Back to resultsManagement of Imatinib-associated Severe Skin Rash in Patients With Gastrointestinal Stromal Tumor
Primary Purpose
Gastrointestinal Stromal Tumor(GIST)
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Prednisone
Sponsored by
About this trial
This is an interventional treatment trial for Gastrointestinal Stromal Tumor(GIST) focused on measuring gastrointestinal stromal tumor, skin rash, imatinib
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
prednisone
Arm Description
prednisone 30mg/day 3weeks oral, if on rash or pruritus prednisolone 20mg/day 3weeks -> 10mg/day->7.5mg/day->5mg/day->stop
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03440515
Brief Title
Management of Imatinib-associated Severe Skin Rash in Patients With Gastrointestinal Stromal Tumor
Official Title
Management of Imatinib-associated Severe Skin Rash in Patients With Gastrointestinal Stromal Tumor
Study Type
Interventional
2. Study Status
Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
August 2014 (Actual)
Primary Completion Date
June 2017 (Actual)
Study Completion Date
June 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Asan Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastrointestinal Stromal Tumor(GIST)
Keywords
gastrointestinal stromal tumor, skin rash, imatinib
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
29 (Actual)
8. Arms, Groups, and Interventions
Arm Title
prednisone
Arm Type
Experimental
Arm Description
prednisone 30mg/day 3weeks oral, if on rash or pruritus prednisolone 20mg/day 3weeks -> 10mg/day->7.5mg/day->5mg/day->stop
Intervention Type
Drug
Intervention Name(s)
Prednisone
Intervention Description
Prednisone treatment for severe skin rash induced by imatinib
Primary Outcome Measure Information:
Title
treatment success rate
Description
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.
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yoon-Koo Kang, MD, PhD
Organizational Affiliation
Asan Medical Center
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
32589310
Citation
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.
Results Reference
derived
Learn more about this trial
Management of Imatinib-associated Severe Skin Rash in Patients With Gastrointestinal Stromal Tumor
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