AFAN trial. Phase Ib/II study to investigate the safety and efficacy of Afatinib when administered as therapy in Fanconi anemia patients with unresectable and / or metastatic locoregionally advanced squamous cell carcinoma of the oral cavity, oropharynx or hypopharynx or larynx

Phase 1

• Conditions: Patients diagnosed with unresectable and / or metastatic locoregionally advanced squamous cell carcinoma of the oral cavity, oropharynx or hypopharynx or larynx secondary to Fanconi anemia.; MedDRA version: 26.1Level: PTClassification code: 10023856Term: Laryngeal squamous cell carcinoma Class: 100000004864; MedDRA version: 21.1Level: PTClassification code: 10031112Term: Oropharyngeal squamous cell carcinoma Class: 100000004864; MedDRA version: 26.1Level: PTClassification code: 10041857Term: Squamous cell carcinoma of the oral cavity Class: 100000004864; MedDRA version: 26.1Level: PTClassification code: 10041849Term: Squamous cell carcinoma of the hypopharynx Class: 100000004864; MedDRA version: 20.0Level: LLTClassification code: 10055206Term: Fanconi's anemia Class: 10010331; Therapeutic area: Diseases [C] - Neoplasms [C04]; Therapeutic area: Not possible to specify

• Registration Number: CTIS2024-511477-29-00
• Lead Sponsor: Fundacio Institut De Recerca De L Hospital De La Santa Creu I Sant Pau

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-04-23
• Last Update Posted: 21 August 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

Written informed consent according to local guidelines, must be signed and dated by the participant and investigator prior to performing any protocol procedure., Eastern? ?Cooperative? ?Oncology? ?Group? ?(ECOG)? ?performance? ?status? ? ?2? ?at? ?inclusion? ?(?A ? ppendix 11??).?, Adequate organ and bone marrow functions, as defined below:? a? .? ?Neutrophils 1000 cells / microliter.? ?b.? ?Platelets > 50,000 cells / microliter.? ?c.? ?Hemoglobin > 8 g / dL? ?d.? ?Creatinine < 1.5 x upper limit normal (ULN) with clearance > 50 mL / min.? ?e.? ?Total? ?bilirubin? ?<? ?1.5? ?x? ?ULN.? ?Note:? ?patients? ?with? ?Gilbert's? ?may? ?be? ?included? ?with bilirubin <2 x ULN.? ?f.? ?Aspartate??aminotransferase??(AST)??and??alanine??aminotransferase??(ALT)??<??2.5??x? ?ULN or < 5 ULN if liver metastases are present.? ?g.? ?International normalized ratio (INR) and prothrombin time (PT) <1.5 x ULN.?, ?Female patients must either:? ?a.? ?Be of nonchildbearing potential:? ?i.? ?ii.? ? ostmenopausal??*(defined??as??at??least??1??year??without??any??menses)??prior? P ?to screening , or? ?Documented? ?surgically? ?sterile? ?(e.g.hysterectomy,? ?bilateral? ?salpingectomy, bilateral oophorectomy, or bilateral tubal occlusion).? ?*Those? ?who? ?are? ?amenorrheic? ?due? ?to??an??alternative??medical??cause??are? ?not? ?considered? ?postmenopausal? ?and? ?must? ?follow? ?the? ?criteria? ?for? ?childbearing potential subjects.? ?OR? ?b.? ?If of childbearing potential:? ?i.? ?Agree??not??to??try??to??become??pregnant??during??the??study??and??for??at??least??1? ?months after the final study drug administration,? ?ii.? ?And??have??a??negative??urine??or??serum??pregnancy??test??within??7??days??prior? ?to? ?Day? ?1? ?(females? ?with? ?false? ?positive? ?results? ?and? ?documented? ?verification? ?of? ?negative? ?pregnancy? ?status? ?are? ?eligible? ?for? ?participation),? ?iii.? ?And? ?if? ?heterosexually? ?active,? ?agree? ?to? ?abstinence? ?(if? ?in??line??with??the? ?usual? ?preferred? ?lifestyle? ?of? ?the? ?patient)??or??consistently??use??a??condom? ?plus??1??form??of??highly??effective??birth??control??(??Appendix??12??)??per??locally? ?accepted? ?standards? ?starting? ?at? ?screening? ?and? ?throughout? ?the? ?study? ?period? ?and? ?for? ?at? ?least? ?1? ?month? ?after? ?the? ?final? ?study? ?drug? ?administration.?, Female ??patients ??must ??agree?? not ??to?? breastfeed or ??donate ??ovules ??starting? ?at ??screening?? and? ?throughout? ?the? ?study? ?period,? ?and? ?for? ?at? ?least? ?1? ?month? ?after? ?the? ?final? ?study? ?drug? ?administration.?, ?Male? ?patients? ?must? ?not? ?donate? ?sperm? ?starting? ?at? ?screening? ?and? ?throughout? ?the??study? ?period, and for at least 1 month after the final study drug administration.?, Male? ?patients? ?with? ?a? ?partner? ?with? ?childbearing? ?potential,? ?or? ?who? ?is? ?pregnant? ?or? ?breast feeding?? must?? agree ??to ??abstinence?? or ??use ?? a ??condom? ?plus ??1 ??form ??of ??highly?? effective b?irth ??control? ?through out ??the ??study?? period?? and? ?for ??at ??least ??1??month?? after?? the ??final ??study? ?drug administration.?, Patient? ?agrees? ?not ??to?? participate ??in ??another?? interventional?? study?? while ??on ??treatment ??in? ?the present study.?, Patient is = 18 years of age.?, ?Confirmed diagnosis of Fanconi anemia (See??Section??4.1.3.3??).?, Histologically? ?or? ?cytologically? ?confirmed? ?unresectable? ?or? ?locoregionally? ?advanced? ?squamous? ?cell? ?carc

