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New treatment option for Fanconi Anemia
Official title Afatinib in Patients With Fanconi Anemia (FA) and Advanced Head and Neck Squamous Cell Carcinoma (HNSCC)
ClinicalTrials.gov ID: NCT06648096
What this study is testing
What is Afatinib?
Afatinib is an investigational medicine, being studied as a potential treatment for fanconi anemia.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This research study is a phase Ib/II, single-arm, non-randomized, non-blind, multicenter study designed to determine whether Afatinib is effective and safe in patients with locoregionally unresectable and / or metastatic HNSCC with Fanconi Anemia. The main hypothesis, based on preclinical evidence, is that treatment with afatinib, an epithelial growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI), could be an effective treatment option to control cancer for patients with FA - HNSCC.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
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...
- Patient is ≥ 18 years of age.
- Confirmed diagnosis of Fanconi anemia.
- Histologically or cytologically confirmed unresectable or locoregionally advanced squamous cell carcinoma of the oral cavity, oropharynx...
- Tumor not a candidate for resection prior to Afatinib due to technical inability to resect (tumor fixation / invasion in the skull base, cervical...
You likely can't join if
- Patients who are candidates for surgery with curative intent are not eligible.
- 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...
- 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...
- Active severe Severe infectious disease in the 4 weeks prior to the initiation of study treatment, including . Known human immunodeficiency virus...
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.
- Patient is ≥ 18 years of age.
- Confirmed diagnosis of Fanconi anemia.
- Histologically or cytologically confirmed unresectable or locoregionally advanced squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, larynx, nasopharynx, paranasal sinuses or salivary glands. Patients...
- Tumor not a candidate for resection prior to Afatinib due to technical inability to resect (tumor fixation / invasion in the skull base, cervical vertebrae, nasopharynx or fixed lymph nodes) and / or low surgical cure...
- Patients must have at least 1 measurable lesion by computed tomography (CT) scan or magnetic resonance imaging (MRI) as defined by RECIST v1.1.
- Previous anticancer treatment is allowed if it ends 6 weeks or 5 half-lives, whichever is shorter, before the expected date of start of the study treatment.
- Previous locoregional treatments such as radiotherapy are allowed.
- Eastern Cooperative Oncology Group (ECOG) performance status \< 2 at inclusion.
- Adequate organ and bone marrow functions, as defined below:
- Neutrophils \> 1000 cells / microliter.
- Platelets \> 50,000 cells / microliter.
- Hemoglobin \> 8 g / dL
- Creatinine \ 50 mL / min.
- Total bilirubin \< 1.5 x ULN. Note: patients with Gilbert's may be included with bilirubin \<2 x ULN.
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \< 2.5 x ULN or \< 5 ULN if liver metastases are present.
- International normalized ratio (INR) and prothrombin time (PT) \<1.5 x ULN.
- Female patients must either:
- Be of non-childbearing potential: Postmenopausal \ (defined as at least 1 year without any menses) prior to screening , or Documented surgically sterile (e.g.hysterectomy, bilateral salpingectomy, bilateral...
- If of childbearing potential: Agree not to try to become pregnant during the study and for at least 1 months after the final study drug administration, And have a negative urine or serum pregnancy test within 7 days...
- 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 breastfeeding must agree to abstinence or use a condom plus 1 form of highly effective birth control throughout the study period and for at...
- Patient agrees not to participate in another treatment study while on treatment in the present study.
What rules you out
- Patients who are candidates for surgery with curative intent are not eligible.
- 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...
- 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...
- Active severe Severe infectious disease in the 4 weeks prior to the initiation of study treatment, including . Known 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:
- Myocardial infarction or unstable angina pectoris within 6 months of enrollment.
- History of serious ventricular arrhythmia (ie, ventricular tachycardia or ventricular fibrillation), high-grade atrioventricular block, or other cardiac arrhythmias requiring antiarrhythmic medications (except for...
- 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Hanover, Germany
- Barcelona, Catalonia, Spain
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, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hanover, Germany; Barcelona, Catalonia, Spain. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.