Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06648096
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-15
Brief Title:
Afatinib in Patients with Fanconi Anemia FA and Advanced Head and Neck Squamous Cell Carcinoma HNSCC
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Phase IbII 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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
AFAN
Brief Summary:
This research study is a phase IbII 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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None