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Differentiated Thyroid CancerPhase 2/3NCT02586337

Study of Anlotinib in Patients With Differentiated Thyroid Cancer(ALTER01032)

A Phase 2/3 study testing Anlotinib in people with Differentiated Thyroid Cancer, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 19 sites in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The purpose of this study is to compare the effects and safety of Anlotinib with placebo in patients with Differentiated Thyroid Cancer. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Differentiated Thyroid Cancer
What is being tested?
Anlotinib
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
113 participants
Where
19 sitesChina
Study dates
Jul 2015to Dec 2019
Phase
Phase 2/3
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 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Signed and dated informed consent
  • Histological documentation of Differentiated Thyroid Cancer ,With measurable disease (using RECIST1.1)
  • ECOG PS:0-1,Life expectancy of more than 6 months
  • Subjects must be 131I-refractory / resistant as defined by at least one of the following:
  • Lesions that do not demonstrate iodine uptake on any radioiodine scan
  • Cumulative activity of 131I of >600 mCi or 22 gigabequerels (GBq)
  • Lesion that demonstrate iodine uptake on any radioiodine scan,but has progressed by RECIST 1.1 within 18 months of 131I therapy
  • main organs function is normal

Who cannot join

  • Prior treatment with Anlotinib or VEGFR-targeted therapies(such as Vandetanib,Cabozantinib,Lenvatinib,Sunitinib,Sorafenib etc.)
  • Subjects received radiotherapy external exposure or 131I within 3 months prior to the first dose of study drug or plan to be received any anti-cancer treatment during study
  • Patients suffering from other malignancies currently or within 5 years, except for cured cervical carcinoma in situ, non-melanoma skin cancers and superficial bladder cancer [ Ta (non-invasive carcinoma), Tis (carcinoma in situ) and T1 (carcinoma invasion into lamina propria) ]
  • CTCAE(4.0) Grade 1 or higher non-remission toxicity induced by any other previous treatments，excluding alopecia and Grade 2 or lower neurotoxicity induced by oxaliplatin
  • Patients with factors that could affect oral medication (such as dysphagia etc.)
  • Patients with pleural effusion or ascites, causing respiratory syndrome (CTCAE Grade 2 or higher dyspnea [Grade 2 dyspnea refers to Shortness of breath with a small amount of activities, affecting Instrumental activities of daily life])
  • Patients underwent major surgical treatment，open biopsy or significant traumatic injury within 28 days prior to assignment

Trial locations and contacts

19 sites in 1 country.

19 sites in 1 country

China19 sites

  • Cancer Institute and Hospital, Chinese Academy of Medical Sciences

    Beijing, Beijing Municipality, 100021

  • Beijing Tongren Hospital

    Beijing, Beijing Municipality

  • Peking Union Medical College Hospital

    Beijing, Beijing Municipality

  • Jilin Cancer Hospital

    Changchun, Jilin

  • Hunan Province Tumor Hospital

    Changsha, Hunan

  • Chongqing Cancer Hospital

    Chongqing, Chongqing Municipality, 404100

  • West China Hospital Of Sichuan University

    Chongqing, Sichuan, 400010

  • Fujian Cancer Hospital

    Fuzhou, Fujian

  • Sun Yat-Sen University Cancer Center

    Guozhou, Guangdong

  • Zhejiang Cancer Hospital

    Hangzhou, Zhejiang, 310022

  • Harbin medical university affiliated tumor hospital

    Harbin, Heilongjiang

  • The First Affiliated Hospital of Kunming Medical University

    Kunming, Yunnan

  • Gansu Province Tumor Hospital

    Lanzhou, Gansu

  • Henan Province Tumor Hospital

    Luoyan, Henan

  • Jiangsu province tumor hospital

    Nanjing, Jiangsu

  • Cancer Hospital of Fudan University

    Shanghai, Shanghai Municipality

  • Liaoning Province Tumor Hospital

    Shenyang, Liaoning

  • 20th Floor, Block C, Lake Road, Hexi District, Tianjin Medical University Cancer Institute and Hospital .

    Tianjin, Tianjin Municipality, 300600

  • Union Hospital Tongji Medical College Huazhong University of Science and Technology

    Wuhan, Hubei, 430022

Other trials in China

About this study

Official title: A Randomized, Double-blind, Placebo-controlled, Multicenter Clinical Trial to Compare the Efficacy and Safety of Anlotinib Versus Placebo in Patients With 131I-Refractory Differentiated Thyroid Cancer(ALTER01032)

The purpose of this study is to compare the effects and safety of Anlotinib with placebo in patients with Differentiated Thyroid Cancer.

Being tested
Anlotinib, Placebo

What participants receive

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

  • AnlotinibDrug

    Anlotinib p.o. qd

  • PlaceboDrug

    Placebo p.o. qd

Study groups in NCT02586337
Study groupRoleWhat they receive
AnlotinibExperimentalAnlotinib QD po and it should be continued until disease progression or intolerable toxicity or patients withdrawal of consent.Subjects with confirmation of disease progression by independent imaging review, while receiving blinded study drug may request to receive open label Anlotinib and enter the Optional Open Label Anlotinib Treatment Period of the Extension Phase. Subjects who request to receive open label Anlotinib(at the time of confirmed progression) will be informed whether they received placebo or Anlotinib during the period of blinded study drug administration. Subjects who received Anlotinib will not be eligible for the open-label phase.
Receives: Drug: Anlotinib
PlaceboPlacebo comparatorPlacebo QD po and it should be continued until disease progression or intolerable toxicity or patients withdrawal of consent.Subjects with confirmation of disease progression by independent imaging review, while receiving blinded study drug may request to receive open label Anlotinib and enter the Optional Open Label Anlotinib Treatment Period of the Extension Phase. Subjects who request to receive open label Anlotinib(at the time of confirmed progression) will be informed whether they received placebo or Anlotinib during the period of blinded study drug administration.
Receives: Drug: Placebo

What is being measured

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

  1. Progression-free Survival (PFS)

    To compare the Progression-free Survival (PFS) of subjects with Differentiated Thyroid Cancer(DTC) with Anlotinib versus Placebo.

    Measured: Date of randomization to the date of disease progression (measured every 6 weeks) or death (whichever occurs first) as determined by blinded independent imaging review(assessed up to 24 months)

Secondary outcomes (1)

  1. Overall Response Rate (ORR)

    To compare Overall Response Rate (ORR) (Complete and Partial Responses, CR and PR) of subjects treated with Anlotinib versus Placebo.

    Measured: Date of randomization to the date of disease progression (measured every 6 weeks) or death (assessed up to 24 months)

Timeline

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

  1. First posted26 Oct 2015 (estimated)
  2. Study startJul 2015
  3. Primary completionDec 2019 (estimated)
  4. Study completionDec 2019 (estimated)

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 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
113 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02586337
Sponsor's protocol ID
ALTN-01-IIDTC
Status last verified
May 2019
First submitted
22 Oct 2015
Last updated
21 May 2019
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Anlotinib in people with Differentiated Thyroid Cancer, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 19 sites in China.

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 8 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 21 May 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 19 sites in China. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined 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.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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

Are results available for this study?

Results are not available in the source record.

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?

Progression-free Survival (PFS) (time frame: Date of randomization to the date of disease progression (measured every 6 weeks) or death (whichever occurs first) as determined by blinded independent imaging review(assessed up to 24 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 NCT02586337.

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 21 May 2019.

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