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Thyroid CancerPhase 2NCT01728623

A Study of E7080 in Subjects With Advanced Thyroid Cancer

A Phase 2 study testing E7080 capsule in people with Thyroid Cancer, run by Eisai Co., Ltd. at 3 sites in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 20 years and older
Conditions the study is for
Thyroid Cancer
What is being tested?
E7080 capsule
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
51 participants
Where
3 sitesJapan
Study dates
3 Sep 2012to 1 Oct 2015
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • Participants with following complication or disease history
  • Brain metastasis
  • Systemic severe infection
  • Significant cardiovascular impairment
  • QTc greater than 480 milliseconds
  • Active hemoptysis
Show all 11Show fewer
  • 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

Trial locations and contacts

3 sites in 1 country.

Japan3 sites

  • Study site

    Kashiwa, Chiba

  • Study site

    Kobe, Hyōgo

  • Study site

    Koto-ward, Tokyo

Other trials in Japan

About this study

Official title: A Phase 2 Study of E7080 in Subjects With Advanced Thyroid Cancer

This study is to evaluate the safety, efficacy, and pharmacokinetics of E7080 when orally administered once daily (QD) in subjects with advanced thyroid cancer.

Conditions
Thyroid Cancer
Being tested
E7080 capsule
Keywords
Thyroid cancer
Medical subject headings
Thyroid Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • E7080 capsuleDrug

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

Study groups in NCT01728623
Study groupRoleWhat they receive
E7080ExperimentalNot described
Receives: Drug: E7080 capsule

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

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

Secondary outcomes (6)

  1. 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).

    Measured: 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

  2. 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.

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

  3. 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.

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

  4. 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.

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

  5. 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.

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

  6. 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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Nov 2012 (estimated)
  2. Study start3 Sep 2012
  3. Primary completion9 Jul 2015
  4. Study completion1 Oct 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
51 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01728623
Sponsor's protocol ID
E7080-J081-208
Status last verified
Jul 2020
First submitted
7 Sep 2012
Last updated
14 Aug 2020

Publications

  • 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.

    PubMed 30638399

  • 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.

    PubMed 28299283

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing E7080 capsule in people with Thyroid Cancer, run by Eisai Co., Ltd. at 3 sites in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 14 Aug 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) (time frame: Screening visit to 30 days after the last dose of study drug, or assessed up to 3 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01728623, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2020.

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