Trial · NCT00784303
Evaluating the Safety and Efficacy of Oral Lenvatinib in Medullary and Iodine-131 Refractory, Unresectable Differentiated Thyroid Cancers, Stratified by Histology
NCT00784303, Phase 2, Completed, Eisai Inc.; results first posted 2019-08-01
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Evaluating the Safety and Efficacy of Oral Lenvatinib in Medullary and Iodine-131 Refractory, Unresectable Differentiated Thyroid Cancers, Stratified by Histology. Trials, record NCT00784303. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00784303
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Evaluating the Safety and Efficacy of Oral Lenvatinib in Medullary and Iodine-131 Refractory, Unresectable Differentiated Thyroid Cancers, Stratified by Histology
- NCT number
- NCT00784303
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 117 participants, actual
- Lead sponsor
- Eisai Inc.
- Conditions
- Thyroid Cancer
- Interventions
- Lenvatinib (DTC Cohort), Lenvatinib (MTC Cohort)
- First posted
- 2008-11-03
- Last updated
- 2020-04-22
- Results first posted
- 2019-08-01
Source ClinicalTrials.gov
Registered outcomes17
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Objective Response Rate (ORR) | From date of treatment start until disease progression, development of unacceptable toxicity, withdrawal of consent, participant's choice to stop study treatment, or up to data cutoff date 11 April 2011, for up to approximately 2 years 5 months | ORR was the percentage of participants with best overall response (BOR) of complete response (CR) and partial response (PR) based on modified Response Evaluation Criteria in Solid Tumors (RECIST) 1.0 for target lesions using magnetic resonance imaging/computed tomography (MRI/CT) scans, as determined by independent imaging review (IIR). CR was defined as disappearance of all target lesions. PR was defined as at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum of the longest diameter. ORR=CR+PR, was presented with 2-sided 95% confidence interval (CI) by the method of Clopper and Pearson. |
| Primary | Plasma Pharmacokinetics (PK): Steady State Area Under the Plasma Concentration Curve (AUC) | Cycle 1 Day 1 (predose and at 0.5 and 2 hours postdose), Cycle 1 Day 8 (predose), Cycle 2 Day 1 (predose and at 0.5 and 2 hours postdose), and Cycle 3 Day 1 (predose and at 2 hours postdose) (Cycle length= 28 days) | Up to 9 samples per participant were obtained at specific time points. Plasma concentrations of lenvatinib were analyzed using standard analysis methods. Due to the sparse PK sampling in this study, the data were pooled with data from other Phase 1 studies conducted in participants with solid tumors for PK model development and covariate analysis. Individual exposure (steady state AUC) to lenvatinib in MTC and DTC subjects in this study was derived based on the individual predicted steady state AUC from the final PK model. Only data for participants taking 24 mg lenvatinib daily were reported (participants taking 20 mg lenvatinib daily were not included in this data set). |
| Secondary | Change From Baseline in Free Thyroxine (T4) | Day 1 or within 72 hours prior to Day 1 of Cycles 2 to 20, and Final Visit, up to data cutoff date 11 April 2011 (Cycle length= 28 days) | Blood samples to measure free T4 were collected at Screening (Baseline), Cycle 1 Day 15 (MTC cohort), Day 1 of Cycles 2 to 20, and Final Visit. Changes in free T4 concentration values from baseline to specific time points were calculated. Only participants with both baseline and relevant visit values were included. |
| Secondary | Change From Baseline in Free Thyroid Stimulating Hormone (TSH) | Day 1 or within 72 hours prior to Day 1 of Cycles 2 to 20, and Final Visit, up to data cutoff date 11 April 2011 (Cycle length= 28 days) | Blood samples to measure free TSH were collected at Screening (Baseline), Cycle 1 Day 15 (MTC cohort), Day 1 of Cycles 2 to 20, and Final Visit. Changes in free TSH concentration values from baseline to specific time points were calculated. Only participants with both baseline and relevant visit values were included. For any free TSH result that was reported as \<0.008 mIU/L, 0.004 mIU/L was used for calculating summary statistics. |
