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Anaplastic Thyroid CancerPhase 2HOPENCT02726503

Phase II Study Assessing the Efficacy and Safety of Lenvatinib for Anaplastic Thyroid Cancer

A Phase 2 study testing Lenvatinib in people with Anaplastic Thyroid Cancer, run by Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan at 23 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

The purpose of this phase Ⅱ study is to assess the efficacy and safety of lenvatinib for anaplastic thyroid cancer patients who are diagnosed as unresectable. The total duration of the study will be 30 months. Read more about this study

Who is it for?
Ages 20 years and older
Conditions the study is for
Anaplastic Thyroid Cancer
What is being tested?
Lenvatinib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
39 participants
Where
23 sitesJapan
Study dates
4 Apr 2016to 20 Mar 2020
Phase
Phase 2
Are there results?
None posted in the registry

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 confirmed as anaplastic thyroid cancer
  • Unresectable disease
  • Have measurable lesion defined by the RECIST version 1.1
  • Have adequate organ function and meet following laboratory value:
  • Bone marrow function test within 14 days prior to enrollment:
  • neutrophil count>=1.5 x 103/microL blood platelet count>=10.0 x 104/microL hemoglobin amount>=9.0 g/dL
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  • Liver function test within 14 days prior to enrollment:
  • AST,ALT<=3.0 x ULN(without liver metastatic) AST,ALT<=5.0 x ULN(with liver metastatic) bilirubin<=2.0 mg/dL
  • Kidney function test within 14 days prior to enrollment:
  • GFR estimation>=50 ml/min/1.73 m2 GFR estimation calculated by following formula. Male:194 x(serum creatinine concentration)-1.094 x(Age)-0.287 Female:Male GFR estimation x 0.739
  • Cardiac function test within 28 days prior to enrollment: 12-lead electrocardiogram: no clinically important abnormality as shown below: heart disease, severe arrhythmia etc.
  • Regardless of usage of antihypertensive drug, systolic blood pressure <=140 mm Hg and diastolic blood pressure <=90 mm Hg (If already taking antihypertensive drug, must have capacity of further antihypertensive therapy.)
  • ECOG performance status 0-2
  • Ability to swallow oral medications
  • Life expectancy greater than 8 weeks
  • Have signed written informed consent to participate in this study

Who cannot join

  • Have complications or medical history of
  • Complication of brain metastasis (Exclude if cured and in clinically stable condition for more than 1 month prior to screening.)
  • Treatment required complication of systemic infectious disease
  • Complication of pulmonary fibrosis or interstitial pneumonitis
  • Medical history of clinically significant cardiovascular disease within 6 months of initial dose as: NYHA class above 2 leveled congestive heart failure, unstable angina, cardiac infarction or cardiac arrhythmia with paroxysmal or required treatment e) Uncontrollable complication of diabetes mellitus f) hemoptysis within 3 weeks of enrollment (blood volume of more than half of teaspoon) g) Medical history of hemorrhagic or thrombotic disease within 6 months of enrollment h) If proteinuria values above 2+ by urinary protein qualitative test, conduct 24-hour urine collection and the urine protein determined as 1g/24 hours or more. (can substitute to the ratio of proteinuria in morning urine/creatinine) i) Malabsorption at gastrointestinal tract and any of the complication diseases that investigator considers that will be affected to lenvatinib absorption j) Recent major surgery within 2 weeks (if needle biopsy within 1 week) of enrollment k) Drainage required celomic fluid stagnation
  • Have history of lenvatinib administration
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  • Confirmed tumor invasion to the carotid arteries
  • Have history of high dose external radiation therapy to cervical region, and irradiated tumor location close to the carotid arteries.
  • Have any unresolved toxicity greater than 1 by CTCAE v4.0.
  • Have active double cancer
  • Female patients who are pregnant, lactating, breast feeding or have childbearing potential
  • Psychiatric disorder and regarded by the investigator as inadequate for this study enrollment
  • Confirmed as no resistance to any component of this drug
  • Currently receiving other interventional clinical study treatment

Trial locations and contacts

23 sites in 1 country.

