Trial Outcomes & Findings for Lenvatinib and Iodine Therapy in Treating Patients With Radioactive Iodine-Sensitive Differentiated Thyroid Cancer (NCT NCT03506048)

Last Updated: 2022-11-10

Results Overview

The time-to-progression (TTP) will be the primary endpoint for study, and will be determined using all enrolled patients in accordance with the intention to treat (ITT) principle. The study is formulated to have power = 0.90 at the significance level of 0.05 to correctly detect that improvement in median time to progression from 6 moths to 12 months.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

4 participants

Primary outcome timeframe

Up to 2 years from when a participant started at baseline

Results posted on

2022-11-10

Participant Flow

Participant milestones

Participant milestones
Measure	Treatment (Lenvatinib) Patients receive 24mg of lenvatinib by mouth (PO) everyday (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. Lenvatinib: Given orally once daily continuously
Overall Study STARTED	4
Overall Study COMPLETED	3
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Lenvatinib and Iodine Therapy in Treating Patients With Radioactive Iodine-Sensitive Differentiated Thyroid Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment (Lenvatinib) n=4 Participants 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. Lenvatinib: Given orally once daily continuously
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=5 Participants
Age, Categorical >=65 years	3 Participants n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	4 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	3 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	4 participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 2 years from when a participant started at baseline

Population: No data displayed because Outcome Measure has zero total participants analyzed.The study was closed for lack of feasibility due to lack of enrollment. Therefore there is no data to report.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 2 years from when a participant started at baseline

Objective response rate and disease control rate will be summarized. For the expansion cohorts, objective response rate will be presented along with 95% exact confidence intervals. 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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 2 years from when a participant started at baseline

Population: No data displayed because Outcome Measure has zero total participants analyzed.The study was closed for lack of feasibility due to lack of enrolment. Therefore there is no data to report.

Biochemical response will be assessed using suppressed and stimulated thyroglobulin. Thyroglobulin will be checked at baseline and post RAI every 3 months for 12 months and every 4-6 months thereafter as clinically indicated. Stimulated thyroglobulin obtained at baseline, prior to RAI, at 3 months, 6 months and 12 months post RAI will be used to define biochemical response. Unstimualte Tg levels may be used if unable to obtain stimulated Tg

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 2 years from when a participant started at baseline

Biochemical response will be assessed using suppressed and stimulated thyroglobulin antibody. Thyroglobulin antibody will be checked at baseline and post RAI every 3 months for 12 months and every 4-6 months thereafter as clinically indicated. Stimulated thyroglobulin obtained at baseline, prior to RAI, at 3 months, 6 months and 12 months post RAI will be used to define biochemical response. Unstimualte Tg levels may be used if unable to obtain stimulated Tg

Outcome measures

Outcome data not reported

Adverse Events

Treatment (Lenvatinib)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Taofeek Owonikoko

Emory University

Phone: 412-647-9975

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place