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

A

Asan Medical Center

Status and phase

Completed
Phase 2

Conditions

Gastrointestinal Stromal Tumor(GIST)

Treatments

Drug: Prednisone

Study type

Interventional

Funder types

Other

Identifiers

NCT03440515
AMC1402

Details and patient eligibility

About

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.

Enrollment

29 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

29 participants in 1 patient group

prednisone
Experimental group
Description:
prednisone 30mg/day 3weeks oral, if on rash or pruritus prednisolone 20mg/day 3weeks -> 10mg/day->7.5mg/day->5mg/day->stop
Treatment:
Drug: Prednisone

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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