NCT03440515|CompletedPhase 2
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Sponsor study identifier
interventional
29
0 countries
N/A
Study Start
August 2014
Actual (reported)Primary Completion
June 2017
Actual (reported)Study Completion
June 2017
Actual (reported)To achieve optimal clinical outcomes with imatinib in GIST patients, it is crucial to maintain standard imatinib dose. Skin rash is a relatively common and sometimes severe adverse event of imatinib in GIST patients and may affect imatinib compliance. Our previous retrospective study suggested that severe skin rash induced by imatinib can be managed by systemic steroid without imatinib dose interruption or reduction. This phase II study was conducted to evaluate the efficacy and safety of systemic steroid in GIST patients with imatinib-associated severe skin rash.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 2017
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 2014
Actual (reported)June 2017
Actual (reported)June 2017
Actual (reported)February 9, 2018
Actual (reported)February 22, 2018
Actual (reported)treatment success rate
Treatment success was defined as maintaining imatinib without persistence or recurrence of skin rash requiring 1) additional systemic steroid treatment, and 2) interruption or dose reduction of imatinib.
2 years
prednisone 30mg/day 3weeks oral, if on rash or pruritus prednisolone 20mg/day 3weeks -\> 10mg/day-\>7.5mg/day-\>5mg/day-\>stop
Prednisone treatment for severe skin rash induced by imatinib
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Kim EJ, Ryu MH, Park SR, Beck MY, Lee WJ, Lee MW, Kang YK. Systemic Steroid Treatment for Imatinib-Associated Severe Skin Rash in Patients with Gastrointestinal Stromal Tumor: A Phase II Study. Oncologist. 2020 Nov;25(11):e1785-e1793. doi: 10.1634/theoncologist.2019-0953. Epub 2020 Jul 12.
Yoon-Koo Kang, MD, PhD
Asan Medical Center
29 participants (actual enrollment reported by the registry).
First Submitted
February 9, 2018
First Posted
February 22, 2018
Study Start
August 2014
Actual (reported)Delayed Release Prednisone in PMR
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Primary Completion
June 2017
Actual (reported)Study Completion
June 2017
Actual (reported)Last Updated
January 7, 2020
Record last verified: 2020-01
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Source: ClinicalTrials.gov.
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