NCT01806649 is a Phase 2 clinical trial of BKM120 in Esophageal Cancer, sponsored by Prince of Songkla University.

Who is sponsoring NCT01806649?

NCT01806649 is sponsored by Prince of Songkla University.

What drugs are being tested in NCT01806649?

Interventions in NCT01806649: BKM120.

What condition does NCT01806649 study?

NCT01806649 studies Esophageal Cancer.

Is NCT01806649 still recruiting?

NCT01806649 is currently terminated. Last updated 11 October 2021.

Last reviewed 2021-10-11 · How we verify

NCT01806649

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

BKM120 in Esophageal Squamous Cell Carcinoma After Failure of First Line Chemotherapy

Terminated Phase 2 Last updated 11 October 2021

What this trial tests

Phase 2 trial testing BKM120 in Esophageal Cancer in 5 participants. Terminated before completion.

Timeline

1 July 2013

Primary endpoint
30 April 2016

30 April 2016

Quick facts

Lead sponsor	Prince of Songkla University
Phase	Phase 2
Status	Terminated
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	5
Start date	1 July 2013
Primary completion	30 April 2016
Estimated completion	30 April 2016
Sites	1 location across Thailand

Drugs / interventions tested

BKM120 — full drug profile →

Conditions studied

Esophageal Cancer — all drugs for Esophageal Cancer →

Sponsor

Prince of Songkla University

Who can join

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

Sponsor's own description

There is a need for more effective therapy for patients with esophageal squamous cell carcinoma who developed disease progression after first line therapy. Currently, there is no standard second-line therapy for this disease. BKM-120 is a pan-PI3K inhibitor currently tested in clinical trials. In a cellular model of oral-esophageal carcinogenesis, it has shown that EGFR overexpression activated PI3/AKT pathway. Therfore, there is interest to see the efficacy and safety of BKM120 in this setting.

Publications & conference data

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

Role of PI3K/AKT pathway in cancer: the framework of malignant behavior.
Jiang N, Dai Q, Su X, Fu J, et al · · 2020 · cited 419× · PMID 32333246 · DOI 10.1007/s11033-020-05435-1
Personalized targeted therapy for esophageal squamous cell carcinoma.
Kang X, Chen K, Li Y, Li J, et al · · 2015 · cited 42× · PMID 26167067 · DOI 10.3748/wjg.v21.i25.7648
Advances in targeted therapies and new promising targets in esophageal cancer.
Belkhiri A, El-Rifai W. · · 2015 · cited 35× · PMID 25593196 · DOI 10.18632/oncotarget.2752
Therapeutic Potency of PI3K Pharmacological Inhibitors of Gastrointestinal Cancer.
Hashemzadeh K, Jokar MH, Sedighi S, Moradzadeh M. · · 2019 · cited 11× · PMID 31049177 · DOI 10.15171/mejdd.2018.122
Concordance between PIK3CA mutations in endoscopic biopsy and surgically resected specimens of esophageal squamous cell carcinoma.
Hatogai K, Fujii S, Kojima T, Daiko H, et al · · 2017 · cited 6× · PMID 28068934 · DOI 10.1186/s12885-016-3041-3

Verify or expand the search:

Other trials of BKM120

Trials testing the same drug.

NCT02220855 — A Study of BKM120 (Buparlisib) in Relapsed or Refractory Thymomas · Phase 2 · completed
NCT02113878 — Phase Ib Study of BKM120 With Cisplatin and XRT in High Risk Locally Advanced Squamous Cell Cancer of Head and Neck · Phase 1 · completed
NCT02159066 — LGX818 and MEK162 in Combination With a Third Agent (BKM120, LEE011, BGJ398 or INC280) in Advanced BRAF Melanoma · Phase 2 · completed
NCT02000882 — STAR Cape+BKM120 MBC With Brain Met · Phase 2 · completed
NCT02088684 — Study of LEE011 With Fulvestrant and BYL719 or BKM120 in Advanced Breast Cancer · Phase 1 · completed

Other recruiting trials for Esophageal Cancer

Currently open trials in the same condition.

NCT07464470 — Comparison of Molecular-Genetic Concordance of the Primary Tumor and Brain Metastases of Gastroesophageal Cancers · recruiting
NCT07431281 — Sonesitatug Vedotin in Combination With Capecitabine With or Without Rilvegostomig in Participants With Advanced or Meta · Phase 3 · recruiting
NCT07448493 — Local Treatment Strategies for Brain Metastases of Gastric and Esophageal Cancer · active not recruiting
NCT07410676 — EBNK-001 Allogeneic NK Cells With Low-Dose IL-15 ± Pembrolizumab in Advanced Solid Tumors · Phase 1, PHASE2 · recruiting
NCT07307560 — High-Flow Nasal Cannula for Preventing Hypoxia During Sedated Endoscopy in High-Risk Obstructive Sleep Apnea Patients · NA · recruiting

Other Prince of Songkla University trials

Trials by the same sponsor.

NCT06841133 — Chinese Art Activities or Combined With Peer Group Participation on Psychological Well Being · NA · not yet recruiting
NCT06837116 — Immunogenicity of an Intradermal Qdenga Vaccine Among Healthy Volunteers · EARLY_PHASE1 · completed
NCT06476652 — Effect of Simple Simulator-based Training on Initial Performance of Novices Iultrasound-guided Adductor Canal Block · enrolling by invitation
NCT07245966 — Pharmacokinetics and Pharmacodynamics of High Dose Ceftriaxone in Patients With Sepsis · completed
NCT06265870 — Specific Versus Empirical Anthelminthic Treatment in Eosinophilia · NA · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT01806649 (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 Prince of Songkla University
Last refreshed: 11 October 2021

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/NCT01806649.

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