Back to resultsA Study of E7080 in Subjects With Advanced Thyroid Cancer
Primary Purpose
Thyroid Cancer
Status
Completed
Phase
Phase 2
Locations
Japan
Study Type
Interventional
Intervention
E7080 capsule
Sponsored by
About this trial
This is an interventional treatment trial for Thyroid Cancer focused on measuring Thyroid cancer
Eligibility Criteria
Inclusion criteria
- Histologically or clinically diagnosed with thyroid cancer
- Eastern Cooperative Oncology Group Performance Status (ECOG-PS) 0-2
- Adequate laboratory values/organ function tests
Exclusion criteria
Participants with following complication or disease history
- Brain metastasis
- Systemic severe infection
- Significant cardiovascular impairment
- QTc greater than 480 milliseconds
- Active hemoptysis
- Bleeding or thrombotic disorders
- Having greater than 1+ proteinuria on urine dipstick testing will undergo 24 hour urine collection for quantitative assessment of proteinuria
- Gastrointestinal malabsorption or any other condition in the opinion of the investigator that might affect the absorption of E7080
- Major surgery within 3 weeks before enrollment
- With co-existing effusion requiring drainage
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
E7080
Arm Description
Outcomes
Primary Outcome Measures
Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs)
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 Outcome Measures
Progression-free Survival (PFS)
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).
Overall Survival (OS)
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.
Best Overall Response (BOR)
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.
Objective Response Rate (ORR)
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.
Disease Control Rate (DCR)
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.
Clinical Benefit Rate (CBR)
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01728623
Brief Title
A Study of E7080 in Subjects With Advanced Thyroid Cancer
Official Title
A Phase 2 Study of E7080 in Subjects With Advanced Thyroid Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
September 3, 2012 (Actual)
Primary Completion Date
July 9, 2015 (Actual)
Study Completion Date
October 1, 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eisai Co., Ltd.
4. Oversight
5. Study Description
Brief Summary
This study is to evaluate the safety, efficacy, and pharmacokinetics of E7080 when orally administered once daily (QD) in subjects with advanced thyroid cancer.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thyroid Cancer
Keywords
Thyroid cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
51 (Actual)
8. Arms, Groups, and Interventions
Arm Title
E7080
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
E7080 capsule
Intervention Description
E7080 is administered as continuous once daily dosing in an uncontrolled manner
Primary Outcome Measure Information:
Title
Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs)
Description
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.
Time Frame
Screening visit to 30 days after the last dose of study drug, or assessed up to 3 years
Secondary Outcome Measure Information:
Title
Progression-free Survival (PFS)
Description
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).
Time Frame
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
Title
Overall Survival (OS)
Description
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.
Time Frame
From study start until date of death from any cause, assessed up to 34 months
Title
Best Overall Response (BOR)
Description
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.
Time Frame
Date of first dose of study treatment to CR, PR, SD, PD, or NE, assessed up to 34 months
Title
Objective Response Rate (ORR)
Description
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.
Time Frame
Date of CR or PR to date of PD or death (whichever was first), assessed up to 34 months
Title
Disease Control Rate (DCR)
Description
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.
Time Frame
Date of CR, PR, or SD to date of PD or death (whichever was first), assessed up to 34 months
Title
Clinical Benefit Rate (CBR)
Description
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.
Time Frame
Date of CR, PR, or dSD to date of PD or death (whichever was first), assessed up to 34 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria
Histologically or clinically diagnosed with thyroid cancer
Eastern Cooperative Oncology Group Performance Status (ECOG-PS) 0-2
Adequate laboratory values/organ function tests
Exclusion criteria
Participants with following complication or disease history
Brain metastasis
Systemic severe infection
Significant cardiovascular impairment
QTc greater than 480 milliseconds
Active hemoptysis
Bleeding or thrombotic disorders
Having greater than 1+ proteinuria on urine dipstick testing will undergo 24 hour urine collection for quantitative assessment of proteinuria
Gastrointestinal malabsorption or any other condition in the opinion of the investigator that might affect the absorption of E7080
Major surgery within 3 weeks before enrollment
With co-existing effusion requiring drainage
Facility Information:
City
Kashiwa
State/Province
Chiba
Country
Japan
City
Kobe
State/Province
Hyogo
Country
Japan
City
Koto-ward
State/Province
Tokyo
Country
Japan
12. IPD Sharing Statement
Citations:
PubMed Identifier
30638399
Citation
Takahashi S, Kiyota N, Yamazaki T, Chayahara N, Nakano K, Inagaki L, Toda K, Enokida T, Minami H, Imamura Y, Fukuda N, Sasaki T, Suzuki T, Ikezawa H, Dutcus CE, Tahara M. A Phase II study of the safety and efficacy of lenvatinib in patients with advanced thyroid cancer. Future Oncol. 2019 Mar;15(7):717-726. doi: 10.2217/fon-2018-0557. Epub 2019 Jan 14.
Results Reference
derived
PubMed Identifier
28299283
Citation
Tahara M, Kiyota N, Yamazaki T, Chayahara N, Nakano K, Inagaki L, Toda K, Enokida T, Minami H, Imamura Y, Sasaki T, Suzuki T, Fujino K, Dutcus CE, Takahashi S. Lenvatinib for Anaplastic Thyroid Cancer. Front Oncol. 2017 Mar 1;7:25. doi: 10.3389/fonc.2017.00025. eCollection 2017.
Results Reference
derived
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A Study of E7080 in Subjects With Advanced Thyroid Cancer
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