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Study of the Efficacy of Lenvatinib Combined With Denosumab in the Treatment of Patients With Predominant Bone Metastatic Radioiodine Refractory Differentiated Thyroid Carcinomas

NCT03732495 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2022-03-29

No results posted yet for this study

Summary

This study evaluates the combination of lenvatinib with denosumab in bone-predominant metastatic Radioiodine Refractory Differentiated Thyroid Carcinomas. All patients will receive this combination of treatments.

Conditions

  • Thyroid Cancer Metastatic

Interventions

DRUG

Lenvatinib + Denosumab

Lenvatinib and Denosumab will be used in the indication of their respective SmPCs. Study treatments will be divided in fictitious cycles of 28 days. Lenvatinib and Denosumab will be administered as per investigator's decision, based on the data from their SmPC, at starting doses of 24mg once daily and 120mg once every 4 weeks, respectively. Dose modification guidelines of their respective SmPCs will apply. Lenvatinib should be started the day after the inclusion. It will be taken every day at the same time, preferentially in the morning. As in routine practice, all patients will be supplemented with daily doses of at least 500mg Calcium and 400IU Vitamin D, unless hypercalcemia is present. Patients will be encouraged to maintain good oral hygiene during treatment with Denosumab. Study drugs will be continued until a treatment discontinuation criterion is met

Sponsors & Collaborators

  • Centre Leon Berard

    lead OTHER

Principal Investigators

  • Christelle De La Fouchardiere, MD · Centre Leon Berard

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-07-26
Primary Completion
2022-12-15
Completion
2023-01-15

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03732495 on ClinicalTrials.gov