NCT01728623

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
51

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Sep 2012

Typical duration for phase_2

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 3, 2012

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

September 7, 2012

Completed
2 months until next milestone

First Posted

Study publicly available on registry

November 20, 2012

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 9, 2015

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
4.9 years until next milestone

Results Posted

Study results publicly available

August 14, 2020

Completed
Last Updated

August 14, 2020

Status Verified

July 1, 2020

Enrollment Period

2.8 years

First QC Date

September 7, 2012

Results QC Date

July 21, 2020

Last Update Submit

July 21, 2020

Conditions

Thyroid Cancer

Keywords

Thyroid cancer

Outcome Measures

Primary Outcomes (1)

  • 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.

    Screening visit to 30 days after the last dose of study drug, or assessed up to 3 years

Secondary Outcomes (6)

  • 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

  • Overall Survival (OS)

    From study start until date of death from any cause, assessed up to 34 months

  • Best Overall Response (BOR)

    Date of first dose of study treatment to CR, PR, SD, PD, or NE, assessed up to 34 months

  • Objective Response Rate (ORR)

    Date of CR or PR to date of PD or death (whichever was first), assessed up to 34 months

  • Disease Control Rate (DCR)

    Date of CR, PR, or SD to date of PD or death (whichever was first), assessed up to 34 months

  • +1 more secondary outcomes

Study Arms (1)

E7080

EXPERIMENTAL
Drug: E7080 capsule

Interventions

E7080 capsuleDRUG

E7080 is administered as continuous once daily dosing in an uncontrolled manner

E7080

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Unknown Facility

Kashiwa, Chiba, Japan

Location

Unknown Facility

Kobe, Hyōgo, Japan

Location

Unknown Facility

Koto-ward, Tokyo, Japan

Location

Related Publications (2)

  • 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.

    PMID: 30638399DERIVED

  • 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.

    PMID: 28299283DERIVED

MeSH Terms

Conditions

Thyroid Neoplasms

Interventions

lenvatinib

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck NeoplasmsEndocrine System DiseasesThyroid Diseases

Results Point of Contact

Title
Inquiry Service
Organization
Eisai Inc.
eisai-chiken_hotline@hhc.eisai.co.jp

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 7, 2012

First Posted

November 20, 2012

Study Start

September 3, 2012

Primary Completion

July 9, 2015

Study Completion

October 1, 2015

Last Updated

August 14, 2020

Results First Posted

August 14, 2020

Record last verified: 2020-07

Locations

JP(3)