Lenvatinib After Progression on Imatinib, Sunitinib, and Regorafenib for GIST Patients

NCT07096609 | Not Yet Recruiting Phase 1

• 1 other identifier: AMC2502
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

GIST

Keywords

GIST; Lenvatinib

Outcome Measures

Primary Outcomes (1)

• DCR(disease control rate) at 12 weeks

  To evaluate the disease control rate (DCR; defined as the sum of partial responses and stable disease) at 12 Weeks

  at 12 weeks

Study Arms (1)

Lenvatinib treatment

EXPERIMENTAL

Drug: Lenvatinib Capsules

Interventions

Lenvatinib Capsules DRUG

Lenvatinib will be administered orally once daily at a dose of 12 mg (for patients weighing ≥ 60 kg) or 8 mg (for patients weighing \< 60 kg). Each treatment cycle consists of 4 weeks (i.e., 28 days).

Lenvatinib treatment

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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 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 mg/day on a continuous schedule; regorafenib 120 mg/day)
• 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 Grade 3-4 or persistent ≥ Grade 2 non-hematologic toxicity deemed intolerable
• 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.

You may not qualify 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 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 the past 12 months)
• 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 or IV, stroke or transient ischemic attack (TIA), or clinically significant arrhythmias requiring treatment
• 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, or interfere with the interpretation of study results, as determined by the investigator
• 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 to a maximum dose of 325 mg/day
• 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 during VEGF inhibitor therapy
• 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 not limited to hypertensive crisis, hypertensive encephalopathy, stroke, transient ischemic attack (TIA), or clinically significant peripheral vascular disease

Sponsors & Collaborators

• Asan Medical Center: lead

Study Sites (1)

Asan Medical Center

Seoul, 05505, South Korea

Location

MeSH Terms

Interventions

lenvatinib

Central Study Contacts

Jaewon Hyung

CONTACT

82-2-3010-1464; [email protected]

Hyung-Don kim

CONTACT

82-2-3010-0236; [email protected]

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: July 24, 2025
• First Posted: July 31, 2025
• Study Start: September 8, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: July 31, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)