Neoplasms

All Conditions

Symptoms and General Pathology

Carcinoma

Carcinoma, Squamous Cell

Recurrence

Head and Neck Neoplasms

Squamous Cell Carcinoma of Head and Neck

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Neoplasms, Squamous Cell

Abemaciclib represents a selective and potent small molecule CDK4 and CDK6 dual inhibitor with broad antitumor activity in preclinical pharmacology models.(oral class) Patients will be instructed to take Abemaciclib orally at a dose of 200mg bid with a glass of water twice daily, in a fasting state or with a light fat-free meal, and as close as possible to the same time each day

Patients will be instructed to take Abemaciclib orally at a dose of 200mg bid with a glass of water twice daily, in a fasting state or with a light fat-free meal, and as close as possible to the same time each day

Abemaciclib

Bhumsuk Keam Keam

Bhumsuk Keam, MD

Hye Ryun Kim

Hwan Jung Yun

Myung-Ju Ahn

Sung Bae Kim

Hyun Chang

Sang Hoon Chun

InSook Woo

Yoon Ho Ko

Ji Hyung Hong

jung hye kwon

Heui-june Ahn

Yun Gyoo Lee

Keonuk Park

Eun Joo Kang

Seong-Hoon Shin

Tak Yun

Yoon Hee Choi

Keun-Wook Lee

Joo-Hang Kim

JinSoo Kim

Sang-Cheol Lee

Hyun Woo Lee

Min Kyoung Kim

Hyeok Shim

Seung taek Lim

Kyoung Eun Lee

Moon Young Choi

Joohan Lim

In Gyu Hwang

Hyo Jung Kim

Jun Eul Hwang

Ho Jung An

So Yeon Oh

Sang-Gon Park

Hee Kyoung Ahn

Sun Min Lim

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)

This study will be conducted as a treatment arm 4 of the umbrella clinical trial.(NCT03292250)

During or after palliative 1st line platinum based chemotherapy, we will perform prescreening NGS based molecular characterization. The molecular characterization will be done by following three methods.

* NGS : Agilent SureSelect Target Enrichment (245 genes)
* Nanostring nCounter including immune signature
* IHC : PD-L1

The present trial will investigate the efficacy and safety of abemaciclib in patients with recurrent or metastatic HPV (-) HNSCC with genetic alterations of cell cycle pathway who failed to platinum-based therapy. We will also evaluate feasibility and the effect on decision making of next generation sequencing of HNSCC.

During or after palliative 1st line platinum based chemotherapy, we will perform prescreening NGS based molecular characterization.

Molecular tumor board to determine characterization will be held for every patients. Once each patients have relevant genetic pathway, the patients will be allocated each treatment arm

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

Overall Survival is defined as the time from first dose to death due to any cause. Through the follow-up within 30 days after study completion or termination of the last subject, death and date of death will be checked for subject alive during treatment period

number of patients with treatment-related AE as assessed by NCI CTCAE version 4.03

Seoul National University Hospital

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
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	NCT03356587	HNSCC Head and Neck N...	Abemaciclib	20 Years -	Seoul National University Hospital
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	NCT03356587	HNSCC Head and Neck N...	Abemaciclib	20 Years -	Seoul National University Hospital

Spots Global Cancer Trial Database for biomarker driven umbrella trial