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Refractory CancerPhase 2NCT03199677

A Clinical Study of Apatinib in Patients With Local Progressive/Metastatic Refractory Thyroid Cancer

A Phase 2 study testing Apatinib in people with Refractory Cancer, run by Chinese Academy of Medical Sciences 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 The sponsor has not verified this record for over two years, so it may be out of date.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 single-center, open-label, single arm，exploratory clinical trial evaluating the efficacy and safety of Apatinib in patients with local progressive/metastatic refractory thyroid cancer. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Refractory Cancer
What is being tested?
Apatinib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteChina
Study dates
1 Jul 2017to 30 Jun 2018
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

  • ≥18 years old，gender limitation.
  • The pathologic subtype of thyroid carcinoma, which was confirmed by histopathological histology, included iodine refractory thyroid papillary carcinoma and follicular carcinoma, medullary thyroid carcinoma and undifferentiated carcinoma.
  • Patients with at least one measurable lesion (RECIST1.1), at least one measurable lesion after the treatment (spiral CT scan length to diameter 10 mm or higher, according with the requirement of RESCIST version 1.1 standard).
  • Radioactive iodine deficiency (according with one of the following conditions):
  • The target lesion was completely deprived of iodine in the treatment of radioactive iodine;
  • The patients were treated with single dose of iodine (3.7 GBq) and the disease progressed in 12 months;
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  • The patients were given an iodine treatment interval of less than 12 months, and the dose was greater than that 3.7 GBq [≥100mCi], with at least one iodine treatment over 12 months of disease progression;
  • Cumulative doses of radioactive iodine were greater than 22.2 GBq (or more than 600 mCi).
  • Patients who underwent at least one failure of standard chemotherapy can be recommended to get into the group.
  • Organs function have to be compliant with the following specifications:
  • ANC≥1.5×109/L; PLT≥100×109/L; Hb≥90g/L; TBIL≤1.5×ULN; ALT \&AST ≤2.5×ULN ; ALT \&AST ≤5×ULN in patients with hepatic metastasis; BUN \& Cr≤1×ULN, CCR≥50mL/min (Cockcroft-Gault formula); Normal coagulation function (INR<1.5 or PT<ULN+4s or APTT<1.5 ULN); Urinary protein<++ or urine protein quantitation in 24 hours ≤1.0 g.
  • Life expectancy ≥ 12 weeks.
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0~2.
  • Pre-menopausal women must have a negative pregnancy test within 7 days before study entry and agree to use a medically acceptable method of contraception throughout the treatment periods and for at least six weeks after treatment discontinuation.
  • The subjects volunteered to participate in the study, sign informed consent forms, and compliance with follow-up.

Who cannot join

  • The presence of a third interstitial fluid (such as a large amount of pleural effusion and/or peritoneal fluid, pericardial fluid) that cannot be controlled by a drainage or other methods.
  • Before or at the same time with other malignant tumors, except cured skin basal cell carcinoma, cervical carcinoma in situ or other effective treatment of tumors and did not see signs of disease for five years.
  • The patients who used VEGFR-TKI drugs, such as Vandetanib， Cabozantinib， Lenvatinib，Sunitinib，Sorafenib in one month.
  • Inability to swallow, chronic diarrhea and obstruction of the intestine, various factors which affect drug use and absorption.
  • major surgical or severe trauma injuries, fractures, or ulcers before 4 weeks of enrolling , 3 weeks of radiation therapy (except for partial palliative radiation), chemotherapy, and molecular target therapy in three weeks, Treatment with nitrocarbamide or mitomycin before six weeks of enrolling.
  • uncontrolled hypertension (systolic blood pressure of 140mmHg or diastolic pressure is greater than 90mmHg, despite the best drug treatment).
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  • Patients used to suffer from severe cardiovascular diseases: Ⅱ magnitude of myocardial ischemia and myocardial infarction, poor control of cardiac arrhythmias (including QTc interphase male ≥450ms, female≥470ms); According to NYHA standard, Ⅲ ~ Ⅳ cardiac insufficiency, or heart color indicate left ventricular ejection fraction (LVEF) < 50%.
  • History of significant hemoptysis within 2 months prior to enrollment or daily hemoptysis is up to 2.5ml;with the trend of haemorrhage or prior treatment with an angiogenesis therapy.
  • Significant clinical significance of bleeding symptoms or a definite bleeding tendency happened in three months prior to screening, such as gastrointestinal bleeding, bleeding ulcers, baseline period + + and above of defecate occult blood, or those with vasculitis, etc.
  • Active brain metastasis, cancer meningitis, Spinal cord oppressor activity of brain metastases of, cancer, spinal cord compression patients, CT or MRI examination revealed brain or soft meningeal disease (patients who completed treatment and get stable symptoms with brain metastases can be into the group in 21 days prior to screening, without symptoms of cerebral hemorrhage).
  • Imaging (CT or MRI) showed that tumor lesions were less than 5mm from the large blood vessels, or the central type of tumor that had penetrated the large blood vessels, or there is a clear pulmonary void or necrotic tumor.
  • Patients accept other anti-tumor therapies at the same time.
  • Treatment of thyroid cancer radiation was received 28 days prior to screening.
  • Participated in other clinical trials within 4 weeks.
  • Active or chronic hepatitis c and/or hepatitis b infection and other active infections (determined by the investigators).
  • History of immunodeficiency disease, including human immunodeficiency virus infect(HIV), or acquired immunodeficiency disease (AID) and Congenital immunodeficiency disease, or history of organs for transplantation.
  • Abdominal fistula, digestive tract perforation or intra-abdominal abscess happened within six months prior to screening.
  • Within 12 months before the first treatment occurs artery / venous thromboembolic events, such as cerebral vascular accident (including transient ischemic attack (TIA), hematencephalon, cerebral infarction), deep vein thrombosis and pulmonary embolism, etc. Received a powerful CYP3A4 inhibitor treatment in the first 7 days before the group, or received a powerful CYP3A4 inducer in the first 12 days before the study.
  • According to the investigator's judgment, there is serious illness to endanger the safety of patients, the completion of the study (e.g: severe diabetes, renal insufficiency).
  • A history of specific neurological or psychiatric disorders, including epilepsy or dementia.
  • Other cases that the investigator found ineligible.

