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Trial Title:
Lenvatinib for Advanced Bone and Soft Tissue Sarcoma
NCT ID:
NCT05617859
Condition:
Effectiveness
Sexuality
Conditions: Official terms:
Sarcoma
Lenvatinib
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Lenvatinib mesylate capsule
Description:
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.
Arm group label:
Lenvatinib mesylate capsule
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.
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Ages 10-70, both male and female.
2. The Eastern Collaborative Oncology Group (ECOG) physical status score was 0-1.
Subjects with amputation can be relaxed up to 2 points.
3. The expected survival time was ≥3 months.
4. 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.
5. 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.
6. There were measurable lesions that met RECIST1.1 criteria.
7. 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.
8. 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;
9. Urine routine: urinary protein <2+; If urine protein ≥2+, 24-hour urine protein
quantification must show protein ≤1g;
10. 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.
11. 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.
12. 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.
Exclusion Criteria:
1. C1D1 received the following treatments in the previous 4 weeks:
Radiotherapy, surgery, chemotherapy, immunotherapy for tumors. Other investigational
drugs. Get live attenuated vaccine.
2. Surgery and/or radiation therapy for bone and soft tissue sarcomas were planned
during the study.
3. 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).
4. 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.
5. Hypertension that is not well controlled with antihypertensive medication (systolic
blood pressure > 140 mmHg or diastolic blood pressure >90mmHg).
6. 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.
7. 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).
8. 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.
9. Known allergy to the study drug or any of its excipients.
10. 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).
11. 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.
Gender:
All
Minimum age:
10 Years
Maximum age:
70 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Department of Bone and Soft Tissue ,Henan Cancer Hospital
Address:
City:
Zhengzhou
Country:
China
Status:
Recruiting
Contact:
Last name:
Tian Zhichao, Dr.
Phone:
+8618737187831
Email:
tianzhichhaoyy@163.com
Start date:
April 30, 2023
Completion date:
December 31, 2026
Lead sponsor:
Agency:
Henan Cancer Hospital
Agency class:
Other
Source:
Henan Cancer Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05617859