A Phase II multicentric, randomised, double-blind, placebo-controlled study of TAR-0520 gel in EGFR inhibitor-induced folliculitis
Prevention of EGFRI-induced folliculitis in colorectal cancer patients treated with ant-EGFR antibodies
A Phase II, multicentric, randomized, double-blind, placebo-controlled, parallel-group study to confirm the good safety profile and to explore the preventative effect of topically applied TAR-0520 gel on folliculitis developed in metastatic colorectal cancer (mCRC) patients treated with monoclonal anti-EGFR antibodies. Approximately 60 mCRC patients will be included in this study and receive either the topical active TAR-0520 gel or its vehicle (same formulation without the active) in a 1:1 ratio. A stratification will ensure that the same proportion of patients treated with cetuximab or panitumumab will be found in the two arms. The treatment schematic will thus include a 7-day treatment period with once-daily applications of the test product followed by a treatment-free period until the initiation of the next chemotherapy cycle (usually 7 days later). The study duration will cover four complete chemotherapy cycles, thus lasting at least 56 days and including four periods of 7 days of test product applications followed by a treatment-free period. The expected duration of the study, from the inclusion of the first subject to the discharge of the last subject, is approximately 21 months. The end date of the clinical trial is defined as the discharge date of the last subject. The expected duration of recruitment (i.e. from the first to the last subject inclusive) is approximately 18 months. Including the selection phase (up to 6 weeks), the maximum duration of participation in the study for a subject will be 14 weeks.
1. Male or female, who is at least 18 years of age or older at the screening visit 2. Clinical diagnosis of metastatic colorectal carcinoma planned to be treated with cetuximab or panitumumab injections as part of the chemotherapy protocol 3. Patients who can understand and sign the Informed Consent Form, can communicate with the investigator, can understand and comply with the requirements of the protocol, and can apply the study gel by himself/herself or have a giver who can apply the products 4. Predicted life expectancy ≥3 months 5. Willing and able to comply with all of the time commitments and procedural requirements of the clinical trial protocol
1. Patient with a medical history of EGFRi treatment in the past 2 years 2. Patient has any underlying physical or psychological medical condition that, in the opinion of the Investigator, would make it unlikely that the patient would comply with the protocol or complete the study per protocol. 3. Any uncontrolled or serious disease, or any medical or surgical condition, that may put the subject at significant risk (according to the Investigator’s judgment) if he/she participates in the clinical trial. 4. Patient has a history of other skin disorders (eg, atopic dermatitis, psoriasis, recurrent skin infections), or a history of illness that, in the opinion of the Investigator, would confound the results of the study 5. Significant skin disease other than EGFRI-induced acneiform lesions within the same body areas planned for study drug application 6. Has a beard that would interfere with administration of study drug and assessment of study endpoints 7. Active infection within the treatment area or in other body areas that requires initiation of systemic antibiotics 8. Known or suspected allergies or sensitivities to any components of any of the study drugs (see Investigator’s Brochure/Product label) 9. Female who is pregnant or lactating 10. Female who intends to conceive a child during the clinical trial