Lenvatinib and Iodine Therapy in Treating Patients With Radioactive Iodine-Sensitive Differentiated Thyroid Cancer
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|ClinicalTrials.gov Identifier: NCT03506048|
Recruitment Status : Recruiting
First Posted : April 23, 2018
Last Update Posted : January 23, 2019
|Condition or disease||Intervention/treatment||Phase|
|Differentiated Thyroid Gland Carcinoma Thyroid Gland Follicular Carcinoma Thyroid Gland Papillary Carcinoma||Drug: Lenvatinib||Phase 2|
I. To evaluate the efficacy of lenvatinib pretreatment along with radioactive iodine (RAI) in patients with previously treated RAI sensitive thyroid cancer.
I. To demonstrate the safety of the combination of lenvatinib and RAI in patients with Iodine sensitive differentiated thyroid carcinoma (DTC).
II. To assess dynamic changes in established serum based biomarkers of DTC (thyroglobulin [Tg] and Tg antibody).
III. To explore the utility of protein and genetic biomarkers to predict treatment efficacy.
Patients receive lenvatinib orally (PO) once daily (QD) for 8 weeks and up to 12 weeks in the absence of disease progression or unaccepted toxicity. Patients also receive iodine I-131 PO daily as standard of care.
After completion of study treatment, patients are followed up within 6 weeks, every 3 months for 1 year, and then periodically thereafter.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 2 Study of Lenvatinib in Combination With Radioactive Iodine Therapy in Patients With Progressive RAI-Sensitive Differentiated Thyroid Cancer|
|Actual Study Start Date :||January 16, 2019|
|Estimated Primary Completion Date :||January 31, 2021|
|Estimated Study Completion Date :||January 31, 2021|
Experimental: Treatment (lenvatinib)
Patients receive lenvatinib PO QD for 8 weeks and up to 12 weeks in the absence of disease progression or unaccepted toxicity. Patients also receive radioactive iodine (RAI) I-131 orally as standard of care.
Given orally once daily continuously
- Time-to-progression [ Time Frame: Up to 2 years after study start ]The censored time-to-treatment failure will be estimated with standard Kaplan-Meier methodology. Both point and 90% confidence interval estimates of the median and other statistics (e.g., 3-month rate, 6-month rate, etc.) from the censored time-to-treatment failure distribution will be calculated.
- Best objective response [ Time Frame: Up to 2 years after study start ]Patients will be assigned one of the following categories: complete response (CR), partial response (PR), stable disease (SD), progressive disease, non-evaluable, and disease control (CR + PR + SD). The same method of assessment and the same technique will be used to characterize each identified and reported lesion at baseline and during follow-up.
- Change in thyroglobulin levels [ Time Frame: Baseline up to 2 years ]Will assess dynamic changes in thryoglobulin levels. Levels at baseline will be a reference point.
- Change in thyroglobulin antibody levels [ Time Frame: Baseline up to 2 years ]Will assess dynamic changes in thryoglobulin antibody levels. Levels at baseline will be a reference point.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03506048
|Contact: Taofeek K. Owonikoko, MD, PhDfirstname.lastname@example.org|
|United States, Georgia|
|Emory University Hospital/Winship Cancer Institute||Recruiting|
|Atlanta, Georgia, United States, 30322|
|Contact: Shantina Walls 404-778-4995 email@example.com|
|Principal Investigator:||Taofeek K. Owonikoko, MD, PhD||Emory University|