Parathyroid CarcinomaPhase 2ALPSNCT07843901
Lenvatinib in Patients With Advanced Parathyroid Carcinoma
A Phase 2 study testing Lenvatinib in people with Parathyroid Carcinoma, run by Yonsei University.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Parathyroid Carcinoma
- What is being tested?
- Lenvatinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- No sites listed yet
- Study dates
- Nov 2026to Aug 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants must meet all of the following inclusion criteria prior to enrollment in the clinical trial:
- Parathyroid carcinoma confirmed by histopathological or cytological examination.
- Unresectable advanced or metastatic disease:
- 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.
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- Curative surgical resection considered inappropriate by the investigator due to the participant's general condition, comorbidities, or other clinical considerations.
- At least one measurable lesion according to RECIST version 1.1.
- Age ≥19 years at the time of informed consent.
- ECOG performance status of 0 or 1.
- Adequate organ and bone marrow function, as demonstrated by all of the following screening laboratory criteria:
- Absolute neutrophil count (ANC) ≥1,500/mm³.
- Platelet count ≥100,000/mm³.
- Hemoglobin ≥9 g/dL.
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤3 × the upper limit of normal (ULN); ≤5 × ULN in participants with liver metastases.
- Total bilirubin ≤1.5 × ULN; ≤3 mg/dL is permitted in participants with Gilbert syndrome.
- Serum creatinine ≤2.5 × ULN or estimated glomerular filtration rate (eGFR) ≥30 mL/min/1.73 m², calculated using the CKD-EPI equation.
- Urine protein-to-creatinine ratio (UPCR) ≤1 mg/mg or 24-hour urine protein <1 g.
- Participants who understand the purpose and procedures of the clinical trial and voluntarily provide written informed consent.
- Sexually active participants of childbearing potential and their partners who agree to use adequate contraception (e.g., male or female condoms).
- Female participants of childbearing potential must have a negative pregnancy test at screening. Women who have had menstruation within the preceding 12 months will be considered to be of childbearing potential. Amenorrhea due to anticancer treatment, hormonal suppression, low body weight, or other causes may also be considered consistent with childbearing potential.
Who cannot join
- Participants meeting any of the following criteria will be excluded from participation in the study:
- 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.
- Uncontrolled or clinically significant comorbidities, including any of the following:
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- Clinically significant cardiovascular disease occurring within 6 months before initiation of study treatment:
- Symptomatic congestive heart failure, unstable angina, or severe arrhythmia.
- Uncontrolled hypertension despite appropriate treatment, defined as systolic blood pressure >150 mmHg or diastolic blood pressure >100 mmHg.
- Clinically significant and unresolved stroke, myocardial infarction, other ischemic events, or thromboembolic events (e.g., deep vein thrombosis or pulmonary embolism) occurring within 3 months before initiation of study treatment.
- Gastrointestinal disease or conditions associated with an increased risk of gastrointestinal perforation or fistula:
- Gastrointestinal tumor invasion, active peptic ulcer disease, inflammatory bowel disease, diverticulitis, cholecystitis, symptomatic cholangitis or appendicitis, or acute pancreatitis.
- Pancreatic or biliary duct obstruction, or gastric outlet obstruction.
- Intra-abdominal fistula, gastrointestinal perforation, intestinal obstruction, or intra-abdominal abscess occurring within 6 months before initiation of study treatment. Participants with completely resolved conditions may be eligible.
- Gross hematuria, hematemesis, or hemoptysis of ≥0.5 teaspoon (approximately 2.5 mL) within 3 months before initiation of study treatment, or a history of other significant bleeding (e.g., pulmonary hemorrhage).
- Radiographic evidence of cavitary pulmonary lesions or endobronchial lesions.
- Lesions involving major pulmonary blood vessels.
- Other clinically significant medical conditions, including:
- Active infection requiring systemic treatment, HIV infection, or AIDS-related illness. Participants with hepatitis B virus (HBV) infection that is stable during or after antiviral treatment, or participants with hepatitis C virus (HCV) infection may be eligible.
- Clinically significant unhealed wounds, ulcers, or fractures.
- Malabsorption syndrome.
- Moderate or severe hepatic impairment corresponding to Child-Pugh class B or C.
- History of organ transplantation.
- Major surgery (e.g., gastrointestinal surgery) within 28 days before initiation of study treatment, or unresolved complications from previous surgery.
- Corrected QT interval using the Fridericia formula (QTcF) >500 msec.
- Women who are pregnant or breastfeeding.
- Inability to take oral medications in tablet or capsule form.
