Management of Imatinib-associated Severe Skin Rash in Patients With Gastrointestinal Stromal Tumor

Phase 2

Completed

• Conditions: Gastrointestinal Stromal Tumor(GIST)
• Interventions: Drug: Prednisone

• Registration Number: NCT03440515
• Lead Sponsor: Asan Medical Center

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-08
• Primary Completion: 2017-06
• Study Completion: 2017-06
• Study First Submitted: 2018-02-09
• Study First Submitted QC: 2018-02-19
• Study First Posted: 2018-02-22
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-06
• Last Update Posted: 2020-01-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 29

Inclusion Criteria

• Age 18 years or older, at the time of acquisition of informed consent
• Histologically confirmed metastatic and/or advanced (unresectable or recurrent) GIST with CD117(+), DOG-1(+), or mutation in KIT or PDGFRα gene
• Patients with metastatic and/or advanced (unresectable or recurrent) GISTs, receiving imatinib as adjuvant or neo adjuvant, palliative chemotherapy for pre-or post- operations
• imatinib-associated severe skin rash which was defined as grade 3 skin rash or grade 2 skin rash with pruritus over grade 2

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
prednisone	Prednisone	prednisone 30mg/day 3weeks oral, if on rash or pruritus prednisolone 20mg/day 3weeks -\> 10mg/day-\>7.5mg/day-\>5mg/day-\>stop

Primary Outcome Measures

Name	Time	Method
treatment success rate	2 years	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.