Research of Biomarkers of Activity and Efficacy of BIBW2992 in Untreated Non-metastatic HNSCC Patients

• Status: Active, not recruiting
• Trial end date: 2021-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to identify predictive and pharmacodynamic biomarkers of activity and efficacy of pre-operative Afatinib (BIBW2992) in untreated non-metastatic head and neck squamous cell carcinoma patients

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: UNICANCER
• Treatments: Afatinib

Criteria

Inclusion Criteria:

• Age > 18 years

• Histologically or cytologically confirmed squamous cell carcinoma of the oral cavity, oropharynx, larynx or hypopharynx, previously untreated, amenable to curative treatment with surgery. Patients with a diagnosis of SCCHN of occult primary may be enrolled only with the agreement of the lead investigator upon review of the relevant clinical records

• T2-4N0-2 tumors (except T2N0 endolaryngeal tumors)

• Absence of metastases determined by PET CT scan

• Planned date of surgery allowing the patient to receive between 21 and 28 days of treatment

• ECOG performance status ≤ 2

• Adequate bone marrow function (absolute neutrophil count > 1,000 cells/mm³, platelets > 75,000 cells/mm³)

• Adequate liver function (total bilirubin ≤ 1.5 x UNL [upper normal limit], AST or ALT ≤ 3 x UNL)

• Adequate renal function (serum creatinine ≤ 1.5 x UNL)

• Adequate cardiac function (a normal left ventricular ejection fraction [LVEF] of ≥ 50% as measured by MUGA scan or echocardiogram within 4 weeks prior to start of study treatment)

• Potentially reproductive patients must agree to use an effective contraceptive method while on treatment

• Women of childbearing potential must have a negative serum beta-HCG pregnancy test within 7 days prior of enrollment and/or urine pregnancy 48 hours prior to the administration of the first study treatment

• Patients must be able to swallow tablets

• Patients must be willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures

• Patients must be affiliated to a Social Security System

• Patient information and written informed consent form signed

Exclusion Criteria:

• Primary site of head and neck carcinoma in nasopharynx, or skin

• T1N0 tumors and T2N0 endolaryngeal tumors

• Patients not candidate for primary curative surgery

• Planning of surgery not allowing the patient to receive 21 to 28 days of treatment

• Patients receiving other anti-cancer medication such as chemotherapy, immunotherapy, biologic therapy or hormonal therapy (other than leuprolide or other GnRH agonists) within 30 days prior to the first dose of study drug and while on study treatment.

• Patients receiving other anti-cancer non-drug therapies: radiation, or tumor embolization within 4 weeks prior to the first dose of study drug and while on study treatment.

• Patient being treated with anti-vitamin K (AVK). Low molecular weight heparin (LMWH) is allowed.

• Patient with uncontrolled infection

• Patients with other concurrent severe and/or uncontrolled medical disease which could compromise participation in the study, including uncontrolled diabetes,

• Clinically relevant cardiovascular abnormalities, as judged by the investigator, such as, but not limited to, uncontrolled hypertension, congestive heart failure NYHA classification > III, unstable angina, myocardial infarction within six months prior to randomisation, or poorly controlled arrhythmia, chronic liver or renal disease, severely impaired lung function

• Significant or recent acute gastrointestinal disorders with diarrhea as a major symptom e.g. Crohn's disease, malabsorption or CTCAE grade >1 diarrhea of any etiology at randomisation

• Known pre-existing Interstitial Lung Disease (ILD)

• Patients requiring comedication with potent P-gp inhibitors (including Cyclosporin, Erythromycin, Ketoconazole, Itraconazole, Quinidine, Phenobarbital salt with Quinidine, Ritonavir, Valspodar, Verapamil) or inducers (including St John's wort, rifampicin)

• Patients with a known HIV, active hepatitis B and/or C infection

• Pregnant women, women who are likely to be pregnant or are breast-feeding

• Patients with any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial

• Patients who received any other investigational drugs within 30 days prior to the screening visit and/or during the study

• Patients unwilling to participate in the biological investigations

• Individually deprived of liberty or placed under the authority of a tutor