Trial · NCT02702388
A Trial of Lenvatinib (E7080) in Subjects With Iodine-131 Refractory Differentiated Thyroid Cancer to Evaluate Whether an Oral Starting Dose of 18 Milligram (mg) Daily Will Provide Comparable Efficacy to a 24 mg Starting Dose, But Have a Better Safety Profile
NCT02702388, Phase 2, Completed, Eisai Inc.; results first posted 2021-01-11
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Trial of Lenvatinib (E7080) in Subjects With Iodine-131 Refractory Differentiated Thyroid Cancer to Evaluate Whether an Oral Starting Dose of 18 Milligram (mg) Daily Will Provide Comparable Efficacy to a 24 mg Starting Dose, But Have a Better Safety Profile. Trials, record NCT02702388. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02702388
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
A Trial of Lenvatinib (E7080) in Subjects With Iodine-131 Refractory Differentiated Thyroid Cancer to Evaluate Whether an Oral Starting Dose of 18 Milligram (mg) Daily Will Provide Comparable Efficacy to a 24 mg Starting Dose, But Have a Better Safety Profile
- NCT number
- NCT02702388
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 241 participants, actual
- Lead sponsor
- Eisai Inc.
- Conditions
- Thyroid Cancer
- Interventions
- Lenvatinib, Lenvatinib matching placebo
- First posted
- 2016-03-08
- Last updated
- 2021-11-24
- Other registries' IDs
- eudract:2014-005199-27
- Results first posted
- 2021-01-11
Source ClinicalTrials.gov
Registered outcomes33
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Objective Response Rate (ORR) as of Week 24 (ORR24wk) | From the date of randomization up to Week 24 | ORR as of Week 24 was defined as the percentage of participants with best overall response (BOR) of complete response (CR) or partial response (PR) as of the Week 24 time point or earlier, as measured by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1). CR: was disappearance of all target lesions. Any pathological lymph nodes (target or non-target) had to be reduced in short axis to less than (\<) 10 millimeter (mm). PR: was at least a 30 percent (%) decrease in sum of diameter (SOD) of target lesions, taking as reference the baseline SOD. |
| Primary | Percentage of Participants With Grade 3 or Higher Treatment-emergent Adverse Events (TEAEs) in the First 24 Weeks | Baseline up to Week 24 | This outcome measure reports TEAEs in the first 24 weeks only. A TEAE was defined as any adverse event (AE) that had an onset date on or after the first dose of study drug up to 28 days following the last dose of study drug, or a worsening in severity from Baseline (pretreatment). In addition, if an AE reemerged during treatment, having been present at pretreatment (Baseline) but stopped before treatment, it was also counted as a TEAE. A severity grade was defined by the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03. As per CTCAE, Grade 1 scales as Mild; Grade 2 scales as Moderate; Grade 3 scales as severe or medically significant but not immediately life threatening; Grade 4 scales as life-threatening consequences; and Grade 5 scales as death related to AE. |
| Secondary | Progression-free Survival (PFS) | Time from the date of randomization to the date of first documentation of PD, or date of death, whichever occurs first up to approximately 2 years 6 months | PFS, defined as the time from the date of randomization to the date of first documentation of PD, or date of death, whichever occurs first, as measured by RECIST V1.1. PD: 20% increase in the sum of the pertinent diameters (SOD) of target lesions, taking as reference the smallest sum SOD recorded since the treatment started or the appearance of one or more new lesions. PFS was analyzed using the Kaplan-Meier method. As planned, data for this endpoint was analyzed and collected till Primary completion date. |
| Secondary | PFS After Next Line of Treatment (PFS2) | Time from randomization to PD on next-line treatment or death from any cause, whichever occurs first up to approximately 2 years 6 months | PFS2, defined as the time from randomization to PD on next-line treatment, or death from any cause, whichever occurred first, as measured by RECIST V1.1. PD: 20% increase in the SOD of target lesions, taking as reference the smallest sum SOD recorded since the treatment started or the appearance of one or more new lesions. PFS was analyzed using the Kaplan-Meier method. As planned, data for this endpoint was analyzed and collected till Primary completion date. |
| Secondary | Number of Participants With TEAE and Serious Adverse Events (SAEs) | From date of first administration of study drug up to 28 days after last dose of study drug up to approximately 3 years 3 months | TEAEs were defined as those AEs that occurred (or worsened, if present at Baseline) after the first dose of study drug through 28 days after the last dose of study drug. An AE was defined as any untoward medical occurrence in a participants or clinical investigation participant administered an investigational product. An AE does not necessarily have a causal relationship with medicinal product. SAE was defined as any AE if it resulted in death or life-threatening AE or required inpatient hospitalization or prolongation of existing hospitalization or resulted in persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions or was a congenital anomaly/birth defect. |
| Secondary | Time to Treatment Discontinuation Due to an Adverse Event (AE) | From date of first administration of study drug up to approximately 2 years 6 months | Time to Treatment Discontinuation due to an AE (such as abdominal distention, appendicitis perforated, arthralgia, anemia, etc) was analyzed using the Kaplan-Meier method. As planned, data for this endpoint was analyzed and collected till Primary completion date. |
| Secondary | Number of Dose Reductions | From date of first administration of study drug up to approximately 2 years 6 months | Number of dose reduction was reported as number of participants who underwent one or more number of dose reductions. As planned, data for this endpoint was analyzed and collected till Primary completion date. |
| Secondary | Time to First Dose Reduction | From date of first administration of study drug up to approximately 2 years 6 months | Time to First Dose Reduction was analyzed using the Kaplan-Meier method. As planned, data for this endpoint was analyzed and collected till Primary completion date. |
| Secondary | Model Predicted Apparent Total Clearance (CL/F) Following Oral Dosing of Lenvatinib | Cycle 1 Day 1: 0.5-4 hours and 6-10 hours postdose; Cycle 1 Day 8: predose, Cycle 1 Day 15: predose, 0.5-4 hours and 6-10 hours postdose; Cycle 1 Day 22: optionally at predose; Cycle 2 Day 1: predose and 2-12 hours postdose (Cycle length=28 days) | Sparse pharmacokinetic (PK) samples (approximately 9 per participant) were collected and analyzed using a population PK approach to estimate PK parameters. Lenvatinib total plasma concentration data were pooled with data from studies E7080-G000-303 (NCT01321554) and E7080-G000-201 (NCT00784303), and a population PK model was applied to the pooled dataset. Individual predicted CL/F for lenvatinib was then derived from the PK model by starting dose. |
| Secondary | Model Predicted Area Under the Plasma Drug Concentration-time Curve (AUC) for Lenvatinib | Cycle 1 Day 1: 0.5-4 hours and 6-10 hours postdose; Cycle 1 Day 8: predose, Cycle 1 Day 15: predose, 0.5-4 hours and 6-10 hours postdose; Cycle 1 Day 22: optionally at predose; Cycle 2 Day 1: predose and 2-12 hours postdose (Cycle length=28 days) | Sparse PK samples (approximately 9 per participant) were collected and analyzed using a population PK approach to estimate PK parameters. Lenvatinib total plasma concentration data were pooled with data from studies E7080-G000-303 (NCT01321554) and E7080-G000-201 (NCT00784303), and a population PK model was applied to the pooled dataset. Individual predicted AUC for lenvatinib was then derived from the PK model by starting dose. |
1 to 10 of 33Source ClinicalTrials.gov
See all 33 registered outcomesOutcomes33
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Objective Response Rate (ORR) as of Week 24 (ORR24wk) | From the date of randomization up to Week 24 | FAS included all participants randomly assigned to treatment. | percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants With Grade 3 or Higher Treatment-emergent Adverse Events (TEAEs) in the First 24 Weeks | Baseline up to Week 24 | Safety analysis set included all participants randomly assigned to treatment and who received at least 1 dose of study drug. | percentage of participants | NUMBER |
| SECONDARY | Progression-free Survival (PFS) | Time from the date of randomization to the date of first documentation of PD, or date of death, whichever occurs first up to approximately 2 years 6 months | FAS included all participants randomly assigned to treatment. | months | MEDIAN |
| SECONDARY | PFS After Next Line of Treatment (PFS2) | Time from randomization to PD on next-line treatment or death from any cause, whichever occurs first up to approximately 2 years 6 months | FAS included all participants randomly assigned to treatment. | months | MEDIAN |
| SECONDARY | Number of Participants With TEAE and Serious Adverse Events (SAEs) | From date of first administration of study drug up to 28 days after last dose of study drug up to approximately 3 years 3 months | Safety analysis set included all participants randomly assigned to treatment and who received at least 1 dose of study drug. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Time to Treatment Discontinuation Due to an Adverse Event (AE) | From date of first administration of study drug up to approximately 2 years 6 months | Safety analysis set included all participants randomly assigned to treatment and who received at least 1 dose of study drug. | weeks | MEDIAN |
| SECONDARY | Number of Dose Reductions | From date of first administration of study drug up to approximately 2 years 6 months | Safety analysis set included all participants randomly assigned to treatment and who received at least 1 dose of study drug. Here overall number of participants analyzed signifies participants who were evaluable for this outcome measure. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Time to First Dose Reduction | From date of first administration of study drug up to approximately 2 years 6 months | Safety analysis set included all participants randomly assigned to treatment and who received at least 1 dose of study drug. | weeks | MEDIAN |
| SECONDARY | Model Predicted Apparent Total Clearance (CL/F) Following Oral Dosing of Lenvatinib | Cycle 1 Day 1: 0.5-4 hours and 6-10 hours postdose; Cycle 1 Day 8: predose, Cycle 1 Day 15: predose, 0.5-4 hours and 6-10 hours postdose; Cycle 1 Day 22: optionally at predose; Cycle 2 Day 1: predose and 2-12 hours postdose (Cycle length=28 days) | PK Analysis Set included all participants who received at least one dose of study drug and who had evaluable lenvatinib plasma concentration data. Population for Lenvatinib 24 mg arm for this outcome measure included participants from study E7080-G000-303 (NCT01321554), E7080-G000-201 (NCT00784303) and from this current study E7080-G000-211. Here overall number of participants analyzed signifies participants who were evaluable for this outcome measure. | liter per hour (L/h) | MEAN |
| SECONDARY | Model Predicted Area Under the Plasma Drug Concentration-time Curve (AUC) for Lenvatinib | Cycle 1 Day 1: 0.5-4 hours and 6-10 hours postdose; Cycle 1 Day 8: predose, Cycle 1 Day 15: predose, 0.5-4 hours and 6-10 hours postdose; Cycle 1 Day 22: optionally at predose; Cycle 2 Day 1: predose and 2-12 hours postdose (Cycle length=28 days) | PK Analysis Set included all participants who received at least one dose of study drug and who had evaluable lenvatinib plasma concentration data. Population for Lenvatinib 24 mg arm for this outcome measure included participants from study E7080-G000-303 (NCT01321554), E7080-G000-201 (NCT00784303) and from this current study E7080-G000-211. Here overall number of participants analyzed signifies participants who were evaluable for this outcome measure. | nanogram*hour per milliliter (ng*h/mL) | MEAN |
