Phase 1 study to investigate the tolerability and safety of lenvatinib in combination with Everolimus in participants with unresectable advanced or metastatic RCC.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
7
Eisai Trial Site #1
Chiba, Japan
Eisai Trial Site #1
Tokyo, Japan
Eisai Trial Site #2
Tokyo, Japan
Number of Participants Who Experienced Any Dose Limiting Toxicity (DLT)
DLT was defined as toxicity related to the combination therapy and was graded according to Common Terminology Criteria for Adverse Events version 4.03 (CTCAE v4.03).
Time frame: From first dose of study drug up to Cycle 1 Day 28 (Cycle length=28 days)
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Time frame: Baseline up to 30 days after the last dose of study drug (up to approximately 21.5 months)
Cmax: Maximum Observed Plasma Concentration for Levatinib and Everolimus
Time frame: Cycle 1 Day 1 predose and at 1, 2, 4 ,8, and 24 hours postdose (Cycle length=28 days)
Css,Max: Maximum Observed Plasma Concentration at Steady State for Levatinib and Everolimus
Time frame: Cycle 1 Day 15 predose and at 1, 2, 4 ,8, and 24 hours postdose (Cycle length=28 days)
Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for Levatinib and Everolimus
Time frame: Cycle 1 Day 1 predose and at 1, 2, 4 ,8, and 24 hours postdose (Cycle length=28 days)
Tss,Max: Time to Reach the Maximum Plasma Concentration (Cmax) at Steady State for Levatinib and Everolimus
Time frame: Cycle 1 Day 15 predose and at 1, 2, 4 ,8, and 24 hours postdose (Cycle length=28 days)
AUC 0-t: Area Under the Concentration-time Curve From Zero (Pre-dose) to Time of Last Quantifiable Concentration for Levatinib and Everolimus
Time frame: Cycle 1 Day 1 and Cycle 1 Day 15 predose and at 1, 2, 4 ,8, and 24 hours postdose (Cycle length=28 days)
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Number of Participants With Best Overall Response (BOR)
BOR included complete response (CR), partial response (PR), stable disease (SD), and PD (progressive disease). BOR was assessed using Response Evaluation Criteria in Solid Tumor (RECIST) 1.1
Time frame: From first dose of study drug until PD, development of unacceptable toxicity, participant requests to discontinue, withdrawal of consent or study termination (up to approximately 23 months)
Objective Response Rate (ORR)
ORR was defined as the percentage of participants who achieved BOR of CR or PR. ORR was assessed using RECIST 1.1.
Time frame: From first dose of study drug until PD, development of unacceptable toxicity, participant requests to discontinue, withdrawal of consent or study termination (up to approximately 23 months)
Disease Control Rate (DCR)
DCR was defined as the percentage of participants who achieved BOR of CR, PR, or SD. DCR was assessed based on RECIST 1.1.
Time frame: From first dose of study drug until PD, development of unacceptable toxicity, participant requests to discontinue, withdrawal of consent or study termination (up to approximately 23 months)
Number of Participants With the Minimum Percent Change From Baseline in the Sum of Diameters of Target Lesions
Time frame: Baseline up to first tumor assessment at which diameter of target lesions were available (up to approximately 23 months)