Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02239731 | Safety, Tolerability and Efficacy Study of Doxycycline Foam for the Prevention of EGFRI Skin Toxicity in Cancer Patients | PHASE2 | COMPLETED | 24 | — | — | Oct 1, 2014 | Oct 1, 2015 | Feb 27, 2018 | 7 | Israel |
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.
| Arm | Type | Description |
|---|---|---|
| FDX104 (4% Doxycycline) | EXPERIMENTAL | Active ingredient: Doxycycline Concentration: 4% Route: Topical Dosage schedule: Twice daily, morning and evening. Prophylactic treatment to prevent the rash associated with EGFRI treatment. patients will apply a thin layer of the drug twice daily for five weeks to one half of face |
| Placebo foam | PLACEBO_COMPARATOR | Active ingredient: None Route: Topical Dosage schedule: Twice daily, morning and evening. Patients will apply a thin layer of the placebo twice daily for five weeks to the opposite half of the face of which they received active treatment. |
| Name | Type | Description |
|---|---|---|
| FDX104 (4% Doxycycline) | DRUG | FDX104 - 4% or Placebo to be applied twice twice daily during 5 weeks |
Inclusion Criteria: 1. Age 18 years and older 2. Subjects with any cancer receiving Cetuximab or Panitumumab on a weekly or every 2 weeks basis. 3. Scheduled to start Cetuximab or Panitumumab treatment; 4. Males or non-pregnant, non-lactating females who are postmenopausal, naturally or surgically ...