| Secondary | Percent Change From Baseline in Concentrations of Thyroglobulin (DTC Only) | Day 1 or within 72 hours prior to Day 1 of Cycles 2 to 19, and Final Visit, up to data cutoff date 11 April 2011 (Cycle length= 28 days) | Blood samples to obtain serum were collected at Cycle 1 Day 1 (Baseline), Day 1 of Cycles 2 to 19, Final Visit, and were analyzed for thyroglobulin concentration. Percent changes in thyroglobulin concentration values from baseline to specific time points were calculated. Only participants with both baseline and relevant visit values were included. |
| Secondary | Percent Change From Baseline in Concentrations of Calcitonin (MTC Only) | Day 1 or within 72 hours prior to Day 1 of Cycles 2 to 20, and Final Visit, up to data cutoff date 11 April 2011 (Cycle length= 28 days) | Blood samples to obtain serum were collected at Cycle 1 Day 1(Baseline), Day 1 of Cycles 2 to 20, Final Visit, and were analyzed for calcitonin concentration. Percent changes in calcitonin concentration values from baseline to specific time points were calculated. Only participants with both baseline and relevant visit values were included. |
| Secondary | Percent Change From Baseline in Concentrations of Carcinoembryonic Antigen (CEA) (MTC Only) | Day 1 or within 72 hours prior to Day 1 of Cycles 2 to 20, and Final Visit, up to data cutoff date 11 April 2011 (Cycle length= 28 days) | Blood samples were collected at Cycle 1 Day 1(Baseline), Day 1 of Cycles 2 to 20, Final Visit, and were analyzed for CEA concentration. Percent changes in CEA concentration values from baseline to specific time points were calculated. Only participants with both baseline and relevant visit values were included. |
| Secondary | Change From Baseline in Concentrations of Cytochrome C (CytoC) | Cycle 1 (Day 8), Cycle 2 (Days 1, 8 and 15), Cycles 3, 4, 5, 6, 7, 8, 9, 11, & 13 (Day 1), and Final Visit, up to data cutoff date 11 April 2011 (Cycle length= 28 days) | Blood samples to obtain serum were collected at Cycle 1 Day 1(Baseline), Cycle 1 Day 8, Cycle 2 Days 1,8 \&15, Cycles 3 to 9,11,13 Day 1, Final Visit, and analyzed for CytoC concentration. Changes in CytoC concentration values from baseline to specific time points were calculated. Only participants with both baseline and relevant visit values were included. For results reported as below quantifiable level (BQL), zero was used for calculating summary statistics. If more than 50% of the results at a visit were BQL, then only 'n', 'minimum' and 'maximum' were calculated for summary statistics. |
| Secondary | Change From Baseline in Concentrations of M-30 Neo-Antigen | Cycle 1 (Day 8), Cycle 2 (Days 1, 8 & 15), Cycles 3, 4, 5, 6, 7, 8, 9, 11 & 13 (Day 1) and Final Visit, up to data cutoff date 11 April 2011 (Cycle length= 28 days) | Blood samples to obtain serum were collected at Cycle 1 Day 1(Baseline), Cycle 1 Day 8, Cycle 2 Days 1,8 \&15, Cycles 3 to 9,11,13 Day 1, Final Visit, and analyzed for M-30 concentration. Changes in M-30 concentration values from baseline to specific time points were calculated. Only participants with both baseline and relevant visit values were included. For results reported as BQL, zero was used for calculating summary statistics. If more than 50% of the results at a visit were BQL, then only 'n', 'minimum' and 'maximum' were calculated for summary statistics. |
| Secondary | Change From Baseline in Concentrations of Activated Caspase 3/7 (Casp 3/7) | Cycle 1 (Day 8), Cycle 2 (Days 1, 8, & 15), Cycles 3, 4, 5, 6, 7, 8, 9, 11, & 13 (Day 1) and Final Visit, up to data cutoff date 11 April 2011 (Cycle length= 28 days) | Blood samples to obtain serum were collected at Cycle 1 Day 1 (Baseline), Cycle 1 Day 8, Cycle 2 Days 1, 8, and 15, Cycles 3 to 9, 11, 13 (Day 1), Final Visit, and analyzed for Casp 3/7 concentration. Changes in Casp 3/7 concentration values from baseline to specific time points were calculated. Only participants with both baseline and relevant visit values were included. The concentrations of Casp 3/7 were BQL for most participants at most time points. For results reported as BQL, zero was used for calculating summary statistics. If more than 50% of the results at a visit were BQL, then only 'n', 'minimum' and 'maximum' were calculated for summary statistics. |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 registered outcomesOutcomes17
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) | From date of treatment start until disease progression, development of unacceptable toxicity, withdrawal of consent, participant's choice to stop study treatment, or up to data cutoff date 11 April 2011, for up to approximately 2 years 5 months | The Intent to Treat (ITT) Population included all participants who received at least one dose of the study drug and was the primary analysis set used for efficacy analyses. | Percentage of participants | NUMBER |
| PRIMARY | Plasma Pharmacokinetics (PK): Steady State Area Under the Plasma Concentration Curve (AUC) | Cycle 1 Day 1 (predose and at 0.5 and 2 hours postdose), Cycle 1 Day 8 (predose), Cycle 2 Day 1 (predose and at 0.5 and 2 hours postdose), and Cycle 3 Day 1 (predose and at 2 hours postdose) (Cycle length= 28 days) | PK population included all participants who received the 24 mg daily lenvatinib dose and had concentration values above the limit of quantification and non-missing PK sampling/dose time. | ng·h/mL | MEDIAN |
| SECONDARY | Change From Baseline in Free Thyroxine (T4) | Day 1 or within 72 hours prior to Day 1 of Cycles 2 to 20, and Final Visit, up to data cutoff date 11 April 2011 (Cycle length= 28 days) | All participants who received at least 1 dose of study drug. Only participants with both baseline and relevant visit/time point values were included. Data not reported for DTC cohort at Cycle 1 Day 15 and Cycle 20 Day 1 because no participant was evaluable at these time points. | pmol/L | MEAN |
| SECONDARY | Change From Baseline in Free Thyroid Stimulating Hormone (TSH) | Day 1 or within 72 hours prior to Day 1 of Cycles 2 to 20, and Final Visit, up to data cutoff date 11 April 2011 (Cycle length= 28 days) | All participants who received at least 1 dose of study drug. For each change from baseline assessment time point, only participants with both baseline and relevant visit/time point values were included. Data not reported for DTC cohort at Cycle 1 Day 15 and Cycle 20 Day 1 because no participant was evaluable at these time points. | mIU/L | MEAN |
| SECONDARY | Percent Change From Baseline in Concentrations of Thyroglobulin (DTC Only) | Day 1 or within 72 hours prior to Day 1 of Cycles 2 to 19, and Final Visit, up to data cutoff date 11 April 2011 (Cycle length= 28 days) | All participants who received at least 1 dose of study drug. For each change from baseline assessment time point, only participants with both baseline and relevant visit/time point values were included. | percent change | MEAN |
| SECONDARY | Percent Change From Baseline in Concentrations of Calcitonin (MTC Only) | Day 1 or within 72 hours prior to Day 1 of Cycles 2 to 20, and Final Visit, up to data cutoff date 11 April 2011 (Cycle length= 28 days) | All participants who received at least 1 dose of study drug. For each change from baseline assessment time point, only participants with both baseline and relevant visit/time point values were included. | percent change | MEAN |
| SECONDARY | Percent Change From Baseline in Concentrations of Carcinoembryonic Antigen (CEA) (MTC Only) | Day 1 or within 72 hours prior to Day 1 of Cycles 2 to 20, and Final Visit, up to data cutoff date 11 April 2011 (Cycle length= 28 days) | All participants who received at least 1 dose of study drug. For each change from baseline assessment time point, only participants with both baseline and relevant visit/time point values were included. | percent change | MEAN |
| SECONDARY | Change From Baseline in Concentrations of Cytochrome C (CytoC) | Cycle 1 (Day 8), Cycle 2 (Days 1, 8 and 15), Cycles 3, 4, 5, 6, 7, 8, 9, 11, & 13 (Day 1), and Final Visit, up to data cutoff date 11 April 2011 (Cycle length= 28 days) | All participants who received at least 1 dose of study drug. Only participants with both baseline and relevant visit/time point values were included. Data not reported for DTC cohort at Cycle 2 Day 1, for MTC cohort at Cycle 2 Day 15, Day 1 of Cycle 11 and 13 because no participant was evaluable at these time points. | pg/mL | MEAN |
