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
Qualifiers
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
Treatments tested in this trial
- Lenvatinib Capsules
Treatment groups
48 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov