Actively Recruiting
Afatinib in Patients with Fanconi Anemia (FA) and Advanced Head and Neck Squamous Cell Carcinoma (HNSCC)
Led by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau · Updated on 2024-11-20
25
Participants Needed
2
Research Sites
212 weeks
Total Duration
On this page
Sponsors
F
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Lead Sponsor
M
MFAR Clinical Research S.L.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Afatinib in Patients with Fanconi Anemia (FA) and Advanced Head and Neck Squamous Cell Carcinoma (HNSCC)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Written informed consent signed and dated before any study procedures
- Age 18 years or older
- Confirmed diagnosis of Fanconi anemia
- Histologically or cytologically confirmed unresectable or locoregionally advanced squamous cell carcinoma in head and neck areas including oral cavity, oropharynx, hypopharynx, larynx, nasopharynx, paranasal sinuses, or salivary glands
- Tumor not operable due to technical reasons or low chance of surgical cure
- At least one measurable lesion by CT or MRI as per RECIST v1.1
- Previous anticancer treatments allowed if ended at least 6 weeks or 5 half-lives before study start
- Previous local treatments such as radiotherapy allowed
- ECOG performance status less than 2 at inclusion
- Adequate organ and bone marrow function meeting specified blood count and chemistry levels
- Female participants must be non-childbearing or agree to pregnancy prevention measures during and for at least 1 month after treatment
- Female participants must agree not to breastfeed or donate eggs during study and for 1 month after
- Male participants must not donate sperm during study and for 1 month after
- Male participants with partners of childbearing potential must agree to effective contraception during and for 1 month after study
- Agreement not to participate in other interventional studies during treatment
You will not qualify if you...
- Candidates for surgery with curative intent
- Within 2 weeks of major surgery or planned surgery for other diseases
- Previous treatment with EGFR inhibitors or investigational agents for HNSCC within 4 weeks
- Not recovered from previous treatment toxicity to Grade 2 or less
- Other active cancers in past 2 years except certain treated skin, prostate, or carcinoma in situ
- Severe active infections including HIV or chronic hepatitis B or C within 4 weeks
- History of stroke, serious heart conditions, or specific cardiac arrhythmias
- QTc interval over 470 msec at screening
- History of interstitial lung disease or pneumonitis
- Gastrointestinal conditions affecting drug absorption or chronic diarrhea
- Known allergy to Afatinib or its ingredients
- Pregnant or breastfeeding females or those intending pregnancy during or 1 month after study
- Unable to comply with protocol requirements
- Participation in conflicting clinical trials
- Other medical or psychiatric conditions impairing treatment or monitoring
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Medizinische Hochschule Hannover
Hanover, Germany
Not Yet Recruiting
2
Hospital de la Santa Creu i Sant Pau
Barcelona, Catalonia, Spain
Actively Recruiting
Research Team
A
A Responsible Person Designated by the Sponsor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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