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SarcomaPhase 1NCT04659733

Phase I Clinical Trial of Anlotinib in Progressive, Recurrent, and Refractory Sarcoma in Children

A Phase 1 study testing Anlotinib hydrochloride in people with Sarcoma, run by Yizhuo Zhang.

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 The sponsor has not verified this record for over two years, so it may be out of date.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 is to observe and evaluate the safety and effectiveness of anlotinib in children with progressive, recurrent, and refractory sarcoma. Pharmacokinetics was also detected. Read more about this study

Who is it for?
Ages 5 to 18 years
Conditions the study is for
Sarcoma
What is being tested?
Anlotinib hydrochloride
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
36 participants
Where
No sites listed yet
Study dates
30 Dec 2020to 30 Dec 2022
Phase
Phase 1
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 5 to 18 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • 1.5years ≤ age ≤18 years old, regardless of gender;
  • 2.ECOG performance status (PS) score: 0～1;
  • 3.The expected survival time is more than 12 weeks;
  • 4.Children with sarcoma confirmed by histopathology;
  • 5.Patients who have progressed, recurrent or refractory disease after first-line treatment (failure to obtain complete or partial remission after recent treatment);
  • 6.With measurable lesions (according to the RECIST 1.1 standard, the CT scan of tumor lesions has a long diameter ≥10mm, and the CT scan of lymph node lesions has a short diameter ≥15mm. The measurable lesions have not been treated with radiotherapy or cryotherapy);
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  • 7.The patients must recover from the acute toxic effects of all previous anticancer chemotherapy fully;
  • 8.Myelosuppressive chemotherapy: at least 21 days after the last myelosuppressive chemotherapy (If nitrosourea was used in the early stage, the interval time is 42 days);
  • 9.Experimental drugs or anti-cancer therapies other than chemotherapy: It is not allowed to use other experimental drugs within 28 days before the planned start of use, and it is necessary to fully recover from the clinically significant toxicity of the therapy;
  • 10.Hematopoietic growth factors: at least 14 days after the last administration of long-acting growth factors or 3 days after the last administration of short-acting growth factors;
  • 11.Immunotherapy: At least 42 days after completing any type of immunotherapy (except steroids), such as immune checkpoint inhibitors and tumor vaccines;
  • 12.X-ray therapy (XRT): at least 14 days after local palliative XRT (small-scale mouth); if it is another substantial bone marrow (BM) irradiation, including pre-radio-iodinated metaiodobenformin (131I-MIBG) treatment, the interval time must end at least 42 days;
  • 13.Stem cell infusion without total body irradiation (TBI): there is no evidence of active graft-versus-host disease, at least 56 days after transplantation or stem cell infusion;
  • 14.Laboratory inspections during the screening period should meet the following conditions: The absolute value of neutrophils (ANC) ≥1.5×109/L (if the bone marrow is invaded, then ANC≥1.0×109/L) Platelet (PLT) ≥75×109/L (if bone marrow invades, then PLT ≥50×109/L) Bilirubin ≤1.5 times ULN Creatinine ≤ 1.5 times ULN (calculated according to the standard Cockcroft-Gault formula) ALT/AST≤3 times ULN (if there is liver metastasis, it can be relaxed to 5 times ULN)
  • 15. During the study period, patients should be able to comply with outpatient treatment, laboratory monitoring, and necessary clinical visits;
  • 16. Parents/guardians of a child or young patients have the ability to understand, agree, and sign the research informed consent form (ICF) and applicable child consent form before initiating any program related procedures; Subjects can express consent (where applicable) with the consent of the parent/guardian.

