Status:
COMPLETED
DWP708 for Treating Epidermal Growth Factor Receptor Inhibitor Related Skin Toxicities
Lead Sponsor:
Daewoong Pharmaceutical Co. LTD.
Conditions:
Rash Acneiform
Eligibility:
All Genders
19+ years
Phase:
PHASE2
Brief Summary
A Multi-center, Randomized, Double-blind, Placebo-controlled, Therapeutic Exploratory, Phase II Clinical Trial for the Efficacy Investigation and Safety Evaluation of DWP708 for Treating Rash Acneifor...
Detailed Description
All the patients had Grade ≥2 ERSEs according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI-CTCAE) v. 5.0
Eligibility Criteria
Inclusion
- Age: older than 19
- Eastern Cooperative Oncology Group (ECOG) performance status 0 -2
- Patients who have Rash acneiform Gr≥2 (NCI CTCAE v5.0)
- Patients who are currently administering EGFR TKI or EGFR mAb
Exclusion
- Known allergies, hypersensitivity, or intolerance to study drugs, chemotherapy drugs using this clinical trial
- Patients with a history of topical medication
- Steroids within 3 days prior to baseline visit
- Antihistamine, Antipruritic agents, Antibiotics agents within 1 week prior to baseline visit
- Tacrolimus, Pimecrolimus within 2 weeks prior to baseline visit
Key Trial Info
Start Date :
May 2 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 28 2023
Estimated Enrollment :
96 Patients enrolled
Trial Details
Trial ID
NCT05378360
Start Date
May 2 2022
End Date
December 28 2023
Last Update
April 4 2024
Active Locations (1)
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1
Dong-A University Hospital
Busan, South Korea, 49201