RecruitingPhase 2

The Efficacy and Safety of Temozolomide in SDH-deficient GIST

South Korea29 participantsStarted 2023-06-28

Plain-language summary

The goal of this clinical trial is to investigate the efficacy and safety of temozolomide in SDH deficiency GIST patients.

Age range20 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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
✓. Resolution of all adverse events with prior treatments to grade 0 or 1 by NCI-CTCAE version 5.0
✓. At least one measurable lesion by RECIST version 1.1.
✓. Adequate bone marrow, hepatic, renal, and other organ functions, before adjuvant imatinib treatment
✓. Life expectancy ≥12 weeks

✕. 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
✕. Uncontrolled infection
✕. Acute and chronic liver disease and all chronic liver impairment.(But Patients with stable chronic hepatitis B are eligible
✕. Acute, or chronic medical or psychiatric condition or laboratory abnormality such as active uncontrolled infection that difficult to study participation in the judgment of the investigator
✕. Known diagnosis of HIV infection (HIV testing is not mandatory).

Objective respone rate in SDH deficiency wild type GIST

Timeframe: up to 4 years

NCT IDNCT05661643

SponsorAsan Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-12-01

Min-Hee Ryu, MD, PhD

Who can participate

Age range20 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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
✓. Resolution of all adverse events with prior treatments to grade 0 or 1 by NCI-CTCAE version 5.0
✓. At least one measurable lesion by RECIST version 1.1.
✓. Adequate bone marrow, hepatic, renal, and other organ functions, before adjuvant imatinib treatment
✓. Life expectancy ≥12 weeks

✕. 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
✕. Uncontrolled infection
✕. Acute and chronic liver disease and all chronic liver impairment.(But Patients with stable chronic hepatitis B are eligible
✕. Acute, or chronic medical or psychiatric condition or laboratory abnormality such as active uncontrolled infection that difficult to study participation in the judgment of the investigator
✕. Known diagnosis of HIV infection (HIV testing is not mandatory).