NCT03356587 is a Phase 2 clinical trial of Abemaciclib in HNSCC, sponsored by Seoul National University Hospital.

Who is sponsoring NCT03356587?

NCT03356587 is sponsored by Seoul National University Hospital.

What drugs are being tested in NCT03356587?

Interventions in NCT03356587: Abemaciclib.

What condition does NCT03356587 study?

NCT03356587 studies HNSCC, Head and Neck Neoplasms.

Is NCT03356587 still recruiting?

NCT03356587 is currently status unknown. Last updated 29 November 2017.

Last reviewed 2017-11-29 · How we verify

NCT03356587

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

A Biomarker-driven, Open Label, Single Arm, Multicentre Phase II Study of Abemaciclib in Patients With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma Who Failed to Platinum-based Therapy

Status unknown Phase 2 Last updated 29 November 2017

What this trial tests

Phase 2 trial testing Abemaciclib in HNSCC in 32 participants. Status unknown.

Timeline

16 October 2017

Primary endpoint
1 January 2020

31 December 2020

Quick facts

Lead sponsor	Seoul National University Hospital
Phase	Phase 2
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	prevention
Enrollment	32
Start date	16 October 2017
Primary completion	1 January 2020
Estimated completion	31 December 2020
Sites	1 location across South Korea

Drugs / interventions tested

Abemaciclib (abemaciclib) — full drug profile →

Conditions studied

HNSCC — all drugs for HNSCC →
Head and Neck Neoplasms — all drugs for Head and Neck Neoplasms →

Sponsor

Seoul National University Hospital

Who can join

20 and older, any sex, with HNSCC or Head and Neck Neoplasms. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Open, multicenter, single arm, phase II, biomarker driven umbrella trial for head and neck squamous cell carcinoma (FGFR inhibitor, CDK4/6 inhibitor, pan HER inhibitor, PI3K inhibitor, PD1/PD-L1 inhibitor)

Publications & conference data

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

Emerging role of PTEN loss in evasion of the immune response to tumours.
Vidotto T, Melo CM, Castelli E, Koti M, et al · · 2020 · cited 163× · PMID 32327707 · DOI 10.1038/s41416-020-0834-6
CDK 4/6 Inhibitors as Single Agent in Advanced Solid Tumors.
Schettini F, De Santo I, Rea CG, De Placido P, et al · · 2018 · cited 150× · PMID 30631751 · DOI 10.3389/fonc.2018.00608
Therapeutic strategies of different HPV status in Head and Neck Squamous Cell Carcinoma.
Sun Y, Wang Z, Qiu S, Wang R. · · 2021 · cited 43× · PMID 33867833 · DOI 10.7150/ijbs.58077
Genome-wide CRISPR screens of oral squamous cell carcinoma reveal fitness genes in the Hippo pathway.
Chai AWY, Yee PS, Price S, Yee SM, et al · · 2020 · cited 42× · PMID 32990596 · DOI 10.7554/elife.57761
An update: emerging drugs to treat squamous cell carcinomas of the head and neck.
Lee YS, Johnson DE, Grandis JR. · · 2018 · cited 34× · PMID 30376740 · DOI 10.1080/14728214.2018.1543400
Beyond EGFR Targeting in SCCHN: Angiogenesis, PI3K, and Other Molecular Targets.
Saada-Bouzid E, Le Tourneau C. · · 2019 · cited 18× · PMID 30815390 · DOI 10.3389/fonc.2019.00074
Preclinical Head and Neck Squamous Cell Carcinoma Models for Combined Targeted Therapy Approaches.
Schoenwaelder N, Krause M, Freitag T, Schneider B, et al · · 2022 · cited 7× · PMID 35626088 · DOI 10.3390/cancers14102484

Verify or expand the search:

Other trials of Abemaciclib

Trials testing the same drug.

NCT07492641 — BGB-43395 Plus Letrozole Versus CDK4/6i Plus Letrozole for Patients With Advanced or Metastatic HR+/HER2- Breast Cancer · Phase 3 · not yet recruiting
NCT07428018 — Pragmatic Study to Optimize Neoadjuvant Treatment and Surgical De-escalation in HR+/HER2- Early Breast Cancer Using Onco · Phase 2 · not yet recruiting
NCT07191717 — Imlunestrant and Abemaciclib for the Treatment of Estrogen Receptor Positive Breast Cancer in Patients With Minimal Resi · Phase 2 · not yet recruiting
NCT06498648 — Testing the Addition of an Anti-cancer Drug, Abemaciclib, to the Usual Chemotherapy Treatment (Gemcitabine) for Soft Tis · Phase 1, PHASE2 · recruiting
NCT07441369 — Abemaciclib Combined With FOLFOX/FOLFIRI Regimen in Patients With Advanced Colorectal Liver Metastases Cancer · Phase 2 · enrolling by invitation

Other recruiting trials for HNSCC

Currently open trials in the same condition.

NCT07035249 — DCSZ11 in Combination With Standard Therapy in Advanced or Metastatic Solid Tumors · Phase 1, PHASE2 · recruiting
NCT07081984 — Study of TI-0093 Injection With Recurrent/Metastatic HPV-16 Positive Solid Tumors · Phase 1 · recruiting
NCT07182149 — A Phase 1 Study of NRM-823 in Participants With Locally Advanced or Metastatic Refractory Solid Tumors · Phase 1 · recruiting
NCT07106827 — A Study of GV20-0251 in Advanced or Refractory Solid Tumors · Phase 1 · recruiting
NCT07136545 — A Phase I/II Trial of HCB101 in Combination With Pembrolizumab for Patients With Platinum-Refractory, Recurrent or Metas · Phase 1, PHASE2 · recruiting

Other Seoul National University Hospital trials

Trials by the same sponsor.

NCT07262944 — EOI Block in Otoplasty With Rib Cartilage Graft · NA · recruiting
NCT07464210 — Nemtabrutinib, Bortezomib, and Rituximab for WM · Phase 2 · not yet recruiting
NCT07550803 — Effect of Intraoperative Dexamethasone on Early Postoperative Sleep Quality in Patients Undergoing Nasal Surgery · NA · not yet recruiting
NCT07522138 — Home-based Self-exercise in Patients With Parkinson's Disease: A Feasibility Study · NA · not yet recruiting
NCT07476651 — Scout Dose of Resin Microspheres · 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 NCT03356587 (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 Seoul National University Hospital
Last refreshed: 29 November 2017

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/NCT03356587.

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