23 sites in 1 country

Japan23 sites

  • Nippon Medical School Hospital

    Bunkyo-ku, Tokyo, 113-8603

  • IUHW Ichikawa Hospital

    Ichikawa, Chiba, 272-0827

  • Nara Hospital Kinki University Faculty of Medicine

    Ikoma, Nara, 630-0293

  • Nara Medical University

    Kashihara, Nara, 634-8522

  • National Cancer Center Hospital East

    Kashiwa, Chiba, 277-8577

  • Kuma Hospital

    Kobe, Hyōgo, 650-0011

  • Kobe Univbersity Hospital

    Kobe, Hyōgo, 650-0017

  • The Cancer Institute Hospital of JFCR

    Koto-ku, Tokyo, 135-8550

  • Shinsyu University School of Medicine Department of Surgery

    Matsumoto, Nagano, 390-8621

  • Iwate Medical University Hospital

    Morioka, Iwate, 020-8505

  • Nagoya University Hospital

    Nagoya, Aichi-ken, 466-8560

  • Japanese Red Cross Narita Hospital

    Narita, Chiba, 286-8523

  • Miyaghi Cancer Center

    Natori-shi, Miyagi, 981-1293

  • Osaka Police Hospital

    Osaka, Osaka, 543-0035

  • Osaka City University Graduate School of Medicine and Faculty of Medicine

    Osaka, Osaka, 545-8585

  • Kitasato University Hospital

    Sagamihara, Kanagawa, 252-0375

  • Tohoku University Hospital

    Sendai, Miyagi, 980-8574

  • Ito Hospital

    Shibuya-ku, Tokyo, 150-8308

  • Tokyo Medical University Hospital

    Shinjuku-ku, Tokyo, 160-0023

  • Fujita Health University Hospital

    Toyoake, Aichi-ken, 470-1192

  • University of Tsukuba Hospital

    Tsukuba, Ibaraki, 305-8576

  • Showa University Northern Yokohama Hospital

    Yokohama, Kanagawa, 224-8503

  • Kanagawa Cancer Center

    Yokohama, Kanagawa, 241-8515

Other trials in Japan

About this study

Official title: Phase II Study Assessing the Efficacy and Safety of Lenvatinib for Anaplastic Thyroid Cancer (HOPE)

The purpose of this phase Ⅱ study is to assess the efficacy and safety of lenvatinib for anaplastic thyroid cancer patients who are diagnosed as unresectable. The total duration of the study will be 30 months. All patients will start administration of lenvatinib within 1 week of enrollment and receive the study drug 24mg orally once daily at almost the same time. 1 cycle consists of 4 weeks. Treatment term starts on the day 1st of drug administration of cycle 1 and administration will be continued until patients meet withdrawal criteria. Safety and efficacy assesment will be conducted on a regular basis during the trial. Tumor evaluation will be conducted at 4weeks, 8 weeks, 12 weeks, 16 weeks and at every 8 weeks after the 16th week since initial administration. When study drug administration terminated,tests of the drug termination will be conducted within 7 days of withdrawal and final observation will be conducted at 30 days after the last dose. Survival survey will be conducted at follow-up term. After the termination of the study drug, survival follow up survey will be conducted every 12 weeks unless patients withdraw enrollment of this study.

Being tested
Lenvatinib
Keywords
anaplastic thyroid cancer, lenvatinib
Medical subject headings
Thyroid Carcinoma, Anaplastic

What participants receive

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

  • LenvatinibDrug

    All patients will receive lenvatinib 24 mg orally once daily at almost the same time. The treatment will be started within 1 week after enrollment. 1 cycle consists of 4 weeks.

    The administration will be continued until patients meet withdrawal criteria. If any toxicity manifested that cannot be ruled out causal association with the study drug, drug withdrawal or dosage reduction will be conducted in accordance with drug withdrawal/dosage reduction criteria.

Study groups in NCT02726503
Study groupRoleWhat they receive
Treatment ArmExperimentalNot described
Receives: Drug: Lenvatinib

What is being measured

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

  1. Overall Survival (OS)

    OS is defined as time frame from date of initial dose until date of death from any cause. Or until the last confirmed survival date, study cut-off date which ever comes first.

    Measured: up to 30 months

Secondary outcomes (6)

  1. Progression-Free Survival (PFS)

    PFS is defined as time frame from date of initial dose until the date of first confirmed disease progression, until date of death from any cause or the last tumor evaluating date whichever comes first.

    Measured: up to 30 months

  2. Best Overall Response (BOR)

    BOR is defined as the best total efficacy record during the date of initial dose to the date of study completion, by which evaluated with following index. Complete Response (CR), Partial Response (PR), Stable Disease (SD is defined as ≧3 weeks),Pharmacodynamics/Progressive Disease (PD) or Not Evaluable (NE).

    Measured: up to 30 months

  3. Objective Response Rate (ORR)

    ORR is defined as the ratio of patients who are evaluated as CR or PR in Best Overall Response (BOR).

    Measured: up to 30 months

  4. Disease Control Rate (DCR)

    DCR is defined as the ratio of patients who are evaluated as CR, PR or SD in Best Overall Response (BOR).

    Measured: up to 30 months

  5. Clinical Benefit Rate (CBR)

    CBR is defined as the ratio of patients who are evaluated as CR, PR or durable SD (dSD is defined as ≧11 weeks SD) in Best Overall Response (BOR).

    Measured: up to 30 months

  6. Safety assessment on the incidence ratio of adverse events

    Safety assessment will be assessed by the ratio of adverse event

    Measured: up to 30 months

Timeline

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

  1. First posted1 Apr 2016 (estimated)
  2. Study start4 Apr 2016
  3. Primary completion25 Feb 2020
  4. Study completion20 Mar 2020

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
39 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02726503
Sponsor's protocol ID
TRIHN1504
Other IDs
UMIN000020773
Acronym
HOPE
Status last verified
Jun 2020
First submitted
29 Mar 2016
Last updated
17 Jun 2020
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Lenvatinib in people with Anaplastic Thyroid Cancer, run by Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan at 23 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 16 inclusion and 14 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 17 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 23 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Overall Survival (OS) (time frame: up to 30 months). 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 NCT02726503.

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 17 Jun 2020.

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