1 to 10 of 33Source ClinicalTrials.gov
See all 33 outcomesResults by group196
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Objective Response Rate (ORR) as of Week 24 (ORR24wk) | Lenvatinib 24 mg | 57.3 | 95% Confidence Interval 46.1 to 68.5 | percentage of participants | |
| Objective Response Rate (ORR) as of Week 24 (ORR24wk) | Lenvatinib 18 mg | 40.3 | 95% Confidence Interval 29.3 to 51.2 | percentage of participants | |
| Percentage of Participants With Grade 3 or Higher Treatment-emergent Adverse Events (TEAEs) in the First 24 Weeks | Lenvatinib 24 mg | 61.3 | percentage of participants | ||
| Percentage of Participants With Grade 3 or Higher Treatment-emergent Adverse Events (TEAEs) in the First 24 Weeks | Lenvatinib 18 mg | 57.1 | percentage of participants | ||
| Progression-free Survival (PFS) | Lenvatinib 24 mg | NA | 95% Confidence Interval 22.1 to NA | months | |
| Progression-free Survival (PFS) | Lenvatinib 18 mg | 24.4 | 95% Confidence Interval 14.7 to NA | months | |
| PFS After Next Line of Treatment (PFS2) | Lenvatinib 24 mg | NA | 95% Confidence Interval NA to NA | months | |
| PFS After Next Line of Treatment (PFS2) | Lenvatinib 18 mg | NA | 95% Confidence Interval 22.1 to NA | months | |
| Number of Participants With TEAE and Serious Adverse Events (SAEs) | Lenvatinib 24 mg | TEAE | 75 | Participants | |
| Number of Participants With TEAE and Serious Adverse Events (SAEs) | Lenvatinib 18 mg | TEAE | 76 | Participants |
1 to 10 of 196Source ClinicalTrials.gov
See all 196 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Lenvatinib 24 mg | 75 | |
| Overall Study | STARTED | Lenvatinib 18 mg | 77 | |
| Overall Study | COMPLETED | Lenvatinib 24 mg | 35 | |
| Overall Study | COMPLETED | Lenvatinib 18 mg | 26 | |
| Overall Study | NOT COMPLETED | Lenvatinib 24 mg | 40 | |
| Overall Study | NOT COMPLETED | Lenvatinib 18 mg | 51 |
Source ClinicalTrials.gov
Adverse events1,082
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | Lenvatinib 24 mg | 5 | 75 | 5 |
| other | Anaemia | Blood and lymphatic system disorders | Lenvatinib 18 mg | 8 | 77 | 13 |
| other | Increased tendency to bruise | Blood and lymphatic system disorders | Lenvatinib 24 mg | 1 | 75 | 1 |
| other | Increased tendency to bruise | Blood and lymphatic system disorders | Lenvatinib 18 mg | 1 | 77 | 1 |
| other | Leukocytosis | Blood and lymphatic system disorders | Lenvatinib 24 mg | 1 | 75 | 2 |
| other | Leukocytosis | Blood and lymphatic system disorders | Lenvatinib 18 mg | 0 | 77 | 0 |
| other | Leukopenia | Blood and lymphatic system disorders | Lenvatinib 24 mg | 2 | 75 | 3 |
| other | Leukopenia | Blood and lymphatic system disorders | Lenvatinib 18 mg | 3 | 77 | 8 |
| other | Lymphopenia | Blood and lymphatic system disorders | Lenvatinib 24 mg | 0 | 75 | 0 |
| other | Lymphopenia | Blood and lymphatic system disorders | Lenvatinib 18 mg | 4 | 77 | 12 |
1 to 10 of 1,082Source ClinicalTrials.gov
See all 1,082 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Lenvatinib 24 mg | 11 | 75 |
| Total, all-cause mortality | Lenvatinib 18 mg | 19 | 77 |
| Total, other adverse events | Lenvatinib 24 mg | 75 | 75 |
| Total, other adverse events | Lenvatinib 18 mg | 76 | 77 |
| Total, serious adverse events | Lenvatinib 24 mg | 26 | 75 |
| Total, serious adverse events | Lenvatinib 18 mg | 35 | 77 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Lenvatinib 24 mg vs Lenvatinib 18 mg: deaths from any cause | Trial comparisons |
| Lenvatinib 24 mg vs Lenvatinib 18 mg: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02702388
GET https://conductscience.org/api/trials/v1/NCT02702388/registered?page=2