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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
EU CTIS ID: 2024-511477-29-00
What this study is testing
To investigate the 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. Primary endpoint for efficacy will be objective response rate (ORR).
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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. Aspartateaminotransferase(AST)andalanineaminotransferase(ALT)<2.5x 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*(definedasatleast1yearwithoutanymenses)prior P to screening , or Documented surgically sterile (e.g.hysterectomy, bilateral salpingectomy, bilateral oophorectomy, or bilateral tubal occlusion). *Those who are amenorrheic due toanalternativemedicalcauseare not considered postmenopausal and must follow the criteria for childbearing potential subjects. OR b. If of childbearing potential: i. Agreenottotrytobecomepregnantduringthestudyandforatleast1 months after the final study drug administration, ii. Andhaveanegativeurineorserumpregnancytestwithin7daysprior 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 inlinewiththe usual preferred lifestyle of the patient)orconsistentlyuseacondom plus1formofhighlyeffectivebirthcontrol(Appendix12)perlocally 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 thestudy period, and for at least 1 month after the final study drug administration.
You likely can't join if
- 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.
See the full eligibility criteria
Who can join
- 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. Aspartateaminotransferase(AST)andalanineaminotransferase(ALT)<2.5x 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*(definedasatleast1yearwithoutanymenses)prior P to screening , or Documented surgically sterile (e.g.hysterectomy, bilateral salpingectomy, bilateral oophorectomy, or bilateral tubal occlusion). *Those who are amenorrheic due toanalternativemedicalcauseare not considered postmenopausal and must follow the criteria for childbearing potential subjects. OR b. If of childbearing potential: i. Agreenottotrytobecomepregnantduringthestudyandforatleast1 months after the final study drug administration, ii. Andhaveanegativeurineorserumpregnancytestwithin7daysprior 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 inlinewiththe usual preferred lifestyle of the patient)orconsistentlyuseacondom plus1formofhighlyeffectivebirthcontrol(Appendix12)perlocally 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 thestudy 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 birth control through out the study period and for at least 1month 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 (SeeSection4.1.3.3).
- Histologically or cytologically confirmed unresectable or locoregionally advanced squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, larynx, nasopharynx,paranasalsinusesorsalivaryglands.Patientswithdistalmetastasis(M 1, th AJCC 8 ed.) are also eligible.
- Tumor not a candidate for resection prior to Afatinib due to technical inability to resect (tumor fixation/invasionintheskullbase,cervicalvertebrae,nasopharynxor fixed lymph nodes) and / or low surgical cure [T3-T4, N2-N3; , AJCC 8th ed.]).
- Patients should not be candidates for other curative standard treatment options including radiotherapy, chemotherapy or immunotherapy.
- Patients must have at least 1 measurable lesion by computed tomography (CT) scan or magnetic resonance imaging (MRI) as defined by RECIST v1.1 (Appendix 4).
- Previous anticancer treatment isallowed if itends 6weeks or 5half-lives,whichever is shorter, before the expected date of start of the study treatment.
- Previous locorregional treatments such as radiotherapy are allowed.
What rules you out
- 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.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.