Lenvatinib in Patients With Advanced Parathyroid Carcinoma
ConditionParathyroid Carcinoma
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age20+
SponsorYonsei University
About this trial
This is a multicenter, open-label, single-arm, phase II study evaluating the efficacy and safety of lenvatinib in patients with unresectable, advanced or metastatic parathyroid carcinoma.
Parathyroid carcinoma is a rare malignant tumor with limited systemic treatment options in patients with unresectable, recurrent, or metastatic disease. Excessive secretion of parathyroid hormone (PTH) and resulting hypercalcemia may cause significant morbidity and adversely affect prognosis and quality of life. Although complete surgical resection is considered the only potentially curative treatment for localized disease, no established standard systemic therapy is currently available for advanced or metastatic parathyroid carcinoma.
Lenvatinib is an oral multikinase inhibitor that targets vascular endothelial growth factor receptors (VEGFR1-3), fibroblast growth factor receptors (FGFR1-4), platelet-derived growth factor receptor alpha (PDGFRα), RET, and KIT. Inhibition of these signaling pathways may suppress tumor angiogenesis and tumor cell proliferation. Based on the potential role of angiogenic signaling in parathyroid carcinoma and the antitumor activity of lenvatinib demonstrated in various solid tumors, lenvatinib is being investigated as a potential treatment option for advanced or metastatic parathyroid carcinoma.
A total of 18 participants will be enrolled, including consideration of potential evaluability and dropout. Eligible participants must have histologically or cytologically confirmed parathyroid carcinoma that is unresectable, advanced, or metastatic, with at least one measurable lesion according to RECIST version 1.1. Participants must be at least 19 years of age and have an ECOG performance status of 0 or 1 with adequate bone marrow, renal, and hepatic function.
Lenvatinib will be administered orally once daily at a starting dose of 24 mg. Treatment will continue until disease progression, unacceptable toxicity, withdrawal of consent, or another protocol-defined reason for treatment discontinuation. Dose interruption or reduction to 20 mg, 14 mg, and 10 mg once daily may be implemented for treatment-related toxicities according to the protocol and applicable local prescribing information.
The primary objective is to evaluate the objective response rate (ORR), defined as the proportion of participants achieving a complete response (CR) or partial response (PR) according to RECIST version 1.1. Secondary objectives include evaluation of progression-free survival (PFS), overall survival (OS), disease control rate (DCR), and the safety and tolerability of lenvatinib. Exploratory objectives include assessment of changes in corrected serum calcium and PTH levels and exploration of associations between biochemical changes and clinical outcomes such as ORR and PFS.
Tumor response will be assessed according to RECIST version 1.1. Baseline imaging will be performed within 28 days before the first dose of study treatment. Tumor assessments will be performed every 8 weeks (±7 days) through Week 48 and every 12 weeks (±14 days) thereafter. Safety assessments will include adverse events, clinical laboratory tests, vital signs, physical examinations, ECOG performance status, and electrocardiograms.
The overall study period is planned for 3 years, with participant enrollment from July 1, 2026, through June 30, 2028. Each participant will be followed for up to 12 months after treatment discontinuation, or until study completion, as applicable.
The study is designed to evaluate whether lenvatinib provides clinically meaningful antitumor activity and an acceptable safety profile in patients with advanced or metastatic parathyroid carcinoma, while also exploring potential changes in calcium and PTH levels as disease-related biochemical outcomes.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Parathyroid carcinoma confirmed by histopathological or cytological examination.
Primary or locally recurrent lesions that extensively involve major blood vessels, the airway, or other critical organs, making curative surgical resection infeasible.
Presence of multiple distant metastases (e.g., lung, liver, or bone) that preclude curative surgical resection.
Additional curative surgical resection considered difficult due to repeated disease recurrence.
Disqualifiers
Prior treatment with lenvatinib for advanced or metastatic parathyroid carcinoma.
Treatment with another investigational medicinal product within 14 days before the first administration of the study drug.
Radiation therapy for bone metastases within 7 days before initiation of study treatment, or other external beam radiation therapy within 14 days before initiation of study treatment.
Active brain metastases. However, untreated asymptomatic and stable brain metastases, or brain metastases that have been adequately treated with radiation therapy or surgery (e.g., radiosurgery), are permitted if the brain metastases have remained stable for at least 14 days before initiation of study treatment and no neurological symptoms are present at enrollment.
Trial design
Design model
Single group
Treatments tested in this trial
Lenvatinib
DrugThis clinical trial evaluates the efficacy and safety of lenvatinib monotherapy in patients with advanced or metastatic parathyroid cancer. Lenvatinib will be administered orally at a dose of 24 mg once daily, with each cycle consisting of 3 weeks, and treatment will continue until disease progression or unacceptable toxicity. In the event of adverse events, treatment may be temporarily interrupted or the dose may be reduced according to the investigator's judgment and the study protocol.
Treatment groups
18 Participants
are divided into 1 treatment groupGroup A: Lenvatinib monotherapy.Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Objective Response Rate (ORR)
Objective Response Rate (ORR) is defined as the percentage of participants who achieve a confirmed Complete Response (CR) or Partial Response (PR) at least once according to RECIST version 1.1 before evidence of disease progression. ORR will be summarized in the efficacy-evaluable population and presented with a two-sided 95% confidence interval.
Time frame
End of trial(approximately 3 years)Secondary outcomes
1
Progression-Free Survival (PFS)
Progression-Free Survival (PFS) is defined as the time from the date of the first administration of the investigational medicinal product to the date of disease progression or death from any cause, whichever occurs first. PFS will be analyzed in the efficacy-evaluable population.
Time frame
End of trial(approximately 3 years)2
Overall Survival (OS)
Overall Survival (OS) is defined as the time from the date of the first administration of the investigational medicinal product to the date of death from any cause. OS will be analyzed in the safety analysis population and presented using Kaplan-Meier curves. The number and percentage of participants who died, remained alive, were lost to follow-up, or withdrew consent will be appropriately summarized.
Time frame
End of trial(approximately 3 years)3
Duration of Response (DoR)
Duration of Response (DoR) is defined as the time from the date of the first documented confirmed response to the date of disease progression or death, whichever occurs first. The start of response is defined as the date of the most recent visit at which PR or CR was confirmed. For participants who achieve a response and do not subsequently experience disease progression, the date of PFS censoring will be used to calculate the duration of response. DoR will be analyzed in the subset of the efficacy-evaluable population whose best overall response is a confirmed CR or PR. Kaplan-Meier curves and the median duration of response estimated using the Kaplan-Meier method will be presented.
Time frame
End of trial(approximately 3 years)4
Disease Control Rate (DCR)
Disease Control Rate (DCR) is defined as the percentage of participants whose best overall response (BOR), assessed according to RECIST version 1.1, is Complete Response (CR), Partial Response (PR), or Stable Disease (SD). DCR will be summarized in the efficacy-evaluable population and presented with a two-sided 95% confidence interval.
Time frame
End of trial(approximately 3 years)Locations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: