Status:
UNKNOWN
Crisaborole Ointment for Skin Toxicity Induced by Cetuximab
Lead Sponsor:
Sun Yat-sen University
Conditions:
Metastatic Colorectal Cancer
Cetuximab
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This is a prospective, single-arm, phase II clinical trial that will enroll metastatic colorectal cancer patients with Cetuximab-Related Skin Toxicity, who will receive crisaborole ointment twice dail...
Detailed Description
The efficacy of cetuximab has been demonstrated in treating metastatic colorectal cancer (mCRC). Skin toxicities, especially acneiform eruption, are the major side effects associated with cetuximab, w...
Eligibility Criteria
Inclusion
- Diagnosed mCRC and undergoing Cetuximab treatment;
- ≥2 grade EGFR inhibitor-related acneiform eruption, evaluated by National Cancer Institute (NCI) Common Terminology Criteria Adverse Events (CTCAE）5.0;
- Age 18 years and older；
- ECOG performance status 0-2.；
- Bone marrow ,brain, heart, kidney and other organ function well;；
- Expected survival time more than 3 months;
Exclusion
- The presence of any active skin disease；
- Undergoing any current hormone therapy for any other disease;
- Prior allergic reaction or severe intolerance to crisaborole ointment
Key Trial Info
Start Date :
August 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
33 Patients enrolled
Trial Details
Trial ID
NCT06118047
Start Date
August 1 2023
End Date
December 31 2025
Last Update
November 7 2023
Active Locations (1)
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1
WeiWei Xiao
Guangzhou, Guangdong, China, 510060