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

NCT03440515 | Completed Phase 2

• 1 other identifier: AMC1402
• Study Type: interventional
• Target: 29
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Gastrointestinal Stromal Tumor(GIST)

Keywords

gastrointestinal stromal tumor; skin rash; imatinib

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

prednisone

EXPERIMENTAL

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

Drug: Prednisone

Interventions

Prednisone DRUG

Prednisone treatment for severe skin rash induced by imatinib

prednisone

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• Asan Medical Center: lead

Related Publications (1)

• 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.

  PMID: 32589310 DERIVED

MeSH Terms

Conditions

Gastrointestinal Stromal Tumors; Exanthema

Interventions

Prednisone

Condition Hierarchy (Ancestors)

Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Yoon-Koo Kang, MD, PhD

  Asan Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 9, 2018
• First Posted: February 22, 2018
• Study Start: August 1, 2014
• Primary Completion: June 1, 2017
• Study Completion: June 1, 2017
• Last Updated: January 7, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share