The purpose of this study is to evaluate the safety of lenvatinib in participants with recurrent, metastatic radio-iodine refractory differentiated thyroid cancer (DTC).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
50
Lenvatinib capsules.
Shetty's Hospital
Bangalore, Karnataka, India
Regional Cancer Centre, RCC, Thiruvananthapuram
Thiruvananthapuram, Kerala, India
Deenanath Mangeshkar Hospital
Pune, Maharashtra, India
Percentage of Participants with Grade 2 or Higher Treatment-emergent Adverse Events
TEAEs are defined as undesirable events not present prior to medical treatment, or an already present event that worsens either in intensity or frequency following the treatment. Adverse events (AEs) will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 where grade 2: Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental activity of daily living (ADL), grade 3: Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care ADL, grade 4: Life-threatening consequences; urgent intervention indicated and grade 5: Death related to AE.
Time frame: Baseline up to Week 24
Number of Dose Reductions
The number of instances of participants having to reduce the dosage of study drug based on specified toxicities.
Time frame: Baseline up to Week 24
Median Time to First Dose Reduction
Time to first dose reduction is defined as the time period from the first dose to the first dose reduction. Median time taken for the first dose reduction and 95% confidence interval will be calculated and reported.
Time frame: Baseline up to Week 24
Objective Response Rate (ORR)
ORR at 24 weeks is defined as the proportion of participants with best overall response of complete response (CR) or partial response (PR). CR is defined as disappearance of all target and non-target lesions. All lymph nodes must be non-pathological in size (less than \[\<\] 10 millimeter \[mm\] short axis). PR is defined as at least a 30 percent (%) decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. ORR = CR + PR.
Time frame: Week 24
Progression-free Survival (PFS)
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All India Institute of Medical Sciences
New Delhi, National Capital Territory of Delhi, India
Indraprastha Apollo Hospital
New Delhi, National Capital Territory of Delhi, India
All India Institute of Medical Sciences
Bhubaneshwar, Odisa, India
S. P. Medical College & A. G. Hospitals
Bikaner, Rajasthan, India
Tata Memorial Hospital
Mumbai, India
BL Kapoor Hospital, New Delhi
New Delhi, India
Indrayani Hospital, Alandi
Pune, India
...and 1 more locations
PFS is defined as the time from enrollment of participant in to study to the first sign of Progressive Disease (PD) or death due to any cause if the participant dies without experiencing PD. Disease progression per response evaluation criteria in solid tumor (RECIST) v1.1 was defined as at least a 20% relative increase and 5 mm absolute increase in the sum of diameters of target lesions (taking as reference the smallest sum on study) recorded since the treatment started or the appearance of 1 or more new lesions.
Time frame: From date of first dose of study drug until documentation of disease progression or death from any cause (whichever occurs first) or up to approximately Week 24
Percentage of Participants with Other TEAEs Below Grade 2
TEAEs are defined as undesirable events not present prior to medical treatment, or an already present event that worsens either in intensity or frequency following the treatment. The severity of all AEs will be graded according to CTCAE version 4.03 where grade 1: Asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated, grade 2: Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental ADL.
Time frame: Baseline up to Week 24