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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

29 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-08-31

Study Completion Date

2017-06-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Gastrointestinal Stromal Tumor(GIST)

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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prednisone

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

Group Type EXPERIMENTAL

Prednisone

Intervention Type DRUG

Prednisone treatment for severe skin rash induced by imatinib

Interventions

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Prednisone

Prednisone treatment for severe skin rash induced by imatinib

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No