Exclusion Criteria

Patients who are candidates for surgery with curative intent are not eligible., Gastrointestinal disorders that may interfere with the absorption of the study drug or chronic diarrhea., Patient has known hypersensitivity to afatinib or to any excipient contained in the drug formulation., Female patients who are or intend to be pregnant or breastfeeding during their participation in the study or 1 month after the final study drug administration., Patients unable to comply with the protocol as determined by the investigator., The patient is currently participating in another clinical trial that would interfere with the radiological imaging schedule or any other determinations required in this protocol., Patient has other underlying medical conditions that, in the opinion of the investigator, would impair the ability of the patient to receive or tolerate the planned treatment and follow-up., Patients with psychiatric disorders that may interfere with monitoring., Less than two weeks from surgical resection or other major surgical procedure at start of treatment. Planned surgery for other diseases., Previous treatment with EGFR small molecule inhibitors, EGFR inhibitory antibodies and / or any investigational agents for the treatment of HNSCC within 4 weeks prior to the selection was not allowed. Note: Previous treatment with chemotherapy and/or radiotherapy is allowed., Patient must have recovered from any previous treatment toxicity to Grade = 2., Existence of any other intercurrent malignant disease is not allowed within the previous 2 years to inclusion. Note: Patients with non melanoma skin cancer, curatively treated localized prostate cancer, or carcinoma in situ of any type (if complete resection was performed) are allowed., Active severe infectious disease in the 4 weeks prior to the initiation of study treatment, including human immunodeficiency virus (HIV) infection or chronic Hepatitis B or C., Patient has documented history of a cerebral vascular event (stroke or transient ischemic attack), or the following criteria for cardiac disease: a. Myocardial infarction or unstable angina pectoris within 6 months of enrollment. b. History of serious ventricular arrhythmia (ie, ventricular tachycardia or ventricular fibrillation), high-grade atrioventricular block, or other cardiac arrhythmias requiring antiarrhythmic medications (except for atrial fibrillation that is well controlled with antiarrhythmic medication); history of QT interval prolongation. c. New York Heart Association (NYHA) class III or greater congestive heart failure or left ventricular ejection fraction of < 40%., Participants with QTc interval (corrected) > 470 msec at screening., History of interstitial lung disease requiring corticosteroids or pneumonitis.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified