Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

An Open Label Phase I Dose Escalation Study Of E7080

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Eisai Inc.
ClinicalTrials.gov Identifier:
NCT00121719
First received: July 15, 2005
Last updated: April 19, 2016
Last verified: April 2016
Results First Received: April 19, 2016  
Study Type: Interventional
Study Design: Endpoint Classification: Safety Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Solid Tumor or Lymphoma
Intervention: Drug: Lenvatinib

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
0.2 mg Lenvatinib Two 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced dose-limiting toxicity (DLT) during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the maximum tolerated dose (MTD) was determined. An additional 12 participants were treated at the MTD level.
0.4 mg Lenvatinib Four 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
0.8 mg Lenvatinib Eight 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
1.6 mg Lenvatinib One 1.0 mg lenvatinib tablet and six 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
3.2 mg Lenvatinib Three 1.0 mg lenvatinib tablets and two 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
6.4 mg Lenvatinib Six 1.0 mg lenvatinib tablets and four 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
12 mg Lenvatinib One 10 mg lenvatinib tablet and two 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
12.5 mg Lenvatinib One 10 mg lenvatinib tablet, two 1.0 mg lenvatinib tablets, and five 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
16 mg Lenvatinib One 10 mg lenvatinib tablet and six 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
20 mg Lenvatinib Two 10 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
25 mg Lenvatinib Fasted/Fed Participants from the MTD Cohort who chose to participate in the food-effect pilot study were randomly assigned to this Cohort. Two 10 mg lenvatinib tablets and five 1.0 mg lenvatinib tablets were taken orally, once daily. The Day 15 dose of lenvatinib was taken in a fasted state and the Day 22 dose was taken in a fed state with a high fat meal. All other doses were taken on an empty stomach after waking, followed by fasting for 2 hours with only clear liquids allowed.
25 mg Lenvatinib Fed/Fasted Participants from the MTD Cohort who chose to participate in the food-effect pilot study were randomly assigned to this Cohort. Two 10 mg lenvatinib tablets and five 1.0 mg lenvatinib tablets were taken orally, once daily. The Day 15 dose of lenvatinib was taken in a fed state with a high fat meal and the Day 22 dose was taken in a fasted state. All other doses were taken on an empty stomach after waking, followed by fasting for 2 hours with only clear liquids allowed.
25 mg Lenvatinib (MTD Cohort) Participants in this cohort had the option of participating in the food-effect pilot study. Two 10 mg lenvatinib tablets and five 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
32 mg Lenvatinib Three 10 mg lenvatinib tablets and two 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.

Participant Flow:   Overall Study
    0.2 mg Lenvatinib     0.4 mg Lenvatinib     0.8 mg Lenvatinib     1.6 mg Lenvatinib     3.2 mg Lenvatinib     6.4 mg Lenvatinib     12 mg Lenvatinib     12.5 mg Lenvatinib     16 mg Lenvatinib     20 mg Lenvatinib     25 mg Lenvatinib Fasted/Fed     25 mg Lenvatinib Fed/Fasted     25 mg Lenvatinib (MTD Cohort)     32 mg Lenvatinib  
STARTED     4     4     4     3     3     3     12     9     6     3     6     5     24     7  
COMPLETED     0     0     0     0     0     0     0     0     0     0     0     0     0     0  
NOT COMPLETED     4     4     4     3     3     3     12     9     6     3     6     5     24     7  
Adverse Event                 0                 0                 1                 0                 0                 2                 2                 1                 0                 0                 1                 0                 3                 0  
Abnormal laboratory value                 1                 1                 0                 0                 0                 0                 0                 1                 0                 0                 0                 0                 1                 0  
Protocol deviation                 0                 0                 1                 0                 0                 0                 0                 0                 0                 0                 0                 0                 0                 0  
Withdrawal by Subject                 1                 0                 0                 0                 0                 0                 0                 0                 0                 0                 0                 0                 0                 0  
Progressive disease                 2                 1                 0                 2                 2                 1                 7                 5                 3                 1                 4                 3                 13                 4  
Clinical deterioration                 0                 1                 1                 0                 1                 0                 2                 1                 2                 2                 0                 1                 2                 2  
Physician Decision                 0                 1                 0                 0                 0                 0                 0                 0                 0                 0                 0                 0                 1                 0  
Not specified                 0                 0                 1                 1                 0                 0                 1                 0                 1                 0                 0                 0                 1                 1  
Continuing/ongoing patients                 0                 0                 0                 0                 0                 0                 0                 1                 0                 0                 1                 1                 3                 0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Intent-to-treat population included all participants who received at least one dose of lenvatinib.

Reporting Groups
  Description
0.2 mg Lenvatinib Two 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced dose-limiting toxicity (DLT) during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the maximum tolerated dose (MTD) was determined. An additional 12 participants were treated at the MTD level.
0.4 mg Lenvatinib Four 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
0.8 mg Lenvatinib Eight 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
1.6 mg Lenvatinib One 1.0 mg lenvatinib tablet and six 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
3.2 mg Lenvatinib Three 1.0 mg lenvatinib tablets and two 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
6.4 mg Lenvatinib Six 1.0 mg lenvatinib tablets and four 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
12 mg Lenvatinib One 10 mg lenvatinib tablet and two 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
12.5 mg Lenvatinib One 10 mg lenvatinib tablet, two 1.0 mg lenvatinib tablets, and five 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
16 mg Lenvatinib One 10 mg lenvatinib tablet and six 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
20 mg Lenvatinib Two 10 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
25 mg Lenvatinib Fasted/Fed Participants from the MTD Cohort who chose to participate in the food-effect pilot study were randomly assigned to this Cohort. Two 10 mg lenvatinib tablets and five 1.0 mg lenvatinib tablets were taken orally, once daily. The Day 15 dose of lenvatinib was taken in a fasted state and the Day 22 dose was taken in a fed state with a high fat meal. All other doses were taken on an empty stomach after waking, followed by fasting for 2 hours with only clear liquids allowed.
25 mg Lenvatinib Fed/Fasted Participants from the MTD Cohort who chose to participate in the food-effect pilot study were randomly assigned to this Cohort. Two 10 mg lenvatinib tablets and five 1.0 mg lenvatinib tablets were taken orally, once daily. The Day 15 dose of lenvatinib was taken in a fed state with a high fat meal and the Day 22 dose was taken in a fasted state. All other doses were taken on an empty stomach after waking, followed by fasting for 2 hours with only clear liquids allowed.
25 mg Lenvatinib (MTD Cohort) Participants in this cohort had the option of participating in the food-effect pilot study. Two 10 mg lenvatinib tablets and five 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
32 mg Lenvatinib Three 10 mg lenvatinib tablets and two 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
Total Total of all reporting groups

Baseline Measures
    0.2 mg Lenvatinib     0.4 mg Lenvatinib     0.8 mg Lenvatinib     1.6 mg Lenvatinib     3.2 mg Lenvatinib     6.4 mg Lenvatinib     12 mg Lenvatinib     12.5 mg Lenvatinib     16 mg Lenvatinib     20 mg Lenvatinib     25 mg Lenvatinib Fasted/Fed     25 mg Lenvatinib Fed/Fasted     25 mg Lenvatinib (MTD Cohort)     32 mg Lenvatinib     Total  
Number of Participants  
[units: participants]
  4     4     4     3     3     3     12     9     6     3     6     5     24     7     93  
Age  
[units: Years]
Mean (Standard Deviation)
  64.5  (7.94)     47.8  (6.45)     64.0  (6.48)     60.0  (11.53)     65.0  (19.00)     51.0  (22.72)     46.3  (13.25)     52.6  (13.28)     55.7  (13.32)     51.7  (12.34)     52.3  (9.99)     49.4  (11.06)     52.2  (9.65)     53.9  (11.84)     53.4  (12.32)  
Gender  
[units: Participants]
                             
Female     2     3     2     1     2     0     8     3     3     0     3     3     14     1     45  
Male     2     1     2     2     1     3     4     6     3     3     3     2     10     6     48  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Maximum Tolerated Dose (MTD)   [ Time Frame: Cycle 1 (4 weeks) ]

2.  Secondary:   Summary of Adverse Events (AEs) and Serious Adverse Events (SAEs)   [ Time Frame: First date of study treatment to date of last dose of study treatment, up to approximately 4 years ]

3.  Secondary:   Dose-limiting Toxicities (DLTs)   [ Time Frame: Cycle 1 (4 weeks) of each dose level ]

4.  Secondary:   Treatment-Related Adverse Events (All Grades) With an Overall Incidence Greater Than or Equal to 10%   [ Time Frame: First date of study treatment to date of withdrawal from study or last dose of study treatment, up to approximately 4 years ]

5.  Secondary:   Best Overall Response (BOR)   [ Time Frame: Baseline to first date of documented CR, PR, SD, or PD, assessed up to approximately 4 years ]

6.  Secondary:   Maximum Plasma Concentration (Cmax) of Lenvatinib   [ Time Frame: Cycle 1 Day 1 (C1D1), Cycle 2 Day 1 (C2D1) ]

7.  Secondary:   Time to Maximum Plasma Concentration (Tmax) of Lenvatinib   [ Time Frame: Cycle 1 Day 1 (C1D1), Cycle 2 Day 1 (C2D1) ]

8.  Secondary:   Apparent Plasma Half-life (t1/2) of Lenvatinib   [ Time Frame: Cycle 1 Day 1 (C1D1), Cycle 2 Day 1 (C2D1) ]

9.  Secondary:   Area Under the Plasma Concentration Curve From Time 0 to Infinity (AUC(0-inf))   [ Time Frame: Cycle 1 Day 1 (C1D1), Cycle 2 Day 1 (C2D1) ]

10.  Secondary:   Area Under the Plasma Concentration Curve From Time 0 to 24 Hours (AUC(0-24))   [ Time Frame: Cycle 1 Day 1 (C1D1), Cycle 2 Day 1 (C2D1) ]

11.  Secondary:   Clearance Corrected for the Fraction of Lenvatinib Absorbed (CL/F)   [ Time Frame: Cycle 1 Day 1 (C1D1), Cycle 2 Day 1 (C2D1) ]

12.  Secondary:   Apparent Volume of Distribution (Vz/F)   [ Time Frame: Cycle 1 Day 1 (C1D1), Cycle 2 Day 1 (C2D1) ]

13.  Secondary:   Fraction of Unchanged Lenvatinib Excreted in the Urine (fe)   [ Time Frame: Cycle 1 Day 1 (C1D1), Cycle 2 Day 1 (C2D1) ]

14.  Secondary:   Renal Clearance (CLr) of Lenvatinib   [ Time Frame: Cycle 1 Day 1 (C1D1), Cycle 2 Day 1 (C2D1) ]

15.  Secondary:   Effect of Food on the Area Under the Curve From Zero to 24 Hours (AUC(0-24))   [ Time Frame: Cycle 1 Day 15 and Day 22 ]

16.  Secondary:   Effect of Food on the Maximum Plasma Concentration (Cmax) of Lenvatinib   [ Time Frame: Cycle 1 Day 1, Day 15 and Day 22 ]

17.  Secondary:   Effect of Food on Time to Maximum Concentration (Tmax) of Lenvatinib   [ Time Frame: Cycle 1 Day 1, Day 15, and Day 22 ]

18.  Other Pre-specified:   Pharmacodynamic (PD) Biomarkers of Lenvatinib in Peripheral Blood Mononuclear Cells (PBMCs) and Tumor Samples   [ Time Frame: Blood: Cycle 1 Day 1, Day 15, or Day 22, Cycle 2 Day 1 Tumor tissue: Screening and after at least one 28-day Cycle of study treatment ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No


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  Other Adverse Events


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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Eisai Medical Services
Organization: Eisai Inc.
phone: 888-422-4743



Responsible Party: Eisai Inc.
ClinicalTrials.gov Identifier: NCT00121719     History of Changes
Other Study ID Numbers: E7080-E044-101
Study First Received: July 15, 2005
Results First Received: April 19, 2016
Last Updated: April 19, 2016
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency