Study of Afatinib in Advanced Cutaneous Squamous Cell Carcinoma

Part of paid clinical trials in Tampa, Florida.

Sponsor
H. Lee Moffitt Cancer Center and Research Institute
Study ID
NCT05070403
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Afatinib 40 MG — DRUG
    Participants will receive 40 mg Afatinib, once daily.

Study Details

The primary purpose of this study is to find out if Afatinib can help treat participants with advanced cSCC.

Key Dates

Start date
Oct 1, 2021
Status verified
Mar 2026
Primary completion
Feb 28, 2027
Completion
Mar 31, 2028

Study Design

Enrollment
25 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Afatinib Intervention
    Participants will receive afatinib 40 mg once a day. Each cycle is 4 weeks. They will have CT imaging (and/or digital photography) done at baseline and every 8 weeks while on treatment. Participants will have a baseline and on-treatment (at 4 weeks) tumor biopsy, and a biopsy at disease progression if feasible. Patients may remain on treatment as long as they are deriving clinical benefit, until disease progression or intolerable toxicity.

Primary Outcome Measure

Overall Response Rate [ Time Frame: Up to 1 Year ]

Locations (1)

FacilityCityStateZIPSite coordinators
Moffitt Cancer CenterTampaFlorida33612
Maureen Canelo
[email protected]
813-745-4277
Zeynep Eroglu, MD
[email protected]
813-745-7488
Zeynep Eroglu, MD (PRINCIPAL_INVESTIGATOR)

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