The Efficacy and Safety of Temozolomide in SDH-deficient GIST
ConditionGastrointestinal Stromal Tumors
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age20+
SponsorAsan Medical Center
About this trial
The goal of this clinical trial is to investigate the efficacy and safety of temozolomide in SDH deficiency GIST patients.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 20 years or older, at the time of acquisition of informed consent
Histologically confirmed GIST with CD117(+), DOG-1(+)
Wild type GIST without KIT or PDGFRα gene mutations determined by Sanger sequencing and panel sequencing
Eastern Cooperative Oncology Group (ECOG) performance status 0 ~ 2
Disqualifiers
Confirmed GIST with KIT or PDGFRα gene mutations determined by Sanger sequencing and panel sequencing
Women of child-bearing potential who are pregnant or breast feeding
Women or men who are not willing to use effective contraception entering the study period or until at least 6 months after the last study drug administration
If any of the following applies within ≤ 6 months prior to starting study enrollment : Myocardial Infarction, severe instable angina, coronary/peripheral bypass, NYHA class III or IV congestive heart failure, stroke or transient ischemic attack, treatment required severe arrhythmia
Trial design
Design model
Single group
Treatments tested in this trial
Temozolomide capsule
DrugTemozolomide 200 mg/m2 is administered orally for 1-5 days of each cycle, and then canceled for 23 days (a total of 28 days is 1 cycle)
Treatment groups
29 Participants
are divided into 1 treatment groupGroup A: temozolomide treatmentExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Objective respone rate in SDH deficiency wild type GIST
complet response+partial response defined by RECIST v1.1
Time frame
up to 4 yearsSponsors and contacts
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Source ClinicalTrials.gov