Status:
UNKNOWN
Doxycycline vs Isotretinoin for Acneiform Eruptions of TKI
Lead Sponsor:
Lady Davis Institute
Conditions:
Acneiform Eruptions
Cancer, Treatment-Related
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
Tyrosine Kinase inhibitors (TKIs) have become standard of care in patients with EGFR mutations in non-small cell lung cancer and other EGFR-mutated cancers. However, TKIs are well-known to cause cutan...
Detailed Description
Background and Study Aims: Tyrosine Kinase inhibitors (TKIs) have become standard of care in patients with EGFR mutations in non-small cell lung cancer and other EGFR-mutated cancers. However, TKIs a...
Eligibility Criteria
Inclusion
- Participant must be ≥18 years of age, able to understand the study procedures, and agrees to participate in the study by providing written informed consent
- Participant has histologically- or pathologically-confirmed cancer with a known sensitizing EGFR mutation.
- Participants must have started EGFR-TKI treatment, and subsequently had an acneiform eruption rated moderate or severe per the Leeds scale.
- Participant has an Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2.
- Participant has a life expectancy of at least 3 months.
- Premenopausal participants must use highly effective method of contraception. Female participants are neither pregnant nor breastfeeding
Exclusion
- Absolute contraindications: pregnancy, breastfeeding, drug allergy
- Relative contraindications:
- moderate to severe hypercholesterolemia (total cholesterol \>7.8 mmol/L)
- hypertriglyceridemia (TG \>2.55 mmol/L)
- significant hepatic dysfunction (AST \> 55IU/L, ALT \> 94 IU/L)
- suicidal ideation, pseudotumor cerebri
- refractory nausea or vomiting
- GI pathology that would prevent absorption of oral therapy.
Key Trial Info
Start Date :
September 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2022
Estimated Enrollment :
98 Patients enrolled
Trial Details
Trial ID
NCT04864717
Start Date
September 1 2021
End Date
December 1 2022
Last Update
September 8 2021
Active Locations (1)
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1
Jewish General Hospital
Montreal, Quebec, Canada, H3T 1E2