Trial · NCT01728623
A Study of E7080 in Subjects With Advanced Thyroid Cancer
NCT01728623, Phase 2, Completed, Eisai Co., Ltd.; results first posted 2020-08-14
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. A Study of E7080 in Subjects With Advanced Thyroid Cancer. Trials, record NCT01728623. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01728623
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of E7080 in Subjects With Advanced Thyroid Cancer
- NCT number
- NCT01728623
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 51 participants, actual
- Lead sponsor
- Eisai Co., Ltd.
- Conditions
- Thyroid Cancer
- Interventions
- E7080 capsule
- First posted
- 2012-11-20
- Last updated
- 2020-08-14
- Results first posted
- 2020-08-14
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) | Screening visit to 30 days after the last dose of study drug, or assessed up to 3 years | Only TEAEs are included in the summary. For detailed list of adverse events (AEs), see the AE section. For each participant, only one TEAE in the same category was counted and for multiple TEAEs with different Common Terminology Criteria for Adverse Events version 4.0 (CTCAE v 4.0) grades, only the event with the highest grade was reported. All AEs were graded using CTCAE v 4.0, except for alopecia and infertility. |
| Secondary | Progression-free Survival (PFS) | From first date of study treatment until progression of disease or date of death from any cause, whichever comes first, assessed up to 34 months | PFS was defined as the time from (1) the date of randomization to the date of first documentation of disease progression based on Investigator and Independent Review Committee assessments according to Response Evaluation Criteria In Solid Tumors version 1.1 (RECIST v1.1), or (2) death, whichever came first. Disease progression for the MTC group was measured using computed tomography (CT) or magnetic resonance imaging (MRI) on targeted tumors. Disease progression per RECIST v1.1 was defined as at least a 20 percent (%) relative increase and 5 millimeter (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. Summarized by the Kaplan-Meier method using median time with 95% confidence interval (CI). |
| Secondary | Overall Survival (OS) | From study start until date of death from any cause, assessed up to 34 months | OS was defined as the time from the date of first dose of study treatment to the date of death from any cause. If death was not observed for a participant, the survival time was censored at the date the participant was last known alive or the data cutoff date (whichever occurred first). Summarized by the Kaplan-Meier method using median time with 95% CI. |
| Secondary | Best Overall Response (BOR) | Date of first dose of study treatment to CR, PR, SD, PD, or NE, assessed up to 34 months | BOR was defined as the best response observed between the time of first dose and the study completion, assessed by either of complete response (CR), partial response (PR), stable disease (SD), progressive disease (PD), or not evaluable (NE). Tumor assessment was performed by the investigator using RECIST 1.1. The CR and PR were determined only when these responses met each criterion even after 28 days from the time observed. CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) had to have reduction in short axis to less than 10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. SD was defined as greater than or equal to 7 weeks for DTC and MTC, greater than or equal to 3 weeks for ATC. |
| Secondary | Objective Response Rate (ORR) | Date of CR or PR to date of PD or death (whichever was first), assessed up to 34 months | ORR was defined as the percentage of participants who had BOR of CR or PR. Tumor assessment was performed by the investigator using RECIST 1.1. ORR based on the investigator assessment was provided with a corresponding exact 95% CI which was calculated using exact method of binomial distribution. |
| Secondary | Disease Control Rate (DCR) | Date of CR, PR, or SD to date of PD or death (whichever was first), assessed up to 34 months | The DCR was defined as the percentage of participants who had BOR of CR, PR, or SD. Tumor assessment was performed by the investigator using RECIST 1.1. DCR based on the investigator assessment was provided with a corresponding exact 95% CI which was calculated using exact method of binomial distribution. |
| Secondary | Clinical Benefit Rate (CBR) | Date of CR, PR, or dSD to date of PD or death (whichever was first), assessed up to 34 months | The CBR was defined as the percentage of participants who had BOR of CR, PR, or durable SD (dSD). Tumor assessment was performed by the investigator using RECIST 1.1. Durable stable disease was defined as SD lasting greater than or equal to 23 weeks for DTC and MTC, greater than or equal to 11 weeks for ATC. A 95% CI was calculated using exact method of binomial distribution. |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) | Screening visit to 30 days after the last dose of study drug, or assessed up to 3 years | Safety population included all participants who received at least one dose of study drug and had at least one postbaseline safety evaluation. | Percentage of participants | NUMBER |
