Clinical trial NCT01728623: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Thyroid Cancer
Keywords: Thyroid cancer
Lead sponsor: Eisai Inc.
Sponsor class: INDUSTRY
First posted: 2012-11-20
Enrollment: 51
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion criteria

1. Histologically or clinically diagnosed with thyroid cancer
2. Eastern Cooperative Oncology Group Performance Status (ECOG-PS) 0-2
3. Adequate laboratory values/organ function tests

Exclusion criteria

Participants with following complication or disease history

1. Brain metastasis
2. Systemic severe infection
3. Significant cardiovascular impairment
4. QTc greater than 480 milliseconds
5. Active hemoptysis
6. Bleeding or thrombotic disorders
7. Having greater than 1+ proteinuria on urine dipstick testing will undergo 24 hour urine collection for quantitative assessment of proteinuria
8. Gastrointestinal malabsorption or any other condition in the opinion of the investigator that might affect the absorption of E7080
9. Major surgery within 3 weeks before enrollment
10. With co-existing effusion requiring drainage

Primary outcomes:
measure: Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs)
timeFrame: Screening visit to 30 days after the last dose of study drug, or assessed up to 3 years
Secondary outcomes:
measure: Progression-free Survival (PFS)
timeFrame: 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
measure: Overall Survival (OS)
timeFrame: From study start until date of death from any cause, assessed up to 34 months
measure: Best Overall Response (BOR)
timeFrame: Date of first dose of study treatment to CR, PR, SD, PD, or NE, assessed up to 34 months
measure: Objective Response Rate (ORR)
timeFrame: Date of CR or PR to date of PD or death (whichever was first), assessed up to 34 months
measure: Disease Control Rate (DCR)
timeFrame: Date of CR, PR, or SD to date of PD or death (whichever was first), assessed up to 34 months
measure: Clinical Benefit Rate (CBR)
timeFrame: Date of CR, PR, or dSD to date of PD or death (whichever was first), assessed up to 34 months
Other outcomes:
Locations:
city: Kashiwa
country: Japan
state: Chiba
city: Kobe
country: Japan
state: Hyogo
city: Koto-ward
country: Japan
state: Tokyo
Study officials:
References:
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.
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.