Evaluation of ABEMACICLIB Monotherapy in Patients With Locally Advanced/Metastatic Head and Neck Cancer After Failure of Platinum and Cetuximab or Anti-EGFR-based Therapy and Harboring an Homozygous Deletion of CDKN2A, and/or an Amplification of CCND1 and/or of CDK6

PHASE2CompletedINTERVENTIONAL
Enrollment

25

Participants

Timeline

Start Date

February 5, 2018

Primary Completion Date

November 5, 2022

Study Completion Date

December 5, 2022

Conditions
Head and Neck CancerAdvanced CancerMetastatic Cancer
Interventions
DRUG

Abemaciclib

"400mg/day with 2 doses of 200mg 12-hour apart For each 28-day cycle, a total of 56 doses of study drug will be dispensed.~Route of administration : oral~Duration of treatment until the patient experiences an unacceptable toxicity or symptomatic deterioration attributed to disease progression as determined by the investigator after an integrated assessment of radiographic data and clinical status or withdrawal of consent."

Trial Locations (3)

33075

Hôpital Saint-André, Bordeaux

69373

Centre Léon Bérard, Lyon

06189

Centre Antoine Lassagne, Nice

All Listed Sponsors
lead

Centre Leon Berard

OTHER

NCT03356223 - Evaluation of ABEMACICLIB Monotherapy in Patients With Locally Advanced/Metastatic Head and Neck Cancer After Failure of Platinum and Cetuximab or Anti-EGFR-based Therapy and Harboring an Homozygous Deletion of CDKN2A, and/or an Amplification of CCND1 and/or of CDK6 | Biotech Hunter | Biotech Hunter