Who cannot join

  • Patients with any of the following items will not be enrolled in this study:
  • Symptomatic brain metastases (patients with brain metastases who have completed treatment 21 days before enrollment and have stable symptoms can be enrolled, but they need to be evaluated by cranial MRI, CT, or venography to confirm that they have no symptoms of cerebral hemorrhage);
  • Imaging (CT or MRI) shows that the tumor focus is ≤ 5 mm from large blood vessels, or there is a tumor that invades local large blood vessels;
  • Patients with hypertension who are using two or more antihypertensive drugs in combination therapy;
  • Patients who suffer from the following cardiovascular diseases: Myocardial ischemia or myocardial infarction above grade II, poorly controlled arrhythmia (including QTc interval ≥450 ms for males and ≥470 ms for females); according to NYHA standards, grade III to IV cardiac insufficiency, or the heart color Doppler ultrasound examination showed that the left ventricular ejection fraction (LVEF) <50%;
  • Patients with a history of interstitial pulmonary disease or who also suffer from the interstitial pulmonary disease;
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  • Abnormal coagulation function (INR>1.5 or prothrombin time (PT)>ULN+4 seconds or APTT>1.5 ULN), have a bleeding tendency or are receiving thrombolytic or anticoagulant therapy;
  • The daily volume of hemoptysis reached two teaspoons or more before enrollment;
  • Patients who have had clinically significant bleeding symptoms or a clear bleeding tendency within 3 months before enrollment, such as gastrointestinal bleeding, hemorrhagic hemorrhoids, hemorrhagic gastric ulcer, fecal occult blood++ and above at baseline, or vascular
  • Arterial/venous thrombosis events that occurred in the 12 months before enrollment, such as cerebrovascular accidents (including temporary ischemic attacks, cerebral hemorrhage, cerebral infarction), deep vein thrombosis, and pulmonary embolism;
  • Known existing hereditary or acquired bleeding and thrombotic tendency (such as hemophilia, blood coagulation dysfunction, thrombocytopenia, hypersplenism, etc.);
  • Long-term unhealed wounds or fractures (pathological fractures caused by tumors are not counted);
  • Patients who received major surgery or suffered severe traumatic injury, fracture, or ulcer within 4 weeks of enrollment;
  • some factors significantly affect the absorption of oral drugs, such as inability to swallow, chronic diarrhea, and intestinal obstruction;
  • Abdominal fistula, gastrointestinal perforation, or abdominal abscess occurred within 6 months before enrollment;
  • Urine routine test showed urine protein ≥ ++, and confirmed 24-hour urine protein ≥ 1.0 g; Notes: Asymptomatic serous effusions can be included in the group, and symptomatic serous effusions have been actively treated symptomatically (anti-cancer drugs cannot be used for the treatment of serious effusions), and patients who are judged by the investigator can be included in the group，allow to join the group.
  • Active infections require antimicrobial treatment (for example, antibacterial drugs and antiviral drugs are required, excluding chronic hepatitis B anti-hepatitis B treatment, antifungal drug treatment);
  • Those who have a history of psychotropic drug abuse and cannot be quit or have mental disorders;
  • Participated in other anti-tumor drug clinical trials within 4 weeks before joining the group;
  • Previously or concurrently suffering from other uncured malignant tumors, except for cured skin basal cell carcinoma, cervical carcinoma in situ, and superficial bladder cancer;
  • Within 7 days before the first administration, patients used drugs or foods known to be potent inhibitors of CYP3A4, including but not limited to: atazanavir, clarithromycin, indinavir, itraconazole, ketocon Azole, nefazodone, nelfinafil, ritonavir, saquinavir, telithromycin, acetoeandomycin, voriconazole, etc.;
  • Within 12 days before the first administration, use drugs known to be strong inducers of CYP3A4, including but not limited to: carbamazepine, phenobarbital, phenytoin, rifabutin, and rifapar;
  • Pregnant or breast-feeding women; fertility patients who are unwilling or unable to take effective contraceptive measures;
  • The investigator judges other situations that may affect the conduct of clinical research and the judgment of research results.
  • When the virological test during the screening period shows that any of the following is met:
  • HBsAg is positive and HBV DNA exceeds the upper limit of normal Anti-HCV positive and HCV RNA positive HIV positive

Trial locations and contacts

No sites are listed yet.

Yizhuo Zhang contact

02087342460

zhangyzh@sysucc.org.cn

About this study

The purpose is to observe and evaluate the safety and effectiveness of anlotinib in children with progressive, recurrent, and refractory sarcoma. Pharmacokinetics was also detected.

Read the detailed description

Patients were enrolled according to the standard design of the Phase I study. Anlotinib are divided into 3 dosage levels, including 8mg, 10mg, 12mg; Oral administration of anlotinib was given, qd, D1-D14; taken on an empty stomach, Every 3 weeks is a cycle, a total of 2 cycles; Starting from the first level of anlotinib, the dose will be ramped up in sequence.

Conditions
Sarcoma
Being tested
Anlotinib hydrochloride
Medical subject headings
Sarcoma

What participants receive

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

  • Anlotinib hydrochlorideDrug

    Anlotinib are divided into 3 dosage levels, including 8mg, 10mg, 12mg; Oral administration of anlotinib was given, qd, D1-D14; taken on an empty stomach, Every 3 weeks is a cycle, a total of 2 cycles; Starting from the first level of anlotinib, the dose will be ramped up in sequence.

Study groups in NCT04659733
Study groupRoleWhat they receive
Anlotinib hydrochlorideExperimentalNot described
Receives: Drug: Anlotinib hydrochloride

What is being measured

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

  1. MTD of antinib

    Maximum tolerated dose of antinib

    Measured: Time Frame: From observation up to 28 days

Timeline

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

  1. First posted9 Dec 2020
  2. Study start30 Dec 2020 (estimated)
  3. Primary completion15 Dec 2022 (estimated)
  4. Study completion30 Dec 2022 (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 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
36 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04659733
Sponsor's protocol ID
anlotinib
Status last verified
Dec 2020
First submitted
2 Dec 2020
Last updated
9 Dec 2020
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Lu S, Que Y, Liu D, Sun F, Yao X, Deng L, Zhan J, Huang J, Cai R, Wang X, Zhu S, Zhen Z, Zhu J, Wang J, Zhang Y. Safety and feasibility of anlotinib in children with high risk, recurrent or refractory sarcomas: an open-label, single-centre, single-arm, phase Ia/Ib trial. EClinicalMedicine. 2025 May 23;84:103258. doi: 10.1016/j.eclinm.2025.103258. eCollection 2025 Jun.

    PubMed 40496885

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Anlotinib hydrochloride in people with Sarcoma, run by Yizhuo Zhang.

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 26 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 9 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.

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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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 Yizhuo Zhang (02087342460, zhangyzh@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

MTD of antinib (time frame: Time Frame: From observation up to 28 days). 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 NCT04659733, which also lists 1 linked publication.

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 9 Dec 2020.

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