Trial locations and contacts

1 site in 1 country.

Shengyu Zhou, professor contact

13520852899

typhoonwho@126.com

Hongzhe Wang, doctor contact

18911052235

aiesecarrow@163.com

China1 site, 1 recruiting

  • Cancer Hospital, Chinese Academy of Medical Sciences

    Beijing, Beijing Municipality, 100021

    Dawei Wu, professor, 13521689314, cancergcp@163.com

    Shengyu Zhou, professor

    Recruiting

Other trials in China

About this study

Official title: An Exploratory Single-center, Open-label , Clinical Study of Apatinib in Patients With Local Progressive/Metastatic Refractory Thyroid Cancer

This is a single-center, open-label, single arm，exploratory clinical trial evaluating the efficacy and safety of Apatinib in patients with local progressive/metastatic refractory thyroid cancer.

Read the detailed description

This is a single-center, open-label, single arm，exploratory clinical trial evaluating the efficacy and safety of Apatinib in patients with local progressive/metastatic refractory thyroid cancer.

The primary endpoint is objective response rate(ORR),the secondary endpoints include progression-free-survival(PFS)；disease control rate(DCR);serum Tg、TgAb、calcitonin；safety.

If any case happens as following,including withdrawing informed consent form(ICF)、unbearable toxicity or adverse reactions、other conditions which investigators think the patients are unsuitable to go on trail,the patient will not go on trial any longer,or every subject will obtain study treatment until tumor progress with CT/MRI proof.The indicators of efficacy and safety will be always observed during the trail process.

Being tested
Apatinib
Keywords
apatinib,refractory thyroid cancer
Medical subject headings
Neoplasms, Thyroid Neoplasms

What participants receive

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

  • ApatinibDrug

    Apatinib is an oral tyrosine kinase inhibitor.

Study groups in NCT03199677
Study groupRoleWhat they receive
apatinib with 500mg qd poExperimentalPatients administrate apatinib with the dose of 500mg once per day,half an hour after a meal.
Receives: Drug: Apatinib

What is being measured

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

  1. objective response rate

    ORR is defined as the percentage of subjects having achieved confirmed Complete Response+Partial Response as best overall response according to Response Evaluation Criteria Solid Tumors(RECIST 1.1).

    Measured: 1 year

Secondary outcomes (4)

  1. progression-free-survival(PFS)

    From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months.

    Measured: 1 year

  2. disease control rate(DCR)

    Investigators will assess treatment response according to Response Evaluation Criteria in Solid Tumors 1.1（RECIST1.1）.

    Measured: 1 year

  3. serum Tg、TgAb、calcitonin

    Evaluating the change of serum level of Tg，TgAb or calcitonin,assessed up to 12 months.

    Measured: 1 year

  4. Adverse Events(AEs)

    Number of participants with treatment-related adverse events as assessed by CTCAE v4.0.

    Measured: 1 year

Timeline

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

  1. First posted27 Jun 2017
  2. Study start1 Jul 2017 (estimated)
  3. Primary completion30 Jun 2018 (estimated)
  4. Study completion30 Jun 2018 (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
Model description
single group,apatinib 500mg po qd,d1-28
Masking
None (open label)
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03199677
Sponsor's protocol ID
AHEAD-RTC001
Status last verified
Jun 2017
First submitted
16 Jun 2017
Last updated
2 Jul 2017
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Apatinib in people with Refractory Cancer, run by Chinese Academy of Medical Sciences 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 15 inclusion and 21 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 2 Jul 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 Shengyu Zhou, professor (13520852899, typhoonwho@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

objective response rate (time frame: 1 year). 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 NCT03199677.

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 2 Jul 2017.

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