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NCT02138929
LDE225 + Everolimus in Advanced Gastroesophageal Adenocarcinoma
Phase 1 trial testing Everolimus in Esophageal Cancer in 25 participants. Completed in 8 June 2020.
8 June 2020
Quick facts
| Lead sponsor | M.D. Anderson Cancer Center |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 25 |
| Start date | 10 November 2014 |
| Primary completion | 8 June 2020 |
| Estimated completion | 8 June 2020 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Everolimus (everolimus) — full drug profile →
- LDE 225 — full drug profile →
Conditions studied
- Esophageal Cancer — all drugs for Esophageal Cancer →
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):
-
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 -
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 -
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 -
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 -
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 -
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 -
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 -
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:
- PubMed search for NCT02138929
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT02138929 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by M.D. Anderson Cancer Center
- Last refreshed: 11 June 2020
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.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing