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New treatment option for GIST
Official title Lenvatinib After Progression on Imatinib, Sunitinib, and Regorafenib for GIST Patients
ClinicalTrials.gov ID: NCT07096609
What this study is testing
What is Lenvatinib Capsules?
Lenvatinib Capsules is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for gist.
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 aim of this study is to evaluate the safety and efficacy of lenvatinib in patients with metastatic or advanced GIST who have failed at least imatinib, sunitinib, and regorafenib treatment.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
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 at the time of providing written informed consent.
- Histologically confirmed metastatic and/or advanced (unresectable or recurrent) GIST with positivity for CD117(+), DOG-1(+), or harboring mutations...
- Documented failure of prior treatment with imatinib, sunitinib, and regorafenib due to disease progression and/or intolerance.
- Note: There is no limitation on the number of prior therapies. Prior use of other tyrosine kinase inhibitors (TKIs) or chemotherapy in combination...
- Disease progression is defined as:
You likely can't join if
- Women of childbearing potential who are pregnant or breastfeeding
- Women or men unwilling to use effective contraception during the study treatment period and for 6 months after the last dose of the investigational...
- All participants (both men and women) must use barrier contraception during the treatment period and for at least 1 month after the final dose
- Women of childbearing potential are defined as sexually mature females who have not undergone hysterectomy or who have not been naturally...
- History of any of the following within 6 months prior to enrollment: myocardial infarction, severe or unstable angina, coronary or peripheral artery...
- Uncontrolled active infection
See the full eligibility criteria
Who can join
- Age ≥ 20 years at the time of providing written informed consent.
- Histologically confirmed metastatic and/or advanced (unresectable or recurrent) GIST with positivity for CD117(+), DOG-1(+), or harboring mutations in the KIT or PDGFRα genes.
- Documented failure of prior treatment with imatinib, sunitinib, and regorafenib due to disease progression and/or intolerance.
- Note: There is no limitation on the number of prior therapies. Prior use of other tyrosine kinase inhibitors (TKIs) or chemotherapy in combination with imatinib, sunitinib, or regorafenib is permitted.
- Disease progression is defined as:
- Increase in tumor size by ≥ 20% per mRECIST version 1.1
- Emergence of unequivocal new lesions (excluding newly developed small cystic liver lesions within 6 months after initiation of TKI treatment)
- Appearance of new solid nodules within cystic masses
- Increase in the size of existing solid nodules within cystic masses (\>20%)
- Intolerance to prior TKIs is defined as:
- Drug compliance \<75% due to ≥ Grade 2 non-hematologic toxicity, despite dose reduction to one level below the standard dose (i.e., imatinib 300 mg/day; sunitinib 37.5 mg/day on a 4-week on/2-week off schedule or 25...
- Despite the same dose reduction as above, the occurrence of febrile neutropenia, Grade 4 neutropenia lasting more than 6 days, Grade 4 thrombocytopenia, Grade 3 thrombocytopenia with clinically significant bleeding, or...
- ECOG performance status of 0-2.
- All toxicities from previous treatments must have recovered to Grade 0 or 1 as per NCI-CTCAE version 5.0.
- At least one measurable lesion as defined by mRECIST version 1.1.
- Adequate bone marrow, liver, renal, and other organ function:
- Absolute neutrophil count (ANC) ≥ 1,500/mm³
- Platelets ≥ 100,000/mm³
- Hemoglobin ≥ 8.0 g/dL
- Total bilirubin ≤ 1.5 × upper limit of normal (ULN)
- AST/ALT ≤ 2.5 × ULN (or ≤ 5 × ULN in case of liver metastases)
- Serum creatinine ≤ 1.5 × ULN
- Life expectancy ≥ 12 weeks
- A washout period equivalent to at least 4 times the half-life of previous TKI or chemotherapeutic agents is required(Imatinib and regorafenib: ≥ 1 week; Sunitinib: ≥ 2 weeks)
- Signed written informed consent
What rules you out
- Women of childbearing potential who are pregnant or breastfeeding
- Women or men unwilling to use effective contraception during the study treatment period and for 6 months after the last dose of the investigational drug
- All participants (both men and women) must use barrier contraception during the treatment period and for at least 1 month after the final dose
- Women of childbearing potential are defined as sexually mature females who have not undergone hysterectomy or who have not been naturally postmenopausal for at least 12 consecutive months (i.e., had menstruation within...
- History of any of the following within 6 months prior to enrollment: myocardial infarction, severe or unstable angina, coronary or peripheral artery bypass surgery, congestive heart failure classified as NYHA Class III...
- Uncontrolled active infection
- Diabetes mellitus with clinically significant signs of peripheral vascular disease
- Acute or chronic liver disease, or any chronic hepatic disorder (patients with stable chronic hepatitis B are eligible)
- Uncontrolled gastrointestinal toxicities greater than Grade 2 according to NCI-CTCAE (e.g., nausea, diarrhea, vomiting)
- Any severe acute or chronic medical or psychiatric condition, or clinically significant abnormal laboratory finding, that may increase the risk associated with study participation or investigational drug administration...
- History of life-threatening bleeding or any Grade 3 or 4 bleeding event requiring transfusion, endoscopic intervention, or surgical procedure within 3 months prior to initiation of study drug
- Treatment with clinically significant systemic anticoagulant or antithrombotic agents within 7 days prior to consent that, in the opinion of the investigator, may put the patient at risk. Use of aspirin is permitted up...
- Uncontrolled hypertension (blood pressure ≥ 140/90 mmHg) that is not adequately managed with medication, or change in antihypertensive regimen within 7 days prior to consent; such patients may be at increased risk...
- Major surgery, significant trauma (e.g., bone fracture), or non-healed wounds within 3 weeks prior to consent (procedures such as catheter insertion are not considered major)
- History of other significant cardiovascular or vascular conditions within 6 months prior to consent that, in the opinion of the investigator, may place the patient at risk during VEGF inhibitor therapy, including but...
- Clinically significant glomerulonephritis, biopsy-proven tubulointerstitial nephritis, crystal nephropathy, or other history of renal failure
- Known diagnosis of HIV infection (HIV testing is not mandatory)
- History of another primary malignancy that has recently become clinically significant or currently requires active intervention
- Evidence of brain metastasis on radiological imaging (e.g., CT or MRI) in patients presenting with symptoms suggestive of central nervous system involvement
- History of alcohol or substance abuse disorder
The study team makes the final eligibility decision.
Where it's taking place
- 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, 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.