| SECONDARY | Progression-free Survival (PFS) | From first date of study treatment until progression of disease or date of death from any cause, whichever comes first, assessed up to 34 months | Full analysis set included all participants who received at least one dose of study drug. | Months | MEDIAN |
| SECONDARY | Overall Survival (OS) | From study start until date of death from any cause, assessed up to 34 months | Full analysis set included all participants who received at least one dose of study drug. | Months | MEDIAN |
| SECONDARY | Best Overall Response (BOR) | Date of first dose of study treatment to CR, PR, SD, PD, or NE, assessed up to 34 months | Full analysis set included all participants who received at least one dose of study drug. | Percentage of participants | NUMBER |
| SECONDARY | Objective Response Rate (ORR) | Date of CR or PR to date of PD or death (whichever was first), assessed up to 34 months | Full analysis set included all participants who received at least one dose of study drug. | Percentage of participants | NUMBER |
| SECONDARY | Disease Control Rate (DCR) | Date of CR, PR, or SD to date of PD or death (whichever was first), assessed up to 34 months | Full analysis set included all participants who received at least one dose of study drug. | Percentage of participants | NUMBER |
| SECONDARY | Clinical Benefit Rate (CBR) | Date of CR, PR, or dSD to date of PD or death (whichever was first), assessed up to 34 months | Full analysis set included all participants who received at least one dose of study drug. | Percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group36
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) | Arm 4: Lenvatinib (DTC, MTC, ATC) | TEAEs | 100.0 | Percentage of participants | |
| Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) | Arm 4: Lenvatinib (DTC, MTC, ATC) | CTCAE Grade 3 or 4 TEAEs | 82.4 | Percentage of participants | |
| Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) | Arm 4: Lenvatinib (DTC, MTC, ATC) | Serious TEAEs | 52.9 | Percentage of participants | |
| Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) | Arm 4: Lenvatinib (DTC, MTC, ATC) | TEAEs leading to study drug withdrawal | 2.0 | Percentage of participants | |
| Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) | Arm 4: Lenvatinib (DTC, MTC, ATC) | TEAEs leading to study drug reduction | 96.1 | Percentage of participants | |
| Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) | Arm 4: Lenvatinib (DTC, MTC, ATC) | TEAEs leading to study drug interruption | 66.7 | Percentage of participants | |
| Progression-free Survival (PFS) | Lenvatinib (Arm 1) | 25.8 | 95% Confidence Interval 18.4 to NA | Months | |
| Progression-free Survival (PFS) | Lenvatinib (Arm 2) | 9.2 | 95% Confidence Interval 1.8 to NA | Months | |
| Progression-free Survival (PFS) | Lenvatinib (Arm 3) | 7.4 | 95% Confidence Interval 1.7 to 12.9 | Months | |
| Overall Survival (OS) | Lenvatinib (Arm 1) | 31.8 | 95% Confidence Interval 31.8 to NA | Months |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Arm 4: Lenvatinib (MTC, DTC, ATC) | 51 | |
| Overall Study | DTC | Arm 4: Lenvatinib (MTC, DTC, ATC) | 25 | |
| Overall Study | MTC | Arm 4: Lenvatinib (MTC, DTC, ATC) | 9 | |
| Overall Study | ATC | Arm 4: Lenvatinib (MTC, DTC, ATC) | 17 | |
| Overall Study | COMPLETED | Arm 4: Lenvatinib (MTC, DTC, ATC) | 23 | |
| Overall Study | NOT COMPLETED | Arm 4: Lenvatinib (MTC, DTC, ATC) | 28 |
Source ClinicalTrials.gov
Adverse events98
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 | Arm 4: Lenvatinib (DTC, MTC, ATC) | 5 | 51 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Arm 4: Lenvatinib (DTC, MTC, ATC) | 11 | 51 | |
| other | Palpitations | Cardiac disorders | Arm 4: Lenvatinib (DTC, MTC, ATC) | 3 | 51 | |
| other | Hypothyroidism | Endocrine disorders | Arm 4: Lenvatinib (DTC, MTC, ATC) | 7 | 51 | |
| other | Abdominal distention | Gastrointestinal disorders | Arm 4: Lenvatinib (DTC, MTC, ATC) | 4 | 51 | |
| other | Abdominal pain | Gastrointestinal disorders | Arm 4: Lenvatinib (DTC, MTC, ATC) | 4 | 51 | |
| other | Abdominal pain upper | Gastrointestinal disorders | Arm 4: Lenvatinib (DTC, MTC, ATC) | 12 | 51 | |
| other | Cheilitis | Gastrointestinal disorders | Arm 4: Lenvatinib (DTC, MTC, ATC) | 3 | 51 | |
| other | Constipation | Gastrointestinal disorders | Arm 4: Lenvatinib (DTC, MTC, ATC) | 13 | 51 | |
| other | Dental caries | Gastrointestinal disorders | Arm 4: Lenvatinib (DTC, MTC, ATC) | 3 | 51 |
1 to 10 of 98Source ClinicalTrials.gov
See all 98 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Arm 4: Lenvatinib (DTC, MTC, ATC) | 4 | 51 |
| Total, other adverse events | Arm 4: Lenvatinib (DTC, MTC, ATC) | 51 | 51 |
| Total, serious adverse events | Arm 4: Lenvatinib (DTC, MTC, ATC) | 27 | 51 |
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT01728623
GET https://conductscience.org/api/trials/v1/NCT01728623/results?page=2