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Differentiated Thyroid CarcinomaPhase 2NCT03167385

Phase 2 Trial of Apatinib Mesylate in Locally Advanced/Metastatic Differentiated Thyroid Carcinoma

A Phase 2 study testing Apatinib Mesylate in people with Differentiated Thyroid Carcinoma, run by Tianjin Medical University Cancer Institute and Hospital at 1 site 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 The sponsor has not verified this record for over two years, so it may be out of date.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

This is a non-randomized, phase II, open label study of Apatinib Mesylate in patients with with locally advanced or metastatic differentiated thyroid carcinoma (DTC). The purpose of this study is to evaluate the efficacy and safety of apatinib in patients with locally advanced or metastatic differentiated thyroid… Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Differentiated Thyroid Carcinoma
What is being tested?
Apatinib Mesylate
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteChina
Study dates
22 Mar 2017to 31 Dec 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 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Informed consent.
  • Histopathology confirmed locally advanced or metastatic differentiated thyroid carcinoma, with measurable lesions (RECIST 1.1).
  • Age:18-75 years, ECOG（Eastern Cooperative Oncology Group） Score:0-2, Expected survival period ≥ 3 months.
  • Patients with disease progression which was confirmed by imaging in 18 months, and meet any one of the following four:
  • The tumor invades important organs, and cannot be resectted completely, the remnant thyroid tissue is extensive and not suitable for further iodine treatment.
  • Lesions have no iodine affinity.
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  • The cumulative dose of RAI (radioactive iodine) ≥ 600mCi or 22GBq.
  • Patients with disease progression confirmed by radiological examination within 18 months of last RAI.
  • Patients general condition meeting the following:
  • Haemoglobin (HBG) ≥ 90 g/L, neutrophil count (ANC) ≥ 1.5×109/L, platelet count (PLT) ≥ 80×109/L, total bilirubin (TBIL)< 1.5×ULN (upper limit of normal), alanine aminotransferase (ALT) and aspartate aminotransferase (AST) < 2.5×ULN (ALT and AST < 5×ULN if have liver metastasis), SCr (serum creatinine) <1.5×ULN, left ventricular ejection fraction ≥ 50% of normal.
  • Past history of less than one kind of tyrosine kinase inhibitor.
  • Pregnancy test (serum or urine) has to be performed in woman of childbearing age within 7 days before enrolment and the test result must be negative. Patients enrolled should take appropriate contraceptive measures during the study until the 6th month post the last administration of study drug. For male participants, (previous surgical sterilization accepted), agreement to take appropriate methods of contraception during the study until the 6th month post the last administration of study drug is required.

Who cannot join

  • Patients with past apatinib treatment or have received two or more small molecular TKI (Tyrosine Kinase Inhibitor) drugs.
  • Patients accepted external beam radiation therapy or iodine - 131 therapy in recent three months, or patients plan to receive the other systemic anti-tumor treatment during the study.
  • Patient with history of another malignant disease within past 5 years, cervical carcinoma in situ, non melanoma skin cancer and superficial bladder tumor are spared.
  • Patients without unrelieved toxicity reaction above CTCAE grade, neurotoxicity and hair loss due to oxaliplatin are spared.
  • Preconditions that impair successful oral medication intake (such as inability to swallow, chronic diarrhea).
  • Patients with pleural effusion or ascites that lead to respiratory syndrome (above CTCAE grade 2).
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  • Patients with severe systemic diseases that might impair cardiac function, et al.
  • Patients accepted major surgery、incision biopsy or obvious traumatic injury in 28 days before the study.
  • Patients with physical signs or medical history of bleeding.
  • Patients with thromboembolism event in 6 months.
  • Patients with history of aneurysm.
  • Patients with epilepsy which needs medication.
  • Patients with history of psychiatric drug abuse or have a mental disorder.
  • Patients with history of disease in peripheral nervous system, muscle strength under level 3.
  • Attended other antitumor drug clinical trials or other ongoing clinical subjects within 4 weeks.
  • According to the researcher's judgment, there is other possible serious condition that endanger the safety of patients.

Trial locations and contacts

1 site in 1 country.

Ming Gao, MD contact

862223340123 ext. 3150

gaoming@tjmuch.com

Xiangqian Zheng, MD contact

862223340123 ext. 3150

xiangqian_zheng@163.com

China1 site, 1 recruiting

  • Tianjin Medical University Cancer Institute and Hospital

    Tianjin, Tianjin Municipality, 300060

    Xiangqian Zheng, MD

    Recruiting

Other trials in China

About this study

Official title: The Effectiveness and Safety of Apatinib Mesylate in Locally Advanced/Metastatic Differentiated Thyroid Carcinoma: a Phase 2 Trial.

This is a non-randomized, phase II, open label study of Apatinib Mesylate in patients with with locally advanced or metastatic differentiated thyroid carcinoma (DTC). The purpose of this study is to evaluate the efficacy and safety of apatinib in patients with locally advanced or metastatic differentiated thyroid carcinoma.

Read the detailed description

At present, multiple anti-angiogenesis drugs for thyroid cancer of clinical research are ongoing worldwide, and most of which achieved fairly good therapeutic effect. To date, sorafenib has been approved for the treatment of radioactive iodine refractory DTC. Apatinib is a highly selective VEGFR2 inhibitor that reduces the angiogenesis of tumor efficiently, and had been proven to be effective in many solid tumors. In this study, the investigators aim to further explore the efficacy and safety of apatinib in locally advanced or metastatic differentiated thyroid carcinoma.

Being tested
Apatinib Mesylate
Keywords
locally advanced differentiated thyroid carcinoma, radioiodine refractory thyroid carcinoma

What participants receive

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

  • Apatinib MesylateDrug

    Also called YN968D1

    oral intake of Apatinib Mesylate 500mg once a day until progression of diesase or severe adverse effect

Study groups in NCT03167385
Study groupRoleWhat they receive
ExperitmentalExperimentalContinuous oral intake of Apatinib Mesylate (500mg), once a day, until progression of disease or severe adverse effect.
Receives: Drug: Apatinib Mesylate

What is being measured

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

  1. disease control rate

    percentage of patients who have achieved complete response, partial response and stable disease to overall therapeutic intervention patients

    Measured: within two weeks of drug administration

Secondary outcomes (3)

  1. progression free survival

    time that passes from the day the participants received the apatinib and the date on which disease progresses or the date on which the patient dies, from any cause.

    Measured: 2 years

  2. overall survival

    percentage of patients who are alive after a certain time period after they were treated

    Measured: 2 years

  3. objective response rate

    percentage of patients who have achieved complete response and partial response to overall therapeutic intervention patients

    Measured: 2 weeks

Timeline

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

  1. First posted30 May 2017
  2. Study start22 Mar 2017
  3. Primary completion31 Jan 2019 (estimated)
  4. Study completion31 Dec 2020 (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
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03167385
Sponsor's protocol ID
AHEAD-HBT001
Status last verified
Mar 2017
First submitted
24 May 2017
Last updated
30 May 2017
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Apatinib Mesylate in people with Differentiated Thyroid Carcinoma, run by Tianjin Medical University Cancer Institute and Hospital at 1 site 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 12 inclusion and 16 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 30 May 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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. 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?

Results are not available in the source record.

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

Contact Ming Gao, MD (862223340123 ext. 3150, gaoming@tjmuch.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

disease control rate (time frame: within two weeks of drug administration). 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 NCT03167385.

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 30 May 2017.

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