- History of allergy or hypersensitivity to any component of the study drug.
- Diagnosis of another malignancy within 3 years before initiation of study treatment. Exceptions include non-melanoma skin cancer, completely resected stage I breast cancer, completely resected carcinoma in situ or non-muscle-invasive bladder cancer, cervical and/or uterine carcinoma, or T1a squamous cell carcinoma of the esophagus.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Phase II Study of Lenvatinib in Patients With Advanced Parathyroid Carcinoma(ALPS)
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.
Read more
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.
- Conditions
- Parathyroid Carcinoma
- Being tested
- Lenvatinib
- Medical subject headings
- Parathyroid Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LenvatinibDrug
This 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.
| Study group | Role | What they receive |
|---|---|---|
| Lenvatinib monotherapy. | Experimental | Advanced or metastatic parathyroid cancer patients will receive lenvatinib monotherapy. Receives: Drug: Lenvatinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: End of trial(approximately 3 years)
Secondary outcomes (5)
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.
Measured: End of trial(approximately 3 years)
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.
Measured: End of trial(approximately 3 years)
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.
Measured: End of trial(approximately 3 years)
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.
Measured: End of trial(approximately 3 years)
Treatment-Emergent Adverse Events
Treatment-emergent adverse events will be assessed in all participants who receive at least one dose of lenvatinib. Adverse events will be graded according to CTCAE version 5.0 and summarized by incidence, severity, and type.
Measured: End of trial(approximately 3 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2026
- Study startNov 2026 (estimated)
- Primary completionAug 2028 (estimated)
- Study completionAug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parathyroid CarcinomaStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is a single-arm, open-label, interventional clinical trial evaluating the efficacy and safety of lenvatinib monotherapy in patients with advanced or metastatic parathyroid carcinoma. Lenvatinib will be administered orally at a dose of 24 mg once daily in 3-week cycles until disease progression or unacceptable toxicity.
- Masking
- None (open label)
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chang Gon Kim, Yonsei University
- Investigators
- CHANG Gon KIM, Principal investigator, Yonsei University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07843901
- Sponsor's protocol ID
- 4-2026-1025
- Acronym
- ALPS
- Status last verified
- Sep 2026
- First submitted
- 10 Sep 2026
- Last updated
- 28 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Lenvatinib in Patients With Advanced Parathyroid Carcinoma(ALPS)
- ClinicalTrials.gov ID
- NCT07843901
- Acronym / sponsor ID
- ALPS / 4-2026-1025
- Conditions
- Parathyroid Carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- Nov 2026 (estimated)
- Primary completion
- Aug 2028 (estimated)
- Study completion
- Aug 2029 (estimated)
- First posted
- 28 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a single-arm, open-label, interventional clinical trial evaluating the efficacy and safety of lenvatinib monotherapy in patients with advanced or metastatic parathyroid carcinoma. Lenvatinib will be administered orally at a dose of 24 mg once daily in 3-week cycles until disease progression or unacceptable toxicity.
| Arm | Type | Receives |
|---|---|---|
| Lenvatinib monotherapy. | Experimental | Drug: LenvatinibAdvanced or metastatic parathyroid cancer patients will receive lenvatinib monotherapy. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- Participants must meet all of the following inclusion criteria prior to enrollment in the clinical trial:
- Parathyroid carcinoma confirmed by histopathological or cytological examination.
- Unresectable advanced or metastatic disease:
- At least one measurable lesion according to RECIST version 1.1.
- Age ≥19 years at the time of informed consent.
Key exclusion criteria (29 listed)
- Participants meeting any of the following criteria will be excluded from participation in the study:
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LenvatinibThis 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. | Drug | Lenvatinib monotherapy. |
Primary outcome
Objective Response Rate (ORR)
Time frame: End of trial(approximately 3 years)
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.
5 secondary outcomes
Progression-Free Survival (PFS)
Time frame: End of trial(approximately 3 years)
Overall Survival (OS)
Time frame: End of trial(approximately 3 years)
Duration of Response (DoR)
Time frame: End of trial(approximately 3 years)
Disease Control Rate (DCR)
Time frame: End of trial(approximately 3 years)
Treatment-Emergent Adverse Events
Time frame: End of trial(approximately 3 years)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
CHANG Gon KIM principal investigator
Yonsei University
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Lenvatinib in people with Parathyroid Carcinoma, run by Yonsei University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 21 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 28 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chang Gon Kim (82-10-9162-1729, inspector@yuhs.ac), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate (ORR) (time frame: End of trial(approximately 3 years)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2026.