An Phase II trial aiming to evaluate the clinical interest 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 - ABOR

Centre Léon Bérard0 sites25 target enrollmentSeptember 8, 2017

ConditionsPatients with locally advanced/metastatic head and neck cancer after failure of platinum and cetuximab or anti-EGFR-based MedDRA version: 20.0Level: PTClassification code 10067821Term: Head and neck cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Patients with locally advanced/metastatic head and neck cancer after failure of platinum and cetuximab or anti-EGFR-based
Sponsor: Centre Léon Bérard
Enrollment: 25
Status: Active, not recruiting
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

September 8, 2017

End Date

TBD

Last Updated

8 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

Centre Léon Bérard

Eligibility Criteria

Inclusion Criteria

•INCLUSION CRITERIA
•I1\.Male or female patients aged \= 18 years at time of inform consent signature.
•I2\.Histologically proven metastatic or locally advanced HNSCC (oropharynx, oral cavity, hypopharynx and larynx). Patients with cancer of nasopharynx (i.e. cavum cancer) are not eligible.
•I3\.Availability of a representative formalin\-fixed paraffin\-embedded (FFPE) primary and/or metastatic tumor tissue with an associated pathology report for molecular screening:
•\-Either an archival block
•\-Either a dedicated freshly collected tumor biopsy.
•I4\.Documented CDKN2A homozygous deletion and/or CCND1 amplification and/or CDK6 amplification before C1D1\.
•Note: This molecular pre\-screening will be centralized at the CGH platform of CLB using pre\-treatment FFPE tumor sample.
•Note: This molecular pre\-screening can be performed for non\-progressive patient but study drug treatment cannot be initiated until confirmed PD according to RECIST criteria..
•I5\.HPV negative tumor status must be documented before C1D1\.

Exclusion Criteria

•NI1\.Cancer disease considered curable with surgery or radiotherapy.
•NI2\.Patient with a concurrent malignancy or has a malignancy within 3 years of study enrollment (with the exception of adequately treated basal or squamous cell carcinoma or non\-melanomatous skin cancer).
•NI3\.Patient with impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of abemaciclib (e.g., ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, or small bowel resection).
•NI4\.Patient has other concurrent severe and/or uncontrolled medical condition that would, in the investigator’s judgment contraindicate her participation in the clinical study (for example, history of major surgical resection involving the stomach or small bowel, or preexisting Crohn’s disease or ulcerative colitis).
•NI5\.Persisting significant toxicities related to prior treatments i.e. \= Grade 2 AE according to CTCAE V4\.03 except alopecia (any grade) and biological values as defined in inclusion criteria.
•NI6\.Hypersensitivity to the active substance or excipient of study drug
•NI7Have received prior treatment with any CDK4/6 inhibitor (or participated in any CDK4/6 inhibitor clinical trial for which treatment assignment is still blinded).
•NI8\.Patient has received treatment with a drug that has not received regulatory approval for any indication within:
•\-14 days of C1D1 for non myelosuppressive agent or
•\-21 days of C1D1 for a myelosuppressive agent.