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Tests treatment safety and results for Gastrointestinal Stromal Tumors
Official title The Efficacy and Safety of Temozolomide in SDH-deficient GIST
ClinicalTrials.gov ID: NCT05661643
What this study is testing
What is Temozolomide capsule?
Temozolomide capsule is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for gastrointestinal stromal tumors.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The goal of this clinical trial is to investigate the efficacy and safety of temozolomide in SDH deficiency GIST patients.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 20 and older
You may be able to join if
- 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
You likely can't join if
- 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...
- If any of the following applies within ≤ 6 months prior to starting study enrollment : Myocardial Infarction, severe instable angina...
- Uncontrolled infection
- Acute and chronic liver disease and all chronic liver impairment.(But Patients with stable chronic hepatitis B are eligible
See the full eligibility criteria
- 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
- Neutrophil \>1,500/mm3
- Platelet \> 100,000/mm3
- Hemoglobin \>8.0 g/dL
- Total bilirubin \< 1.5 x upper limit of normal (ULN)
- AST/ALT \< 2.5 x ULN
- Creatinine \<1.5 x ULN
- Life expectancy ≥12 weeks
- Disease progression or discontinuation of treatment due to intolerable toxicity at least with palliative 1st line imatinib .
- Washout period of previous TKIs or chemotherapy for more than 4 times the half life ((Imitinib and regorafenib need 1 week and sunitinib need 2 weeks.)
- Provision of a signed written informed consent
- 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...
- 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).
- History of another primary malignancy that is currently clinically significant or currently requires active intervention.
- Alcohol or substance abuse disorder
- The patients with NTRK fusion 5)
The study team makes the final eligibility decision.
Where it's taking place
- Seoul, Seoul, South Korea
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 20 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Seoul, Seoul, South Korea. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.