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EffectivenessPhase 2NCT05617859

Lenvatinib for Advanced Bone and Soft Tissue Sarcoma

A Phase 2 study testing Lenvatinib mesylate capsule in people with Effectiveness and Sexuality, run by Henan Cancer Hospital at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

A total of 60 patients with metastatic/surgically unresectable bone and soft tissue sarcomas who had previously received multi-target TKI therapy and failed were enrolled to evaluate the efficacy and safety. Read more about this study

Who is it for?
Ages 10 to 70 years
Conditions the study is for
Effectiveness, Sexuality
What is being tested?
Lenvatinib mesylate capsule
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteChina
Study dates
30 Apr 2023to 31 Dec 2026
Phase
Phase 2
Are there results?
Not yet: the study is under way

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 10 to 70 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Ages 10-70, both male and female.
  • The Eastern Collaborative Oncology Group (ECOG) physical status score was 0-1. Subjects with amputation can be relaxed up to 2 points.
  • The expected survival time was ≥3 months.
  • Subjects with bone and soft tissue sarcomas with distant metastases or locally advanced disease who were not considered suitable for surgical treatment by the investigator.
  • Patients who had been treated with apatinib or anlotinib in the past, and the efficacy was evaluated as CR\PR\SD\PD, and had no response to other systemic therapy after drug resistance, or had reprogression after more than 3 months.
  • There were measurable lesions that met RECIST1.1 criteria.
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  • All acute toxicities from previous antitumor therapy or surgery resolved to grade 0-1 (according to NCI-CTCAE, version 4.03) or to enrollment/exclusion criteria by day 1 of the first cycle (C1D1), except for toxicities such as hair loss that the investigator considered to pose no safety risk to the subject.
  • Adequate organ and bone marrow function is defined as follows:
  • Blood routine (no blood transfusion, no G-CSF, no medication correction within 14 days before screening) :
  • Neutrophil count (ANC)≥1,500/mm3(1.5×109/L); Platelet count (PLT)≥100,000/mm3(100×109/L); Hemoglobin (Hb)≥9g/dL(90g/L);
  • Blood biochemical:
  • Serum creatinine (Cr)≤1.5× upper limit of normal (ULN) or creatinine clearance (Cockroft-Gault formula)≥60ml/min; Total bilirubin (TBIL)≤1.5×ULN; Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) levels ≤2.5×ULN, and subjects with liver metastases should ≤5×ULN;
  • Blood coagulation function:
  • International normalized ratio (INR)≤1.5, prothrombin time (PT) and activated partial thromboplastin time (APTT)≤1.5×ULN;
  • Urine routine: urinary protein <2+; If urine protein ≥2+, 24-hour urine protein quantification must show protein ≤1g;
  • Thyroid function: Thyroid stimulating hormone (TSH)≤ULN; FT3(T3) and FT4(T4) levels should be examined if they are abnormal, and normal FT3(T3) and FT4(T4) levels can be selected.
  • Female subjects of reproductive age must have a negative serum pregnancy test within 7 days prior to medication and be willing to use a medically approved highly effective contraceptive (e.g., intrauterine device, birth control pill, or condom) during the study period and within 3 months after the last administration of the study drug; Male subjects with a female partner of reproductive age were required to undergo surgical sterilization or consent to use an effective method of contraception during the study period and for 3 months after the last study dose.
  • I have AGREED and signed the informed CONSENT, and I am willing AND ABLE TO comply with the planned visit, study treatment, laboratory tests and other trial procedures.

