The purpose of this study is to evaluate the safety, tolerability and efficacy of FDX104 Antibiotic Foam in the prevention of EGFRI skin toxicity in cancer patients receiving Cetuximab or Panitumumab.
This is a phase II multicenter, randomized, double blind, vehicle controlled clinical study to evaluate the safety, tolerability and efficacy of Doxycycline Foam 4% for the prevention of Epidermal Growth Factor Receptor Inhibition Skin Toxicity, to Subjects with Cancer Receiving Cetuximab or Panitumumab on a weekly or every 2 weeks basis. The study consists of a screening visit, a treatment period where patients will be treated topically on the face twice daily for 5 weeks. A post-treatment follow up visit (4 weeks after end of treatment), will be performed only for subjects who have experienced unresolved possibly-related or related adverse events at the end of the treatment. Seven days after randomization and study drug initiation, subjects will start their EGFRI treatment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
24
FDX104 - 4% or Placebo to be applied twice twice daily during 5 weeks
Soroka Medical Center
Beersheba, Israel
Rambam Medical Center
Haifa, Israel
Hadassah Medical Center
Jerusalem, Israel
Rabin Medical Center
Petah Tikva, Israel
To investigate the safety and tolerability of FDX104 in cancer patients receiving EGFRI
To demonstrate the safety and tolerability of FDX104 in terms of skin tolerability, adverse events, serious adverse events and vital signs in subjects with advanced cancer treated by EGFRI.
Time frame: 9 weeks
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Assaf Harofeh medical center
Rishon LeZiyyon, Israel
Sourasky medical center
Tel Aviv, Israel
Sheba medical center
Tel Litwinsky, Israel