NCT01822613 is a Phase 1 clinical trial of LJM716 in Esophageal Squamous Cell Carcinoma, sponsored by Novartis Pharmaceuticals.

Who is sponsoring NCT01822613?

NCT01822613 is sponsored by Novartis Pharmaceuticals.

What drugs are being tested in NCT01822613?

Interventions in NCT01822613: LJM716, BYL719, Paclitaxel, Docetaxel, Irinotecan.

What condition does NCT01822613 study?

NCT01822613 studies Esophageal Squamous Cell Carcinoma.

Is NCT01822613 still recruiting?

NCT01822613 is currently completed. Last updated 19 December 2020.

Last reviewed 2020-12-19 · How we verify

NCT01822613

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

Study of Safety & Efficacy of the Combination of LJM716 & BYL719 in Patients With Previously Treated Esophageal Squamous Cell Carcinoma (ESCC)

Completed Phase 1 Last updated 19 December 2020

What this trial tests

Phase 1 trial testing LJM716 in Esophageal Squamous Cell Carcinoma in 48 participants. Completed in 3 June 2016.

Timeline

26 July 2013

Primary endpoint
3 June 2016

3 June 2016

Quick facts

Lead sponsor	Novartis Pharmaceuticals
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	48
Start date	26 July 2013
Primary completion	3 June 2016
Estimated completion	3 June 2016
Sites	13 locations across Hong Kong, Belgium, Taiwan, United Kingdom, South Korea, Canada, Singapore, United States

Drugs / interventions tested

LJM716
BYL719
Paclitaxel — full drug profile →
Docetaxel (Docetaxel) — full drug profile →
Irinotecan (irinotecan) — full drug profile →

Conditions studied

Esophageal Squamous Cell Carcinoma — all drugs for Esophageal Squamous Cell Carcinoma →

Sponsor

Novartis Pharmaceuticals — full company profile →

Who can join

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

Sponsor's own description

To study the safety and efficacy of the combination of LJM716 and BYL719 against currently available treatments of physician's choice in previously treated esophageal squamous cell carcinoma patients.

Publications & conference data

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

Revisiting the IGF-1R as a breast cancer target.
Ekyalongo RC, Yee D. · · 2017 · cited 82× · PMID 29152592 · DOI 10.1038/s41698-017-0017-y
HER3 in cancer: from the bench to the bedside.
Gandullo-Sánchez L, Ocaña A, Pandiella A. · · 2022 · cited 71× · PMID 36271429 · DOI 10.1186/s13046-022-02515-x
Mechanisms of Receptor Tyrosine-Protein Kinase ErbB-3 (ERBB3) Action in Human Neoplasia.
Black LE, Longo JF, Carroll SL. · · 2019 · cited 54× · PMID 31351986 · DOI 10.1016/j.ajpath.2019.06.008
A comprehensive review of heregulins, HER3, and HER4 as potential therapeutic targets in cancer.
Mota JM, Collier KA, Barros Costa RL, Taxter T, et al · · 2017 · cited 52× · PMID 29179520 · DOI 10.18632/oncotarget.18467
Development of Effective Therapeutics Targeting HER3 for Cancer Treatment.
Liu X, Liu S, Lyu H, Riker AI, et al · · 2019 · cited 50× · PMID 30930695 · DOI 10.1186/s12575-019-0093-1
Novel Systemic Treatment Modalities Including Immunotherapy and Molecular Targeted Therapy for Recurrent and Metastatic Head and Neck Squamous Cell Carcinoma.
Ghosh S, Shah PA, Johnson FM. · · 2022 · cited 47× · PMID 35887235 · DOI 10.3390/ijms23147889
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
Emerging anti-cancer antibodies and combination therapies targeting HER3/ERBB3.
Gaborit N, Lindzen M, Yarden Y. · · 2016 · cited 40× · PMID 26529100 · DOI 10.1080/21645515.2015.1102809

Verify or expand the search:

Other trials of LJM716

Trials testing the same drug.

NCT02167854 — Open-Label Study Evaluating the Safety and Tolerability of LJM716, BYL719 and Trastuzumab in Patients With Metastatic HE · Phase 1 · completed
NCT01602406 — Phase I Study LJM716 Combined With Trastuzumab in Patients With HER2 Overexpressing Metastatic Breast or Gastric Cancer · Phase 1 · completed

Other recruiting trials for Esophageal Squamous Cell Carcinoma

Currently open trials in the same condition.

NCT07503808 — A Study of IDE034 in Adult Participants With Locally Advanced/Metastatic Solid Tumors Types · Phase 1 · recruiting
NCT07385001 — A Prospective, Multicenter, Phase Ib/II Trial of Ivonescimab (AK112) Combined With Albumin-Paclitaxel and Cisplatin as N · Phase 1, PHASE2 · recruiting
NCT07217171 — A Study Evaluating the Safety, Efficacy, and Pharmacokinetics (PK) of EVOLVE104 in Participants With Advanced Urothelial · Phase 1 · recruiting
NCT07109726 — A Phase 1/2 Trial of TER-2013 in Patients With Solid Tumors Harboring AKT/PI3K/PTEN Pathway Alterations · Phase 1, PHASE2 · recruiting
NCT07090499 — A Study to Learn About the Study Medicine Called PF-08046876 in People With Advanced Solid Tumors · Phase 1 · recruiting

Other Novartis Pharmaceuticals trials

Trials by the same sponsor.

NCT07498335 — Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Atrasentan in Pediatric Patients With Primary · Phase 3 · not yet recruiting
NCT07489573 — Study of Efficacy and Safety of Secukinumab in Chinese Adult Patients With Moderate to Severe Hidradenitis Suppurativa · Phase 4 · not yet recruiting
NCT07484269 — PULSE Registry: for Patients Receiving Lutetium (177Lu) Vipivotide Tetraxetan · not yet recruiting
NCT07416162 — A Study of Iptacopan in Korean Patients With Paroxysmal Nocturnal Hemoglobinuria or C3 Glomerulopathy · not yet recruiting
NCT07387926 — Safety and Efficacy of Asciminib in Pediatrics and Young Adults With Relapse/Refractory (r/r) Philadelphia Positive (Ph+ · Phase 1, PHASE2 · not yet 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 NCT01822613 (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 Novartis Pharmaceuticals
Last refreshed: 19 December 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/NCT01822613.

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