Who cannot join

  • C1D1 received the following treatments in the previous 4 weeks:
  • Radiotherapy, surgery, chemotherapy, immunotherapy for tumors. Other investigational drugs. Get live attenuated vaccine.
  • Surgery and/or radiation therapy for bone and soft tissue sarcomas were planned during the study.
  • Previous use of immunosuppressive drugs within 14 days prior to C1D1, excluding nasal spray and inhaled corticosteroids or physiological doses of systemic steroid hormones (i.e., no more than 10mg/ day of prednisolone or an equivalent physiological dose of another corticosteroid).
  • Severe infection (such as the need for intravenous antibiotic, antifungal, or antiviral medication) within 4 weeks prior to C1D1, or unexplained fever >38.5°C during the screening period/before the first dose.
  • Hypertension that is not well controlled with antihypertensive medication (systolic blood pressure > 140 mmHg or diastolic blood pressure >90mmHg).
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  • Significant bleeding symptoms or clear bleeding tendency occurred within 3 months before C1D1, such as gastrointestinal bleeding, hemorrhagic gastric ulcer, baseline fecal occult blood ++ and above, vasculitis, etc. Or arteriovenous thrombotic events occurring within 6 months before C1D1, such as cerebrovascular accidents (including transient ischemic attack, cerebral hemorrhage, cerebral infarction), deep vein thrombosis and pulmonary embolism; Long-term anticoagulant therapy with warfarin or heparin or long-term antiplatelet therapy (aspirin ≥300mg/ day or clopidogrel ≥75mg/ day) may be required.
  • Active heart disease in the 6 months prior to C1D1, including myocardial infarction and severe/unstable angina pectoris. Left ventricular ejection fraction <50% on echocardiography, poorly controlled arrhythmias (including QTcF interval >450ms in men and >470ms in women).
  • C1D1 had been diagnosed with any other malignancy within 3 years prior to C1D1, except adequately treated basal or squamous cell skin cancer or carcinoma in situ of the cervix.
  • Known allergy to the study drug or any of its excipients.
  • Human immunodeficiency virus (HIV) infection, active hepatitis B (hepatitis B surface antigen positive and HBVDNA≥500IU/ml), and hepatitis C (hepatitis C antibody positive and HCV-RNA above the detection limit of the assay).
  • Concomitant diseases (e.g., poorly controlled hypertension, severe diabetes,neurological or mental disorders, etc.) or any other conditions that, in the judgment of the investigator, seriously endanger the safety of the subjects, may confounding the results of the study, or interfere with the completion of the study.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

China1 site, 1 recruiting

  • Department of Bone and Soft Tissue ,Henan Cancer Hospital

    Zhengzhou, Henan

    Tian Zhichao, Dr., +8618737187831, tianzhichhaoyy@163.com

    Recruiting

Other trials in China

About this study

Official title: A Multicenter, Open, One-arm Phase II Study of Ranvastinib Mesylate Capsules in the Treatment of Advanced Bone and Soft Tissue Sarcoma After Chemotherapy Failure

A total of 60 patients with metastatic/surgically unresectable bone and soft tissue sarcomas who had previously received multi-target TKI therapy and failed were enrolled to evaluate the efficacy and safety.

Read the detailed description

To evaluate the efficacy and safety of lenvatinib mesylate capsule in patients with metastatic/surgically unresectable bone and soft tissue sarcomas who had previously received multitarget TKI therapy and failed.

Being tested
Lenvatinib mesylate capsule
Medical subject headings
Sexuality

What participants receive

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

  • Lenvatinib mesylate capsuleDrug

    Lenvatinib mesylate capsule, 8mg (body weight ≤60kg) or 12mg (body weight >60kg), orally, once daily. Take the medicine about half an hour after meals (the time of taking the medicine should be the same as possible every day) and take it with warm water.

Study groups in NCT05617859
Study groupRoleWhat they receive
Lenvatinib mesylate capsuleOtherEligible subjects with bone and soft tissue sarcoma were selected and treated with the following treatment regimens:Subjects will receive Lenvatinib mesylate capsules, 8mg (body weight ≤60kg) or 12mg (body weight >60kg) orally once daily. Take the medicine about half an hour after meals (the time of taking the medicine should be the same as possible every day) and take it with warm water.
Receives: Drug: Lenvatinib mesylate capsule

What is being measured

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

  1. Progression-free survival

    From the start of treatment to the onset of disease progression or death of the patient

    Measured: Up to approximately 24months

  2. Objective response rate

    Until the tumor progresses or the patient dies or is lost to follow-up or cannot tolerate it

    Measured: Up to approximately 24months

Timeline

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

  1. First posted16 Nov 2022
  2. Study start30 Apr 2023
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completion31 Dec 2026 (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
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05617859
Sponsor's protocol ID
ZZUSC-20
Status last verified
Feb 2023
First submitted
31 Oct 2022
Last updated
21 Aug 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Lenvatinib mesylate capsule in people with Effectiveness and Sexuality, run by Henan Cancer 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 18 inclusion and 12 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: looking for participants now, as of the sponsor's last update on 21 Aug 2023. 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?

This study is still under way. Results are not available in the source record yet.

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

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-free survival (time frame: Up to approximately 24months). The study lists 2 primary outcomes in all. 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 NCT05617859.

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 Aug 2023.

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