Lenvatinib After Progression on Imatinib, Sunitinib, and Regorafenib for GIST Patients
ConditionGIST
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age20+
SponsorAsan Medical Center
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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)
Trial design
Design model
Single group
Treatments tested in this trial
Lenvatinib Capsules
DrugLenvatinib 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).
Treatment groups
48 Participants
are divided into 1 treatment groupGroup A: Lenvatinib treatmentExperimental treatment 1 intervention
Trial outcomes
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
Time frame
at 12 weeksSponsors and contacts
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Source ClinicalTrials.gov