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

Gastrointestinal Stromal Tumor(GIST) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03440515
• Other study ID #: AMC1402
• Status: Completed
• Phase: Phase 2
• Start date: August 2014
• Est. completion date: June 2017

Study information

• Verified date: January 2020
• Source: Asan Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: June 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 PDGFRa 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

Related Conditions & MeSH terms

• Exanthema
• Gastrointestinal Stromal Tumor(GIST)
• Gastrointestinal Stromal Tumors

Intervention

Drug:
• Prednisone
Prednisone treatment for severe skin rash induced by imatinib

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Asan Medical Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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