Study of Benralizumab in People With Skin Side Effects Caused by Cancer Therapies (NCT04552288) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Study of Benralizumab in People With Skin Side Effects Caused by Cancer Therapies
United States51 participantsStarted 2020-09-16
Plain-language summary
The purpose of this study is to find out whether the study drug benralizumab is a safe treatment that can reduce the skin side effects caused by cancer treatment by reducing the level of eosinophils in your blood. Reducing the skin side effects of your cancer treatment may improve quality of life and allow participants to continue to receive their usual cancer treatment.
Who can participate
Age range18 Years – 85 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patients must have pathologically or cytologically confirmed solid or hematologic cancers.
OR
* Patient is receiving alpelisib for PIK3CA-Related Overgrowth Spectrum disorder.
* Female and male aged 18 to 85 years, inclusively, at the time of Week 0/Day 1 of treatment.
* Patients must have a therapy-related CTCAE grade 2/3 (See Appendix A)cutaneous adverse event defined as any cutaneous reaction listed below and blood eosinophil counts of at least .3 K/mcl.
* Rash maculo-papular
* Bullous dermatitis
* Pruritus
* Urticaria
* Eczema
* Patients must plan to continue on culprit drugs (cancer patients).
* Patients planning to receive alpelisib indicated for PIK3CA-Related Overgrowth
Spectrum disorder OR patients receiving immunotherapy and/or targeted therapy, including but not limited to the following agents, will be eligible for inclusion:
* Immunotherapies: ipilimumab, nivolumab, pembrolizumab, avelumab, durvalumab, atezolizumab tremelimumab.
* Targeted therapies: trastuzumab, pertuzumab, alpelisib, osimertinib, everolimus, temsirolimus, sorafenib, regorafenib.
* Patients using topicals/orals for indication of skin rash/pruritus for at least 7 days should continue using these drugs for the study duration
* Adequate bone marrow, liver and renal function:
* Total bilirubin ≤ 1.5 x the upper limit of normal (ULN)
* Alanine aminotransferase (ALT) and aspartate amino-transferase (AST) ≤ 2.5 x ULN (≤ 5 x ULN for subjects with liver involveme…
What they're measuring
1
Percent Reduction in CTCAE Grade 2/3 Eosinophil-related Cutaneous Adverse Events