI Inhibitors.
    Rimkus TK, Carpenter RL, Qasem S, Chan M, et al · · 2016 · cited 411× · PMID 26891329 · DOI 10.3390/cancers8020022
  2. The tumor microenvironment in esophageal cancer.
    Lin EW, Karakasheva TA, Hicks PD, Bass AJ, et al · · 2016 · cited 245× · PMID 26923327 · DOI 10.1038/onc.2016.34
  3. Safety and Tolerability of Sonic Hedgehog Pathway Inhibitors in Cancer.
    Carpenter RL, Ray H. · · 2019 · cited 77× · PMID 30649745 · DOI 10.1007/s40264-018-0777-5
  4. Sonidegib: mechanism of action, pharmacology, and clinical utility for advanced basal cell carcinomas.
    Jain S, Song R, Xie J. · · 2017 · cited 72× · PMID 28352196 · DOI 10.2147/ott.s130910
  5. Recent Advances in the Clinical Targeting of Hedgehog/GLI Signaling in Cancer.
    Xie H, Paradise BD, Ma WW, Fernandez-Zapico ME. · · 2019 · cited 61× · PMID 31035664 · DOI 10.3390/cells8050394
  6. Signaling pathways in the regulation of cancer stem cells and associated targeted therapy.
    Manni W, Min W. · · 2022 · cited 52× · PMID 36226253 · DOI 10.1002/mco2.176
  7. Targeting the Hedgehog Pathway in Cancer: Current Evidence and Future Perspectives.
    Girardi D, Barrichello A, Fernandes G, Pereira A. · · 2019 · cited 52× · PMID 30759860 · DOI 10.3390/cells8020153
  8. The role of Hedgehog and Notch signaling pathway in cancer.
    Xia R, Xu M, Yang J, Ma X. · · 2022 · cited 39× · PMID 36517618 · DOI 10.1186/s43556-022-00099-8

Verify or expand the search:

Other trials of Everolimus

Trials testing the same drug.

Other recruiting trials for Esophageal Cancer

Currently open trials in the same condition.

Other M.D. Anderson Cancer Center 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/NCT02138929.

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