| SECONDARY | Change From Baseline in Concentrations of M-30 Neo-Antigen | Cycle 1 (Day 8), Cycle 2 (Days 1, 8 & 15), Cycles 3, 4, 5, 6, 7, 8, 9, 11 & 13 (Day 1) and Final Visit, up to data cutoff date 11 April 2011 (Cycle length= 28 days) | All participants who received at least 1 dose of study drug. Only participants with both baseline and relevant visit/time point values were included. Data not reported for DTC cohort at Cycle 2 Day 1, for MTC cohort at Cycle 2 Day 15, Day 1 of Cycle 11 and 13 because no participant was evaluable at these time points. | U/L | MEAN |
| SECONDARY | Change From Baseline in Concentrations of Activated Caspase 3/7 (Casp 3/7) | Cycle 1 (Day 8), Cycle 2 (Days 1, 8, & 15), Cycles 3, 4, 5, 6, 7, 8, 9, 11, & 13 (Day 1) and Final Visit, up to data cutoff date 11 April 2011 (Cycle length= 28 days) | All participants who received at least 1 dose of study drug. Only participants with both baseline and relevant visit/time point values were included. Data not reported for DTC cohort at Cycle 2 Day 1, for MTC cohort at Cycle 2 Day 15, Day 1 of Cycle 11 and 13 because no participant was evaluable at these time points. | U/W | MEAN |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 outcomesResults by group231
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) | DTC Cohort | 50.0 | 95% Confidence Interval 36.6 to 63.4 | Percentage of participants | |
| Objective Response Rate (ORR) | MTC Cohort | 35.6 | 95% Confidence Interval 23.6 to 49.1 | Percentage of participants | |
| Plasma Pharmacokinetics (PK): Steady State Area Under the Plasma Concentration Curve (AUC) | DTC Cohort | 3840 | Full Range 1610 to 6960 | ng·h/mL | |
| Plasma Pharmacokinetics (PK): Steady State Area Under the Plasma Concentration Curve (AUC) | MTC Cohort | 3350 | Full Range 1040 to 6840 | ng·h/mL | |
| Change From Baseline in Free Thyroxine (T4) | MTC Cohort | Cycle 1 Day 15 | -3.80 | pmol/L | |
| Change From Baseline in Free Thyroxine (T4) | DTC Cohort | Cycle 2 Day 1 | -0.46 | Standard Deviation 5.149 | pmol/L |
| Change From Baseline in Free Thyroxine (T4) | MTC Cohort | Cycle 2 Day 1 | -0.86 | Standard Deviation 3.913 | pmol/L |
| Change From Baseline in Free Thyroxine (T4) | DTC Cohort | Cycle 3 Day 1 | -0.92 | Standard Deviation 4.985 | pmol/L |
| Change From Baseline in Free Thyroxine (T4) | MTC Cohort | Cycle 3 Day 1 | -1.00 | Standard Deviation 4.028 | pmol/L |
| Change From Baseline in Free Thyroxine (T4) | DTC Cohort | Cycle 4 Day 1 | -1.05 | Standard Deviation 5.581 | pmol/L |
1 to 10 of 231Source ClinicalTrials.gov
See all 231 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | DTC Cohort | 58 | |
| Overall Study | STARTED | MTC Cohort | 59 | |
| Overall Study | COMPLETED | DTC Cohort | 58 | |
| Overall Study | COMPLETED | MTC Cohort | 59 | |
| Overall Study | NOT COMPLETED | DTC Cohort | 0 | |
| Overall Study | NOT COMPLETED | MTC Cohort | 0 |
Source ClinicalTrials.gov
Adverse events640
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 | Lymphopenia | Blood and lymphatic system disorders | DTC Cohort | 2 | 58 | 3 |
| other | Lymphopenia | Blood and lymphatic system disorders | MTC Cohort | 6 | 59 | 6 |
| other | Neutropenia | Blood and lymphatic system disorders | DTC Cohort | 5 | 58 | 7 |
| other | Neutropenia | Blood and lymphatic system disorders | MTC Cohort | 2 | 59 | 3 |
| other | Thrombocytopenia | Blood and lymphatic system disorders | DTC Cohort | 2 | 58 | 3 |
| other | Thrombocytopenia | Blood and lymphatic system disorders | MTC Cohort | 5 | 59 | 8 |
| other | Bradycardia | Cardiac disorders | DTC Cohort | 5 | 58 | 6 |
| other | Bradycardia | Cardiac disorders | MTC Cohort | 0 | 59 | 0 |
| other | Tachycardia | Cardiac disorders | DTC Cohort | 7 | 58 | 7 |
| other | Tachycardia | Cardiac disorders | MTC Cohort | 7 | 59 | 9 |
1 to 10 of 640Source ClinicalTrials.gov
See all 640 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | DTC Cohort | 44 | 58 |
| Total, all-cause mortality | MTC Cohort | 37 | 59 |
| Total, other adverse events | DTC Cohort | 58 | 58 |
| Total, other adverse events | MTC Cohort | 59 | 59 |
| Total, serious adverse events | DTC Cohort | 32 | 58 |
| Total, serious adverse events | MTC Cohort | 42 | 59 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 |
|---|---|
| DTC Cohort vs MTC Cohort: deaths from any cause | Trial comparisons |
| DTC Cohort vs MTC Cohort: 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/NCT00784303
GET https://conductscience.org/api/trials/v1/NCT00784303/results?page=2